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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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522 Postmarket Surveillance Studies

  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Nathan S. Ivey, PhD
Senior Scientific Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4278
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Nathan.Ivey@fda.hhs.gov
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To sort by data column: 332 records  
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Study
Name
Study Status
PS110066 Stryker Orthopaedics for Howmedica Osteonics Corp. (modified) omnifit threaded acetabular component Orthopedic K861723
05/06/2011 Metal ion levels
Terminated
PS090005 DePuy Spine 6.35mm and 5.5mm peek rods Orthopedic K073562
10/05/2009 Fusion, AEs, Surg Procedures
Other
PS110123 Orthopedic Manufacturing Co. Ace 100 degrees tubular plate Orthopedic K920738
05/06/2011 Metal ion levels
Terminated
PS120001 ACell, Inc. Acell Matristem Pelvic Floor Matrix General &
Plastic Surgery
K041140
01/03/2012 AE and effectiveness rates
Study Pending
PS130041 Halt Medical Inc. Acessa system Obstetrics/
Gynecology
K121858
K121858
06/17/2013 1 Newly Enrolled
2 (IDE) Long Term Follow-up
1 Study Pending
2 Progress Adequate
PS110068 Stryker Orthopaedics for Howmedica Osteonics Corp. Acetabular dome and screw hole plugs Orthopedic K920868
05/06/2011 Metal ion levels
Terminated
PS110069 Stryker Orthopaedics for Howmedica Osteonics Corp. Acetabular dome hole plugs Orthopedic K942809
05/06/2011 Metal ion levels
Terminated
PS120094 C.R. Bard Inc. Ajust adjustable single incision sling General &
Plastic Surgery
K092607
01/03/2012 AE and effectiveness rates
Other
PS130038 C.R. Bard Inc. Ajust helical adjustable single-incision sling Obstetrics/
Gynecology
K123179
03/13/2013 PSS
Other
PS110108 Zimmer Allofit acetabular system Orthopedic K003758
05/06/2011 Metal ion levels
Consolidated
PS110098 Zimmer Alpha metasul 28mm and 32mm acetabular inserts, standard and hooded Orthopedic K033943
05/06/2011 Metal ion levels
Consolidated
PS040001 ZOLL Circulation, Inc. Alsius coolgard 3000/coolline catheter thermal regulation system Neurology K014241
03/05/2004 Mortality Study
Completed
PS130039 Coloplast Corp Altis single incision sling system Obstetrics/
Gynecology
K121562
03/13/2013 AE and effectiveness rates
Study Pending
PS110010 Biomet Inc. Altra fx hip system Orthopedic K063614
05/06/2011 Metal Ion Levels
Consolidated
PS110009 Biomet Inc. Altra press-fit hip system Orthopedic K063020
05/06/2011 Metal Ion Levels
Consolidated
PS130046 St. Jude Medical, Inc. Amplatzer Cardiovascular P000039
09/30/2013 Amplatzer ASO
Plan Pending
PS120015 American Medical Systems, Inc. Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix Obstetrics/
Gynecology
K050445
01/03/2012 AE and effectiveness rates
Other
PS120005 American Medical Systems, Inc. Ams elevate anterior & apical prolapse repair system with intepro lite Obstetrics/
Gynecology
K111118
01/03/2012 AE and effectiveness rates
Other
PS120004 American Medical Systems, Inc. Ams elevate anterior & apical prolapse repair system with intepro llite General &
Plastic Surgery
K082677
K121612
01/03/2012 POP AE and effectiveness rates, registry
Progress Adequate
PS120006 American Medical Systems, Inc. Ams elevate apical and posterior prolapse repair system with intepro lite General &
Plastic Surgery
K082730
K082730
K121612
01/03/2012 1 POP AE and Effectiveness rates, registry
2 Elevate System w/InteXen LP
1 Progress Adequate
2 Other
PS120007 American Medical Systems, Inc. Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp General &
Plastic Surgery
K080185
01/03/2012 AE and effectiveness rates
Other
PS120008 American Medical Systems, Inc. Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp Obstetrics/
Gynecology
K111118
01/03/2012 AE and Effectiveness Rates
Other
PS120002 American Medical Systems, Inc. Ams large pore polypropylene mesh Obstetrics/
Gynecology
K040521
01/03/2012 AE and effectiveness rates
Other
PS120003 American Medical Systems, Inc. Ams large pore polypropylene mesh General &
Plastic Surgery
K033636
01/03/2012 AE and effectiveness rates
Other
PS130017 American Medical Systems, Inc. Ams triangle silicone-coated sling and surgical mesh General &
Plastic Surgery
K002721
03/13/2013 PSS
Other
PS010001 Medtronic Vascular Aneurx stent graft system Cardiovascular P990020
06/13/2001 AneuRx Stent Graft System
Completed
PS120009 American Medical Systems, Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix General &
Plastic Surgery
K082387
01/03/2012 Apogee and Perigee System w/IntePro Lite
Other
PS120010 American Medical Systems, Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix General &
Plastic Surgery
K051485
K082730
01/03/2012 1 Apogee AE and Eff Rates
2 Perigee AE and Eff Rates
1 Other
2 Other
PS120011 American Medical Systems, Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix General &
Plastic Surgery
K040537
01/03/2012 AE and effectiveness rates
Other
PS120012 American Medical Systems, Inc. Apogee and perigee systems with intepro lite and intexen lp part of the ams pelvic floor repair system; Ams collagen dermal matrix, ams apogee system with pre-connected collagen dermal matrix, ams perigee system with pre-connected collagen dermal matrix General &
Plastic Surgery
K040623
01/03/2012 AE and effectiveness rates
Other
PS120013 American Medical Systems, Inc. Apogee and perigee systems with pc coated intepro lite General &
Plastic Surgery
K081710
01/03/2012 AE and effectiveness rates
Other
PS110105 Zimmer Apr metasul acetabular insert Orthopedic K993569
05/06/2011 Metal ion levels
Other
PS120033 Caldera Medical Inc. Ascend blue ac mesh; Ascend blue pc mesh General &
Plastic Surgery
K101462
01/03/2012 AE and effectiveness rates
Other
PS120034 Caldera Medical Inc. Ascend blue ac mesh; Ascend blue pc mesh General &
Plastic Surgery
K083722
01/03/2012 AE and effectiveness rates
Other
PS110109 Zimmer Ascendent acetabular system Orthopedic K022985
05/06/2011 Metal ion levels
Other
PS120027 C.R. Bard Inc. Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system General &
Plastic Surgery
K083839
01/03/2012 AE and effectiveness rates
Other
PS120028 C.R. Bard Inc. Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system General &
Plastic Surgery
K063712
01/03/2012 AE and effectiveness rates
Other
PS120029 C.R. Bard Inc. Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system General &
Plastic Surgery
K082571
01/03/2012 AE and effectiveness rates
Other
PS110024 Biomet Inc. Balance hip system Orthopedic K050251
05/06/2011 Metal Ion Levels
Consolidated
PS090003 Applied Spine Technologies, Inc. Bar pedicle screw spinal fixation system Orthopedic K061162
10/05/2009 Fusion, AEs, Surg Procedures
Other
PS120031 C.R. Bard Inc. Bard pelvisoft acellular collagen biomesh General &
Plastic Surgery
K031332
01/03/2012 AE and effectiveness rates
Other
PS120030 C.R. Bard Inc. Bard prolapse repair system Obstetrics/
Gynecology
K101922
01/03/2012 AE and effectiveness rates
Terminated
PS100008 Becton Dickinson Infusion Therapy Systems Bd posiflow/tm positive displacement valve General Hospital K050207
07/21/2010 BSI rate
Other
PS110059 Stryker Orthopaedics for Howmedica Osteonics Corp. Bg proximal femur Orthopedic K790274
05/06/2011 Metal ion levels
Terminated
PS120048 Kensey Nash Corporation DBW DSM Bioblanket surgical mesh General &
Plastic Surgery
K061030
01/03/2012 AE and effectiveness rates
Other
PS120049 Kensey Nash Corporation Bioblanket surgical mesh General &
Plastic Surgery
K043259
01/03/2012 AE and effectiveness rates
Other
PS130040 Cook Biotech Inc. Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts Obstetrics/
Gynecology
K130006
06/17/2013 AE and Effectiveness Rates
Other
PS090004 Biospine Co., Ltd. Bioflex® Orthopedic K072321
10/05/2009 Fusion, AEs, Surg Procedures
Other
PS110022 Biomet Inc. Biomet metal-on-metal hip systems- expanded contraindications Orthopedic K082446
05/06/2011 Metal Ion Levels
Consolidated
PS110023 Biomet Inc. Biomet modular femoral revision system Orthopedic K090757
05/06/2011 Metal Ion Levels
Consolidated
PS110141 Osteotechnology, Inc. Biometric screw fixation cup Orthopedic K922861
05/06/2011 PSS
Terminated
PS120103 Injectx, Inc Biosling bioabsorbable polymer sling & surgical mesh General &
Plastic Surgery
K010533
04/09/2012 PSS
Other
PS120104 Herniamesh SRL Biosling Bioabsorbable Polymer Sling & Surgical Mesh General &
Plastic Surgery
K020652
04/09/2012 AE & Effectiveness Rates
Terminated
PS120040 Cousin Biotech SARL Biotech SAS for Biomesh® Pl and Biomesh® Plug and Patch General &
Plastic Surgery
K002479
01/03/2012 AE and effectiveness rates
Terminated
PS120025 Stella Medical Brennen medical surgical mesh glucamesh/glucatex General &
Plastic Surgery
K021835
01/03/2012 AE and effectiveness rates
Other
PS060003 Cardica, Inc. C-port distal anastomosis system Cardiovascular K040832
K053524
K063644
K070548
06/14/2006 Graft Patency and Technical Failure
Progress Inadequate
PS130024 Caldera Medical Inc. Caldera mesh General &
Plastic Surgery
K060004
03/13/2013 PSS
Other
PS090009 Medtronic Sofamor Danek Cd horizon® agile¿ dynamic stabilization device Orthopedic K060615
10/05/2009 Fusion, AEs, Surg Procedures
Other
PS090008 Medtronic Cd horizon® peek rods Orthopedic K050809
K063670
10/05/2009 Fusion, AEs, Surg Procedures
Progress Inadequate
PS100003 ICU Medical, Inc. Clc2000 General Hospital K973167
07/21/2010 BSI rate
Other
PS100004 ICU Medical, Inc. Clc2000 catheter patency device General Hospital K021692
07/21/2010 BSI rate
Other
PS110102 Zimmer Clx acetabular cup (wagner) for cementless fixation Orthopedic K870924
05/06/2011 Metal ion levels
Terminated
PS110021 Biomet Inc. Compress segmental femoral replacement system Orthopedic K043547
05/06/2011 Metal Ion Levels
Consolidated
PS110013 Biomet Inc. Compress segmental femoral replacement system (short spindle and anchor plug) Orthopedic K062998
05/06/2011 Metal Ion Levels
Consolidated
PS110148 Wright Medical Technology, Inc. Conserve bio foam shell Orthopedic K110029
05/06/2011 Metal ion levels
Consolidated
PS110079 Wright Medical Technology, Inc. Conserve plus ha acetabular shells Orthopedic K042530
05/06/2011 Metal ion levels
Consolidated
PS110084 Wright Medical Technology, Inc. Conserve plus quadrafix acetabular shell Orthopedic K060356
05/06/2011 Metal ion levels
Consolidated
PS110075 Wright Medical Technology, Inc. Conserve plus revision shell and conserve plus thick shell Orthopedic K042530
05/06/2011 Metal ion levels
Consolidated
PS110073 Wright Medical Technology, Inc. Conserve plus spiked acetabular shells and conserve total 56mm femoral head Orthopedic K031963
05/06/2011 Metal ion levels
Consolidated
PS110081 Wright Medical Technology, Inc. Conserve total femoral head Orthopedic K051348
05/06/2011 Metal ion levels
Consolidated
PS130015 DIMA Contasure Needleless sling General &
Plastic Surgery
K063136
03/13/2013 AE and Effectiveness Rates
Progress Adequate
PS110131 C.R. Bard Inc. CONTOUR II LINK SP TOTAL HIP PROSTHESIS Orthopedic K821066
05/06/2011 Metal ion levels
Terminated
PS110096 Zimmer Converge reti-lock multi-hole reinforcement cup Orthopedic K032348
05/06/2011 Metal ion levels
Consolidated
PS110042 Johnson and Johnson Corail amt hip prosthesis Orthopedic K042992
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS100002 Amsino International, Inc Cortez needle free iv connector General Hospital K003254
07/21/2010 BSI rate
Other
PS090014 Ulrich Medical USA Cosmic system Orthopedic K080841
10/05/2009 Fusion, AEs, Surg Procedures
Other
PS110135 Implantology LLC Cps acetabular component Orthopedic K915527
K915529
05/06/2011 Metal ion levels
Other
PS110050 Johnson and Johnson Depuy asphere m-spec head Orthopedic K082585
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS110049 Johnson and Johnson Depuy asr 300 acetabular cup system Orthopedic K073413
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS110041 Johnson and Johnson Depuy asr modular acetabular cup system Orthopedic K040627
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS110045 Johnson and Johnson Depuy asr taper sleeve adapter Orthopedic K070359
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS110048 Johnson and Johnson Depuy asr xl modular acetabular cup system Orthopedic K080991
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS110051 Johnson and Johnson Depuy c-stem amt Orthopedic K082239
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS110046 Johnson and Johnson Depuy corail amt dysplasia hip prosthesis Orthopedic K070554
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS110149 Depuy Orthopaedics, Inc. Depuy corail hip system, revision stem Orthopedic K093736
05/06/2011 PSS
Terminated
PS110053 Johnson and Johnson Depuy pinnacle 100 with gription acetabular cups Orthopedic K090998
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS110040 Johnson and Johnson Depuy pinnacle metal-on-metal acetabular cup liner Orthopedic K023786
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS110044 Johnson and Johnson Depuy pinnacle metal-on-metal acetabular cup liners Orthopedic K062426
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS110052 Johnson and Johnson Depuy pinnacle metal-on-metal acetabular cup liners Orthopedic K083642
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS110038 Johnson and Johnson Depuy pinnacle metal-on-metal acetabular cup liners, Pinnacle with Gription Acetabular Cups, ASR XL Modular Acetabular Cup System, ASR 300 Acetabular Cup System, ASR Taper Sleeve Adapter, C-Stem AMT, Tri-Lock Bone Preservation Stem, Corail AMT Dysplasi Orthopedic K080991
K003523
K073413
K070359
K082239
K040627
K093646
K083642
K002883
K023786
K062426
K090998
K073570
K070554
K042992
K061221
K082585
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Progress Inadequate
2 Progress Inadequate
PS110054 Johnson and Johnson Depuy pinnacle with gription acetabular cups Orthopedic K093646
K093646
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS110047 Johnson and Johnson Depuy tri-lock bone preservation stem Orthopedic K073570
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS120026 Stella Medical Dermmatrix surgical mesh General &
Plastic Surgery
K021160
01/03/2012 AE and effectiveness rates
Other
PS130026 Caldera Medical Inc. Desara mesh Obstetrics/
Gynecology
K101169
03/13/2013 PSS
Terminated
PS130027 Caldera Medical Inc. Desara mesh Obstetrics/
Gynecology
K112609
03/13/2013 PSS
Terminated
PS130025 Caldera Medical Inc. Desara mesh sling, model cal-dsol Obstetrics/
Gynecology
K072456
03/13/2013 PSS
Terminated
PS120102 Caldera Medical Inc. Desara mini Obstetrics/
Gynecology
K103418
04/09/2012 AE & Effectiveness Rates
Other
PS110034 Encore Medical Djo surgical revision femoral hip system, model 428-14/24-140/200; 428-00-050/110 Orthopedic K092331
K092331
05/06/2011 1 Clinical Study
2 Device Retrieval Study
1 Consolidated
2 Consolidated
PS090011 Paradigm Spine Dss stabilization system Orthopedic K072969
10/05/2009 Fusion, AEs, Surg Procedures
Progress Inadequate
PS110043 Johnson and Johnson Dupuy s-rom std hip stem prosthesis Orthopedic K061221
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS110110 Zimmer Durom acetabular component and metasul ldh large diameter heads Orthopedic K053536
05/06/2011 Metal ion levels
Consolidated
PS110086 Wright Medical Technology, Inc. Dynasty acetabular shell and cocr acetabular liner Orthopedic K061844
05/06/2011 Metal ion levels
Consolidated
PS110087 Wright Medical Technology, Inc. Dynasty acetabular system Orthopedic K070785
05/06/2011 Metal ion levels
Consolidated
PS110090 Wright Medical Technology, Inc. Dynasty porous acetabular shell, dynasty polyethylene acetabular liner, dynasty metal acetabular liner Orthopedic K082924
05/06/2011 Metal ion levels
Consolidated
PS110011 Biomet Inc. Echo bi-metric press-fit stems Orthopedic K070274
05/06/2011 Metal Ion Levels
Consolidated
PS120014 American Medical Systems, Inc. Elevate prolapse repair system with pc coated intepro lite- apical and posterior prolapse repair system anterior and ap General &
Plastic Surgery
K090713
01/03/2012 AE and effectiveness rates
Other
PS130011 American Medical Systems, Inc. Elevate prolapse repair systems Obstetrics/
Gynecology
K121612
03/13/2013 AE & Effectiveness Rates
Terminated
PS110029 Encore Medical Encore clp offset total hip system, Metal/Metal Hip System,FMP Metal/Metal Acetabular insert, Revelation Stem,DJO Surgical Revision Femoral I-lip System, Metal Backed Acetabular Component, Orthopedic K052320
K083651
K092331
K063414
K052320
K040354
K070221
K950542
K003250
05/06/2011 1 Clinical Study
2 Device Retrieval Study
1 Progress Inadequate
2 Progress Inadequate
PS120100 IBI Israel Biomedical Innovations EndoFast Reliant¿. General &
Plastic Surgery
K080836
04/09/2012 AE and Effectiveness Rates
Other
PS120101 IBI Israel Biomedical Innovations EndoFast Reliant¿. General &
Plastic Surgery
K060329
04/09/2012 AE & Effectiveness Rates
Other
PS110097 Zimmer Epsilon metasul 32mm acetabular inserts, standard and hooded Orthopedic K033634
05/06/2011 Metal ion levels
Consolidated
PS120035 Coloplast Corp Exair Anterior and Posterior Prolapse Repair Systems General &
Plastic Surgery
K083499
K112386
01/03/2012 AE and effectiveness rates
Study Pending
PS120036 Coloplast Corp Exair anterior and posterior prolapse repair systems Obstetrics/
Gynecology
K112386
K083499
01/03/2012 AE and effectiveness rates
Consolidated
PS110036 Encore Medical Fmp metal/metal acetabular insert Orthopedic K003250
K003250
05/06/2011 1 Clinical Study
2 Device Retrieval Study
1 Consolidated
2 Consolidated
PS110032 Encore Medical Fmp metal/metal acetabular insert, 499-28,449-34, 499-38 Orthopedic K070221
K070221
05/06/2011 1 Clinical Study
2 Device Retrieval Study
1 Consolidated
2 Consolidated
PS120058 Organogenesis, Inc. FORTAFLEX SURGICAL MESH General &
Plastic Surgery
K021105
01/03/2012 AE and effectiveness rates
Other
PS120059 Organogenesis, Inc. FORTAFLEX SURGICAL MESH General &
Plastic Surgery
K020049
01/03/2012 AE and effectiveness rates
Other
PS120060 Organogenesis, Inc. FORTAFLEX SURGICAL MESH General &
Plastic Surgery
K011025
01/03/2012 AE and effectiveness rates
Other
PS130031 Organogenesis, Inc. Fortaflex surgical sling General &
Plastic Surgery
K011027
03/13/2013 PSS
Other
PS130032 Organogenesis, Inc. FortaPerm surgical sling General &
Plastic Surgery
K021107
03/13/2013 PSS
Other
PS110136 Implantology LLC Fpc/sfpc/rfpc acetabular component Orthopedic K915527
K915529
05/06/2011 Metal ion levels
Other
PS110128 Advanced Bioresearch Association Freeman acetabular cup Orthopedic K852699
05/06/2011 Metal ion levels
Terminated
PS120085 W.L. Gore & Associates, Inc. Gore bioabsorbable mesh General &
Plastic Surgery
K033671
01/03/2012 AE and effectiveness rates
Other
PS130001 Boston Scientific Corporation Greenfield vena cava filters Cardiovascular K951508
K912035
K964284
K955396
02/28/2013 Greenfield PS study
Completed
PS120096 Coloplast Corp Gyne ideas minitape rp device General &
Plastic Surgery
K023898
01/03/2012 AE and effectiveness rates
Other
PS120043 Ethicon, Inc. Gynecare prolift +m* pelvic floor repair systems General &
Plastic Surgery
K071512
01/03/2012 AE and effectiveness rates
Other
PS120044 Ethicon, Inc. Gynecare prosima pelvic floor repair systems General &
Plastic Surgery
K063562
01/03/2012 AE and effectiveness rates
Other
PS120095 Ethicon, Inc. Gynecare tvt secur system General &
Plastic Surgery
K052401
01/03/2012 AE and effectiveness rates
Other
PS120046 Ethicon, Inc. Gynemesh prolene soft (polypropylene) nonabsorbable synthetic surgical mesh for pelvic floor repair Obstetrics/
Gynecology
K013718
01/03/2012 AE and effectiveness rates
Other
PS110139 Med-Tek Corp. H.N. Metal backed acetabular cup, noncemented Orthopedic K901626
05/06/2011 Metal ion levels
Terminated
PS130013 Herniamesh SRL Hemiamesh t-sling General &
Plastic Surgery
K020652
03/13/2013 PSS
Terminated
PS110143 Howmedica Osteonics Corporation Howmedica threaded acetabular component Orthopedic K850840
05/06/2011 Metal ion levels
Terminated
PS120066 Promethean Surgical Devices, Inc. Hydrocoat mesh General &
Plastic Surgery
K090271
01/03/2012 AE and effectiveness rates
Other
PS120061 Smith & Nephew, Inc Immix plastifilm General &
Plastic Surgery
K024199
01/03/2012 AE and effectiveness rates
Other
PS120062 Smith & Nephew Immix thin film models: Pss-004-s pss-004-sp pss-004-m pss-004-mp pss-004-l pss-004-lp General &
Plastic Surgery
K032673
01/03/2012 AE and effectiveness rates
Other
PS110106 Zimmer Inter-op metasul acetabular system Orthopedic K974728
05/06/2011 Metal ion levels
Consolidated
PS110107 Zimmer Inter-op metasul hooded and protrusio acetabular inserts Orthopedic K001536
05/06/2011 Metal ion levels
Other
PS090012 Alphatec Spine Isobar semi-rigid spinal system & dual dampener Orthopedic K991326
K071261
10/05/2009 Fusion, AEs, Surg Procedures
Other
PS100007 Baxter Healthcare Corporation Iv/catheter extension set with nac plus needleless access connector and nac plus needleless access connector General Hospital K042936
07/21/2010 BSI rate
Other
PS100012 CareFusion Ivac needle free administration sets General Hospital K960280
07/21/2010 BSI rate
Other
PS130028 Covidien Ivs tunneller Neurology K010035
03/13/2013 PSS
Other
PS130029 Covidien Ivs tunneller devices General &
Plastic Surgery
K073164
03/13/2013 PSS
Other
PS090001 Szabocsik and Associates Jsz orthokeratology contact lenses for overnight wear Ophthalmic P040029
08/07/2009 Microbial Keratitis
Other
PS120051 Kensey Nash Corporation Kensey nash ecm surgical patch General &
Plastic Surgery
K094061
01/03/2012 AE and effectiveness rates
Other
PS110007 Biomet Inc. Lateralized taperloc microplasty femoral components Orthopedic K062994
05/06/2011 Metal Ion Levels
Consolidated
PS110119 Link America, Inc. Lidgrer-lund acetabular sockets Orthopedic K852369
05/06/2011 Metal ion levels
Terminated
PS110078 Wright Medical Technology, Inc. Lineage ha acetabular shells Orthopedic K043099
05/06/2011 Metal ion levels
Consolidated
PS110121 Waldemar Link GMBH & Co. KG Link cementless screw-in acetabular cup Orthopedic K843940
05/06/2011 Metal ion levels
Terminated
PS110122 Waldemar Link GMBH & Co. KG Link cementless screw-in acetabular cup Orthopedic K843950
05/06/2011 Metal ion levels
Terminated
PS110120 Link America, Inc. Link metal-backed acetabular cups Orthopedic K854935
05/06/2011 Metal ion levels
Terminated
PS130010 Wright Medical Technology, Inc. Link metal-backed acetabular cups Orthopedic K821066
03/20/2013 PSS
Terminated
PS130009 Wright Medical Technology, Inc. Linked metal-backed acetabular cups Orthopedic K854935
03/20/2013 PSS
Other
PS120021 Boston Scientific Corporation Lite pelvic floor repair kits Obstetrics/
Gynecology
K103426
K103426
K103426
K103426
01/03/2012 1 AE and effectiveness rates for Uphold LITE
2 DUET LITE
3 Posterior LITE
4 Anterior LITE
1 Other
2 Other
3 Other
4 Other
PS110015 Biomet Inc. M2a 28mm ringloc liner Orthopedic K002379
05/06/2011 Metal Ion Levels
Consolidated
PS110016 Biomet Inc. M2a acetabular system Orthopedic K011110
05/06/2011 Metal Ion Levels
Consolidated
PS110006 Biomet Inc. M2a magnum 12/14 taper inserts and one-piece modular heads Orthopedic K061423
05/06/2011 Metal Ion Levels
Consolidated
PS110017 Biomet Inc. M2a magnum system Orthopedic K042037
05/06/2011 Metal Ion Levels
Consolidated
PS110008 Biomet Inc. M2a-magnum tri-spike acetabular component Orthopedic K062995
05/06/2011 Metal Ion Levels
Consolidated
PS110019 Biomet Inc. M2a/c2a acetabular system Orthopedic K042841
05/06/2011 Metal Ion Levels
Consolidated
PS120052 Macropore Biosurgery Inc. Macropore surgiwrap (ts) General &
Plastic Surgery
K012025
01/03/2012 AE and effectiveness rates
Other
PS110018 Biomet Inc. Mallory-head modular calcar stems with interlocking slots Orthopedic K042774
05/06/2011 Metal Ion Levels
Consolidated
PS100009 CareFusion Maxplus tru-swab positive displacement connector General Hospital K051939
07/21/2010 BSI rate
Progress Inadequate
PS100010 CareFusion Maxplus tru-swab positive displacement connector General Hospital K072542
07/21/2010 BSI rate
Progress Inadequate
PS120050 Kensey Nash Corporation Medeor matrix models 30010-xx (hydrated); 30020-xx (dry) General &
Plastic Surgery
K091499
01/03/2012 AE and effectiveness rates
Other
PS120037 Coloplast Corp Mentor novasilk mesh General &
Plastic Surgery
K053414
01/03/2012 AE and effectiveness rates
Other
PS130012 Coloplast Corp Mentor suspend sling General &
Plastic Surgery
K980483
03/13/2013 PSS
Other
PS130030 Coloplast Corp Mentor suspend sling General &
Plastic Surgery
K980483
03/13/2013 PSS
Other
PS110035 Encore Medical Metal backed acetabular component Orthopedic K950542
K950542
05/06/2011 1 Clinical Study
2 Device Retrieval Study
1 Consolidated
2 Consolidated
PS110014 Biomet Inc. Metal on metal acetabular system Orthopedic K993438
05/06/2011 Metal Ion Levels
Consolidated
PS110070 MicroPort Metal transcend articulation system Orthopedic K004043
K110029
K021349
K031963
K041586
K042530
K041114
K043073
K043099
K082924
K051348
K052915
K053588
K060356
K060358
K061844
K070785
K080663
K081090
K091423
05/06/2011 Metal ion levels
Progress Inadequate
PS110071 Wright Medical Technology, Inc. Metal transcend articulation system Orthopedic K004043
05/06/2011 Metal ion levels
Consolidated
PS110072 Wright Medical Technology, Inc. Metal transcend articulation system (larger sizes) Orthopedic K021349
05/06/2011 Metal ion levels
Consolidated
PS110030 Encore Medical Metal/metal hip system Orthopedic K040354
K040354
05/06/2011 1 Clinical Study
2 Device Retrieval Study
1 Consolidated
2 Consolidated
PS110113 Zimmer Metasul taper liners, metasul femoral heads Orthopedic K091973
05/06/2011 1 Cross-sectional Plan
2 Prospective Study plan
1 Consolidated
2 Terminated
PS110065 Stryker Orthopaedics for Howmedica Osteonics Corp. Micro-struc. Acetabular compon- mc2p Orthopedic K850352
05/06/2011 Metal ion levels
Terminated
PS100001 MicroVention, Inc. Microvention hydrocoil-soft-frame Neurology K020434
K032590
K033836
K041551
K050954
K070656
K080666
K090357
04/15/2010 1 HydroCoil Study
2 HydroSoft/HydroFrame Study
1 Progress Adequate
2 Progress Adequate
PS120089 American Medical Systems, Inc. Miniarc precise single-incision sling system General &
Plastic Surgery
K100807
01/03/2012 SUI AE and Effectiveness rates
Progress Adequate
PS120090 American Medical Systems, Inc. Miniarc precise single-incision sling system General &
Plastic Surgery
K070065
01/03/2012 AE and effectiveness rates
Other
PS120091 American Medical Systems, Inc. Miniarc precise single-incision sling system General &
Plastic Surgery
K071902
01/03/2012 SUI AE and Effectiveness rates
Progress Adequate
PS120092 American Medical Systems, Inc. Miniarc precise single-incision sling system General &
Plastic Surgery
K073703
01/03/2012 SUI AE and Effectiveness rates
Progress Adequate
PS130037 American Medical Systems, Inc. Miniarc pro single-incision sling system Obstetrics/
Gynecology
K121641
03/13/2013 PSS
Other
PS120055 Coloplast Corp Minimesh polypropylene mesh General &
Plastic Surgery
K053361
K053361
01/03/2012 1 AE and effectiveness rates
2 Restorelle P, EZA and L model
1 Other
2 Other
PS120056 Coloplast Corp Minimesh polypropylene mesh General &
Plastic Surgery
K041632
K041632
01/03/2012 1 AE and effectiveness rates
2 Restorelle P, EZA and L models
1 Other
2 Other
PS120099 Prosurg, Inc. Minisling adjustable polymer sling & surgical mesh with self-anchoring system (easy lift prolapse repair & minisling) General &
Plastic Surgery
K070846
01/03/2012 AE and effectiveness rates
Other
PS120097 Coloplast Corp Minitape urethral sling General &
Plastic Surgery
K091180
01/03/2012 AE and effectiveness rates
Other
PS120098 Coloplast Corp Minitape urethral sling General &
Plastic Surgery
K073646
01/03/2012 AE and effectiveness rates
Other
PS120084 W.L. Gore & Associates, Inc. Modification to seamguard staple line reinforcement material General &
Plastic Surgery
K001789
01/03/2012 AE and effectiveness rates
Other
PS130022 Boston Scientific Corporation Modification to Surgical Mesh Polymeric Obstetrics/
Gynecology
K040787
03/13/2013 PSS
Plan Overdue
PS130021 Boston Scientific Corporation Modification to trelex mesh surgical mesh Obstetrics/
Gynecology
K020110
03/13/2013 PSS
Other
PS110031 Encore Medical Modification to: Fmp metal/metal acetabular insert, models 499-28, 499-34, 499-38 Orthopedic K063414
K063414
05/06/2011 1 Clinical Study
2 Device Retrieval Study
1 Consolidated
2 Consolidated
PS110100 Zimmer Modified anatomic porous replacement apr acetabula Orthopedic K850793
05/06/2011 Metal ion levels
Terminated
PS110146 Turnkey Intergration USA, Inc. Modified freeman acetabular cup Orthopedic K902110
05/06/2011 Metal ion levels
Terminated
PS110147 Turnkey Intergration USA, Inc. Modified freeman revision acetabular cup Orthopedic K902111
05/06/2011 Metal ion levels
Terminated
PS090015 Exactech, Inc. Modified vertiflex spinal screw system (with dynabolt rods) Orthopedic K073143
10/05/2009 Fusion, AEs, Surg Procedures
Progress Inadequate
PS110133 Downs Surgical Ltd. MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT Orthopedic K871956
05/06/2011 Metal ion levels
Terminated
PS130045 Aesculap, Inc. Modular range of ring pros. For hip replacement Orthopedic K083651
07/29/2013 PSS
Terminated
PS110125 Advanced Bioresearch Association Muller titanium backed acetabular cup component Orthopedic K844482
05/06/2011 Metal ion levels
Terminated
PS110124 Advanced Bioresearch Association Natural lock acetabular component Orthopedic K830662
05/06/2011 Metal ion levels
Terminated
PS090010 Synthes Spine Ngarde system Orthopedic K061774
10/05/2009 Fusion, AEs, Surg Procedures
Other
PS100011 Becton Dickinson Infusion Therapy Systems Nima needleless injectionsite master adapter with posiflow positive displacement feature, and iv sets General Hospital K964918
07/21/2010 BSI rate
Other
PS110064 Stryker Orthopaedics for Howmedica Osteonics Corp. Omnifit threaded acetabular components 2005 series Orthopedic K851404
05/06/2011 Metal ion levels
Terminated
PS110067 Stryker Orthopaedics for Howmedica Osteonics Corp. Omniflex normalized hip stem for press-fit fixat Orthopedic K872768
05/06/2011 Metal ion levels
Terminated
PS130016 Promedon Ophira mini sling system Obstetrics/
Gynecology
K110420
03/13/2013 PSS
Other
PS120063 Synovis Surgical Innovation Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh General &
Plastic Surgery
K090288
01/03/2012 AE and effectiveness rates
Terminated
PS120064 Synovis Surgical Innovation Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh General &
Plastic Surgery
K071065
01/03/2012 AE and effectiveness rates
Terminated
PS120065 Synovis Surgical Innovations Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh General &
Plastic Surgery
K043388
01/03/2012 AE and effectiveness rates
Terminated
PS110001 Vermillion, Inc Ova1 Immunology K081754
01/31/2011 OVA1 Performance in Pre and Post Menopausal Women
Progress Inadequate
PS110056 Johnson and Johnson P.F.C. APICAL PLUG Orthopedic K944769
05/06/2011 Metal ion levels
Terminated
PS110140 Orthopaedic Device Corp. P.T.H. METAL-BACKED ACETABULAR CUP Orthopedic K870234
05/06/2011 Metal ion levels
Terminated
PS060002 The Ohio State University Paragon crt 100 lens and boston vision shaping treatment (vst) lens for ook Ophthalmic P870024/S043
P010062/S001
05/25/2006 Microbial Keratitis Study
Completed
PS110012 Biomet Inc. Parallel-sided extensively coated femoral stems Orthopedic K073637
05/06/2011 Metal Ion Levels
Consolidated
PS120071 Covidien Parietene duo and quadra polypropylene meshes General &
Plastic Surgery
K072951
01/03/2012 AE and effectiveness rates
Other
PS120074 Sofradim Production Parietex General &
Plastic Surgery
K982532
01/03/2012 AE and effectiveness rates
Terminated
PS110003 TMJ Concepts Patient-fitted tmj reconstruction prosthesis system Dental P980052
02/04/2011 Time to Revision and Explant Analysis
Progress Inadequate
PS110060 Stryker Orthopaedics for Howmedica Osteonics Corp. Pca acetabular insert ii Orthopedic K921384
05/06/2011 Metal ion levels
Terminated
PS110062 Stryker Orthopaedics for Howmedica Osteonics Corp. Pca acetabular insert ii, additional sizes, styles Orthopedic K934440
05/06/2011 Metal ion levels
Terminated
PS110061 Stryker Orthopaedics for Howmedica Osteonics Corp. Pca(r) solid back acetabula shell Orthopedic K930833
05/06/2011 Metal ion levels
Terminated
PS120022 Boston Scientific Corporation Pelvic floor repair system (pinnacle duet) General &
Plastic Surgery
K091131
01/03/2012 AE and effectiveness rates-Duet
Other
PS120053 Herniamesh SRL Pelvimesh / hermesh 7 General &
Plastic Surgery
K070625
01/03/2012 AE and effectiveness rates
Other
PS120016 Synovis Surgical Innovations / Baxter Peri-guard cv peri-guard ocu-guard supple peri-guard peri-strips - sleeve peri-strips-strips peri-strips dry vasc General &
Plastic Surgery
K983162
01/03/2012 AE and effectiveness rates
Terminated
PS120019 Synovis Surgical Innovations / Baxter Peri-guard pericardium General &
Plastic Surgery
K961811
01/03/2012 AE and effectiveness rates
Terminated
PS120017 Synovis Surgical Innovations Peri-strips Obstetrics/
Gynecology
K940205
01/03/2012 AE and effectiveness rates
Other
PS120075 Covidien Permacol surgical implant t-piece permacol surgical implant rectocele-piece models 5928-150 5645-150 General &
Plastic Surgery
K050355
01/03/2012 AE and effectiveness rates
Other
PS120076 Covidien Permacol surgical implant t-piece permacol surgical implant rectocele-piece models 5928-150 5645-150; Permacol surgical implant General &
Plastic Surgery
K992556
01/03/2012 AE and effectiveness rates
Other
PS130019 American Medical Systems, Inc. Pfr sling system, (part of the pelvic floor repair system) General &
Plastic Surgery
K090934
03/13/2013 PSS
Other
PS060001 Philips Medical Systems, Heartstream Philips heartstart home otc defibrillator Cardiovascular K040904
12/07/2005 non-prescription use
Completed
PS130044 Boston Scientific Corporation Pinnacle LITE Pelvic Floor Repair Kits - Uphold Lite Posterior and Uphold 07/03/2013 1 Uphold Lite
2 Posterior Lite
1 Study Pending
2 Other
PS110039 Johnson and Johnson Pinnacle metal-on-metal acetabular cup liners Orthopedic K002883
05/06/2011 1 Metal ion levels
2 Explant Analysis
1 Consolidated
2 Consolidated
PS120023 Boston Scientific Corporation Pinnacle pelvic floor repair kit ii (uphold) General &
Plastic Surgery
K081048
01/03/2012 AE and effectiveness rates-Uphold
Other
PS120024 Boston Scientific Corporation Pinnacle pelvic floor repair kits (pinnacle) General &
Plastic Surgery
K071957
K071957
01/03/2012 1 AE and effectiveness rates-Anterior
2 Posterior
1 Other
2 Other
PS110126 Advanced Bioresearch Association Pm cementless screw-in acetabular cup Orthopedic K850773
05/06/2011 Metal ion levels
Terminated
PS120067 Proxy Biomedical Ltd. Polyform synthetic mesh Obstetrics/
Gynecology
K051245
01/03/2012 AE and effectiveness rates
Terminated
PS120032 Caldera Medical Inc. Popmesh General &
Plastic Surgery
K053424
01/03/2012 AE and effectiveness rates-PoP Mesh
Other
PS110020 Biomet Inc. Porous coated acetabular components Orthopedic K050124
05/06/2011 Metal Ion Levels
Consolidated
PS110005 Biomet Inc. Porous titanium acetabular augments, M2a Magnum 12/14 Taper Inserts and One¿Piece Modular Heads,Lateralized Taperloc Microplasty Femoral,M2a Magnum Tri-Spike Acetabular Component, Altra Press-fit Hip System, Echo Bi¿Metric Press-Fit Stems,Parallel-Side Orthopedic K052888
K061423
K062994
K062995
K063002
K063514
K070274
K073637
K062998
K993438
K002379
K011110
K042037
K042774
K042841
K050124
K043547
K082446
K090757
K050251
K050441
K093235
K852351
05/06/2011 1 Metal Ion Levels
2 Explant Analysis
1 Progress Adequate
2 Progress Adequate
PS110077 Wright Medical Technology, Inc. Procotyl-e acetabular system Orthopedic K043073
05/06/2011 Metal ion levels
Consolidated
PS110083 Wright Medical Technology, Inc. Profemur lx hip stem Orthopedic K053588
05/06/2011 Metal ion levels
Consolidated
PS110091 Wright Medical Technology, Inc. Profemur hip system modular necks Orthopedic K091423
05/06/2011 Metal ion levels
Consolidated
PS110089 Wright Medical Technology, Inc. Profemur lx 5/8 coated hip stem Orthopedic K081090
05/06/2011 Metal ion levels
Consolidated
PS110088 Wright Medical Technology, Inc. Profemur lx revision 5/8 coated hip stem Orthopedic K080663
05/06/2011 Metal ion levels
Consolidated
PS110080 Wright Medical Technology, Inc. Profemur renaissance hip stem Orthopedic K082924
05/06/2011 Metal ion levels
Consolidated
PS110074 Wright Medical Technology, Inc. Profemur s hip stem Orthopedic K041586
05/06/2011 Metal ion levels
Consolidated
PS110076 Wright Medical Technology, Inc. Profemur tapered hip stem Orthopedic K041114
05/06/2011 Metal ion levels
Consolidated
PS110085 Wright Medical Technology, Inc. Profemur tl hip stem Orthopedic K060358
05/06/2011 Metal ion levels
Consolidated
PS110082 Wright Medical Technology, Inc. Profemur xtr hip stem Orthopedic K052915
05/06/2011 Metal ion levels
Consolidated
PS110055 Johnson and Johnson PROFILE FEMORAL HIP Orthopedic K850055
05/06/2011 Metal ion levels
Terminated
PS120041 CryoLife, Inc. Propatch soft tissue repair matrix General &
Plastic Surgery
K061892
01/03/2012 AE and effectiveness rates
Other
PS120042 CryoLife, Inc. Propatch soft tissue repair matrix General &
Plastic Surgery
K101587
01/03/2012 AE and effectiveness rates
Terminated
PS110057 Stryker Orthopaedics for Howmedica Osteonics Corp. Prosthesis, vidal total hip Obstetrics/
Gynecology
K770472
05/06/2011 Metal ion levels
Terminated
PS090006 Globus Medical, Inc. Protex rods Orthopedic K042953
10/05/2009 Fusion, AEs, Surg Procedures
Other
PS120106 Coloplast Corp. Restorelle polypropylene mesh General &
Plastic Surgery
K103568
K092207
04/09/2012 1 AE & Effectiveness Rates
2 Restorelle P, EZA, EZP, and L models
1 Study Pending
2 Other
PS120038 Coloplast Corp Restorelle polypropylene mesh; Restorelle polypropylene mesh General &
Plastic Surgery
K103568
K103568
01/03/2012 1 AE and effectiveness rates
2 Restorelle P, EZA, EZP, and L models
1 Other
2 Other
PS110033 Encore Medical Revelation stem, model 427-21/42-080/180 Orthopedic K083651
K083651
05/06/2011 1 Clinical Study
2 Device Retrieval Study
1 Consolidated
2 Consolidated
PS120111 St. Jude Medical, Inc. Riata, quicksite, quickflex, durata Cardiovascular P950022/S014
P950022/S018
P950022/S024
P030054/S004
P030054/S018
P030054/S049
P950022/S042
08/16/2012 Lead Externalization and Abrasion
Progress Adequate
PS130043 Aesculap, Inc. Ring upm total hip replacement Orthopedic K070221
07/29/2013 PSS
Terminated
PS110132 Downs Surgical Ltd. RING UPM TOTAL HIP REPLACEMENT Orthopedic K864515
05/06/2011 Metal ion levels
Terminated
PS110026 Biomet Inc. Ringloc + hybrid acetabular system Orthopedic K093235
05/06/2011 Metal Ion Levels
Consolidated
PS110094 Zimmer Rs-cup acetabular prosthesis Orthopedic K885049
05/06/2011 Metal ion levels
Terminated
PS110137 Joint Medical Products Corp. S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP Orthopedic K851421
05/06/2011 Metal ion levels
Terminated
PS110138 Joint Medical Products Corp. S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG Orthopedic K931676
05/06/2011 Metal Ion Levels
Terminated
PS110144 Synergy Orthopaedics Intl., Inc. S.A.F. Acetabular cup Orthopedic K895157
05/06/2011 Metal ion levels
Terminated
PS110101 Zimmer Schuster acetabular cup for cement/cementless fix Orthopedic K870923
05/06/2011 Metal ion levels
Terminated
PS120083 W.L. Gore & Associates, Inc. Seamguard staple line reinforcement material General &
Plastic Surgery
K955364
01/03/2012 AE and effectiveness rates
Other
PS120086 W.L. Gore & Associates, Inc. Seamguard staple line reinforcement material General &
Plastic Surgery
K010936
01/03/2012 AE and effectiveness rates
Terminated
PS110134 Endomedics, Inc. SELF-ALIGNING ACETABULAR COMPONENT Orthopedic K831792
05/06/2011 Metal ion levels
Terminated
PS120070 Shelhigh, Inc. SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. General &
Plastic Surgery
K991567
01/03/2012 AE and effectiveness rates
Terminated
PS120069 Shelhigh, Inc. Shelhigh porcine pericardial patch General &
Plastic Surgery
K021900
01/03/2012 AE and effectiveness rates
Terminated
PS100013 CareFusion Smartsite needle free valve administration sets General Hospital K061285
07/21/2010 BSI rate
Other
PS120093 Boston Scientific Corporation Solyx Single Incision Sling System General &
Plastic Surgery
K081275
01/03/2012 AE and effectiveness rates
Progress Adequate
PS090013 Ulrich Medical USA Sscs hinged screws Orthopedic K971289
K973868
K991586
10/05/2009 Fusion, AEs, Surg Procedures
Other
PS120018 Synovis Surgical Innovations / Baxter Supple peri-guard pericardium General &
Plastic Surgery
K961810
01/03/2012 AE and effectiveness rates
Terminated
PS120020 Synovis Surgical Innovations / Baxter Supple peri-guard pericardium General &
Plastic Surgery
K923657
01/03/2012 AE and effectiveness rates
Terminated
PS120057 Neomedic International SURELIFT PROLAPSE SYSTEM Obstetrics/
Gynecology
K102815
01/03/2012 AE and effectiveness rates
Other
PS120054 Mast Biosurgery USA Inc. Surgi-wrap mast bioresorbable sheet General &
Plastic Surgery
K050332
01/03/2012 AE and effectiveness rates
Terminated
PS130020 Boston Scientific Corporation Surgical fabrics General &
Plastic Surgery
K963226
03/13/2013 PSS
Other
PS130034 Prosurg, Inc. Surgical mesh w/anchoring system General &
Plastic Surgery
K070846
03/13/2013 PSS
Other
PS120109 Cook Biotech Inc. Surgisis sling Obstetrics/
Gynecology
K992159
04/09/2012 1 AE & Effectiveness Rates
2 J-PF-POST, J-SLH, J-PFV, J-PF and J-PF-ANT models
1 Terminated
2 Terminated
PS120039 Cook Biotech Inc. Surgisis staple line reinforcement General &
Plastic Surgery
K022044
01/03/2012 AE and effectiveness rates
Other
PS120105 Herniamesh SRL T-sling Obstetrics/
Gynecology
K112842
04/09/2012 AE & Effectiveness Rates
Other
PS130023 Caldera Medical Inc. T-sling Obstetrics/
Gynecology
K050516
03/13/2013 PSS
Other
PS130047 Herniamesh SRL T-Sling Obstetrics/
Gynecology
K050516
09/26/2013 PSS
Plan Pending
PS110025 Biomet Inc. Taper 2 porous femoral stem Orthopedic K050441
05/06/2011 Metal Ion Levels
Consolidated
PS120045 Ethicon, Inc. Tbd ethicon mesh (gynecare gynemesh m) General &
Plastic Surgery
K082216
01/03/2012 AE and effectiveness rates
Other
PS110145 Techmedica, Inc. TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP Orthopedic K070359
05/06/2011 Metal ion levels
Other
PS100005 ICU Medical, Inc. Tego General Hospital K040710
07/21/2010 BSI rate
Other
PS120108 Tepha, Inc. Tephaflex composite mesh General &
Plastic Surgery
K101287
04/09/2012 AE & Effectineness Rates
Terminated
PS120107 Tepha, Inc. Tephaflex surgical film General &
Plastic Surgery
K091633
04/09/2012 AE & Effectivenss Rates
Terminated
PS120079 Tepha, Inc. Tephaflex surgical mesh Obstetrics/
Gynecology
K070894
01/03/2012 AE and effectiveness rates
Terminated
PS110142 Osteotechnology, Inc. Thompson type hip prothesis Orthopedic K922868
05/06/2011 Metal ion levels
Terminated
PS120047 PFM Medical Timesh also known as timesh-tc models 6000001 & 6000004 Obstetrics/
Gynecology
K031225
01/03/2012 AE and effectiveness rates
Terminated
PS130035 TFS Surgical Tissue fixation system General &
Plastic Surgery
K050418
05/15/2013 AE and Effectiveness Rates
Plan Pending
PS120080 Tei Biosciences Inc. Tissuemend soft tissue repair matrix General &
Plastic Surgery
K020455
01/03/2012 AE and effectiveness rates
Other
PS110129 American Ortomed Corp. Titanium mittelmeier type acetabular Orthopedic K842466
05/06/2011 Metal ion levels
Terminated
PS110002 Nexus CMF Tmj fossa-eminence/condylar prosthesis system Dental P000023
P000035
02/04/2011 1 Registry Database
2 TMJ Fossa-Eminence and Condylar Pros
3 TMJM Registry Study - Total
4 TMJM Registry Study - Partial
1 Other
2 Other
3 Plan Overdue
PS130018 American Medical Systems, Inc. Topas system General &
Plastic Surgery
K070993
03/13/2013 PSS
Other
PS110058 Stryker Orthopaedics for Howmedica Osteonics Corp. Total hip, lord madreporic Orthopedic K780330
05/06/2011 Metal ion levels
Terminated
PS110004 Biomet Microfixation Total temporomandibular joint replacement system Dental P020016
02/04/2011 1 Time to Revision
2 Explant
1 Progress Adequate
2 Progress Adequate
PS090007 Globus Medical, Inc. Transition stabilization system Orthopedic K073439
10/05/2009 Fusion, AEs, Surg Procedures
Progress Inadequate
PS130036 RTI Biologics, Inc. Tutopatch General &
Plastic Surgery
K991296
03/13/2013 PSS
Terminated
PS120068 RTI Biologics, Inc. Tutopatch tutomesh General &
Plastic Surgery
K081538
01/03/2012 AE and effectiveness rates
Other
PS120072 Covidien Ugytex dual knit mesh General &
Plastic Surgery
K051503
01/03/2012 AE and effectiveness rates
Other
PS120073 Sofradim Production Ugytex mesh General &
Plastic Surgery
K033376
01/03/2012 AE and effectiveness rates
Other
PS110063 Stryker Orthopaedics for Howmedica Osteonics Corp. Uhmwpe hip and knee components - packaging change Orthopedic K964655
05/06/2011 Metal ion levels
Terminated
PS110037 Johnson and Johnson ULTIMA METAL-ON-METAL ACETABULAR CUP Orthopedic K001523
05/06/2011 Metal ion levels
Other
PS100006 B. Braun Medical Inc. Ultrasite valve General Hospital K031923
07/21/2010 BSI rate
Completed
PS110130 American Ortomed Corp. Uniloc-cementless & self tap acetabular Orthopedic K842518
05/06/2011 Metal ion levels
Terminated
PS130042 Baxter Healthcare Corp Vena Cava Filter Cardiovascular K771046
K760151
K760152
07/29/2013 PSS
Other
PS130005 Cook Incorporated Vena Cava Filter Cardiovascular K121057
K121629
K073374
K061815
02/28/2013 PSS
Other
PS130006 ALN Implants Chirurgicaux Vena cava filter Cardiovascular K070514
02/28/2013 Optional Vena Cava Filter PS study
Plan Overdue
PS130008 Rmt Medical Technologies Ltd Vena cava filter Cardiovascular K081138
02/28/2013 PSS
Other
PS130002 Boston Scientific Corporation Vena cava filters Cardiovascular K901659
K870729
K852097
K901235
02/28/2013 Greenfield PS study
Completed
PS120077 Synovis Surgical Innovations Veritas collagen matrix General &
Plastic Surgery
K062915
K030879
01/03/2012 AE and effectiveness rates
Terminated
PS120078 Synovis Surgical Innovations Veritas collagen matrix General &
Plastic Surgery
K030879
K062915
01/03/2012 AE and effectiveness rates
Terminated
PS110117 Zimmer Versys epoch fullcoat hip prosthesis, model 4088 series Orthopedic K073499
05/06/2011 Metal ion levels
Consolidated
PS110127 Advanced Bioresearch Association Weill cementless threaded acetabular cup Orthopedic K844943
05/06/2011 Metal ion levels
Terminated
PS120110 Stryker Neurovascular Wingspan stent system and gateway pta balloon catheter Neurology H050001
08/08/2012 Rates of Stroke and Death
Progress Adequate
PS120081 Tei Biosciences Inc. Xenform soft tissue repair matrix General &
Plastic Surgery
K060984
K060984
01/03/2012 1 XEN-002 Posterior
2 XEN-001 Anterior/Apical
1 Other
2 Study Pending
PS120082 Tei Biosciences Inc. Xenform soft tissue repair matrix General &
Plastic Surgery
K051190
01/03/2012 AE and effectiveness rates
Other
PS120087 Xylos Corporation Xylos porous surgical mesh General &
Plastic Surgery
K090880
01/03/2012 AE and effectiveness rates
Other
PS120088 Xylos Corporation Xylos porous surgical mesh General &
Plastic Surgery
K081882
01/03/2012 AE and effectiveness rates
Other
PS110118 Zimmer Zimmer m/l taper hip prosthesis with kinectiv technology system Orthopedic K081007
05/06/2011 1 Cross-sectional Plan
2 Prospective Study Plan
1 Consolidated
2 Terminated
PS110116 Zimmer Zimmer m/l taper hip prosthesis with kinectiv technology system, model(s) 7848 series( modular necks), 7713 series Orthopedic K071856
05/06/2011 1 Cross-sectional Plan
2 Prospective Study Plan
1 Consolidated
2 Terminated
PS110115 Zimmer Zimmer m/l taper hip prosthesis with modular neck technology Orthopedic K063251
05/06/2011 1 Cross-sectional Plan
2 Prospective Study Plan
1 Consolidated
2 Terminated
PS110112 Zimmer Zimmer mmc cup Orthopedic K091003
05/06/2011 Metal ion levels
Consolidated
PS110111 Zimmer Zimmer porolock mis stem Orthopedic K071723
05/06/2011 Metal ion levels
Consolidated
PS110114 Zimmer Zimmer threaded acetabular cup Orthopedic K850766
05/06/2011 Metal ion levels
Terminated
PS090016 Zimmer Spine Zimmer® dynesys® spinal system with dto implant Orthopedic K031511
K071879
K071880
10/05/2009 Fusion, AEs, Surg Procedures
Progress Inadequate
PS090017 Zimmer Spine Zimmer® dynesys® top-loading spinal system Orthopedic K073347
10/05/2009 Fusion, AEs, Surg Procedures
Consolidated
PS130033 Prosurg, Inc. Zippere- bioabsorbable/non-absorbable polymer sling & surgical mesh General &
Plastic Surgery
K030631
03/13/2013 AE and Effectiveness Rates
Other
PS090002 Alphatec Spine Zodiac dynamo semi-rigid spinal system Orthopedic K072081
10/05/2009 Fusion, AEs, Surg Procedures
Other
PS110093 Zimmer Zweymueller-sl hip prosthesis stem Orthopedic K871453
05/06/2011 1 Cross-Sectional Study
2 Prospective Study Plan
3 Explant Analysis
1 Progress Inadequate
2 Terminated
3 Progress Inadequate
PS110092 Zimmer Zweymuller cup Orthopedic K851213
05/06/2011 Metal ion levels
Terminated

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