|
|
522 Order Number |
|
|
|
Manufacturer |
|
|
|
Device Name |
|
|
|
Medical Specialty |
|
|
|
Date 522 Order |
|
|
|
|
PS120001
|
Acell, Inc. |
Acell matristem pelvic floor matrix |
General & Plastic Surgery |
01/03/2012 |
POP AE and Effectiveness rates, registry
|
Completed |
PS110124
|
Advanced Bioresearch Association |
Natural lock acetabular component |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110125
|
Advanced Bioresearch Association |
Muller titanium backed acetabular cup component |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110126
|
Advanced Bioresearch Association |
Pm cementless screw-in acetabular cup |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110127
|
Advanced Bioresearch Association |
Weill cementless threaded acetabular cup |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110128
|
Advanced Bioresearch Association |
Freeman acetabular cup |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS130043
|
Aesculap, Inc. |
Ring upm total hip replacement |
Orthopedic |
07/29/2013 |
PSS
|
Terminated |
PS130045
|
Aesculap, Inc. |
Modular range of ring pros. For hip replacement |
Orthopedic |
07/29/2013 |
PSS
|
Terminated |
PS090002
|
Alphatec Spine |
Zodiac dynamo semi-rigid spinal system |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS090012
|
Alphatec Spine |
Isobar semi-rigid spinal system & dual dampener |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS120002
|
American Medical Systems, Inc. |
Ams large pore polypropylene mesh |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120003
|
American Medical Systems, Inc. |
Ams large pore polypropylene mesh |
Obstetrics/ Gynecology |
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 |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120007
|
American Medical Systems, Inc. |
Ams elevate apical and posterior prolapse repair system with intepro lite or intexen lp |
Obstetrics/ Gynecology |
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 |
01/03/2012 |
AE and Effectiveness Rates
|
Other |
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 |
Obstetrics/ Gynecology |
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 |
Obstetrics/ Gynecology |
01/03/2012 |
Apogee AE and Eff Rates
|
Other |
Perigee AE and Eff Rates
|
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 |
Obstetrics/ Gynecology |
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 |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120013
|
American Medical Systems, Inc. |
Apogee and perigee systems with pc coated intepro lite |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120014
|
American Medical Systems, Inc. |
Elevate prolapse repair system with pc coated intepro lite- apical and posterior prolapse repair system anterior and ap |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
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 |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120090
|
American Medical Systems, Inc. |
Miniarc precise single-incision sling system |
Gastroenterology/ Urology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120091
|
American Medical Systems, Inc. |
Miniarc precise single-incision sling system |
Gastroenterology/ Urology |
01/03/2012 |
SUI AE and Effectiveness rates
|
Consolidated |
PS120092
|
American Medical Systems, Inc. |
Miniarc precise single-incision sling system |
Gastroenterology/ Urology |
01/03/2012 |
SUI AE and Effectiveness rates
|
Consolidated |
PS130011
|
American Medical Systems, Inc. |
Elevate prolapse repair systems |
Obstetrics/ Gynecology |
03/13/2013 |
AE & Effectiveness Rates
|
Consolidated |
PS130017
|
American Medical Systems, Inc. |
Ams triangle silicone-coated sling and surgical mesh |
General & Plastic Surgery |
03/13/2013 |
PSS
|
Other |
PS130018
|
American Medical Systems, Inc. |
Topas system |
General & Plastic Surgery |
03/13/2013 |
PSS
|
Other |
PS130019
|
American Medical Systems, Inc. |
Pfr sling system, (part of the pelvic floor repair system) |
General & Plastic Surgery |
03/13/2013 |
PSS
|
Other |
PS130037
|
American Medical Systems, Inc. |
Miniarc pro single-incision sling system |
Gastroenterology/ Urology |
03/13/2013 |
PSS
|
Consolidated |
PS110129
|
American Ortomed Corp. |
Titanium mittelmeier type acetabular |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110130
|
American Ortomed Corp. |
Uniloc-cementless & self tap acetabular |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS100002
|
Amsino International, Inc |
Cortez needle free iv connector |
General Hospital |
07/21/2010 |
BSI rate
|
Other |
PS090003
|
Applied Spine Technologies, Inc. |
Bar pedicle screw spinal fixation system |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS140001
|
Argo Medical Technologies, Inc |
Rewalk |
Neurology |
06/26/2014 |
ReWalk RWE Study
|
Completed |
PS120004
|
Astora Womens Health |
Ams elevate anterior & apical prolapse repair system with intepro llite |
Obstetrics/ Gynecology |
01/03/2012 |
POP AE and effectiveness rates, registry
|
Other |
PS120006
|
Astora Womens Health |
Ams elevate apical and posterior prolapse repair system with intepro lite |
Obstetrics/ Gynecology |
01/03/2012 |
POP AE and Effectiveness rates, registry
|
Other |
Elevate System w/InteXen LP
|
Other |
PS120089
|
Astora Womens Health |
Miniarc precise single-incision sling system |
Gastroenterology/ Urology |
01/03/2012 |
SUI AE and Effectiveness rates
|
Other |
PS180001
|
Avenu Medical, Inc. |
Ellipsys vascular access system |
Cardiovascular |
06/21/2018 |
Postmarket Study
|
Other |
PS100006
|
B. Braun Medical Inc. |
Ultrasite valve |
General Hospital |
07/21/2010 |
BSI rate
|
Completed |
PS140002
|
Bard Peripheral Perivascular |
Simon Nitinol System |
Cardiovascular |
10/17/2014 |
Simon Nitinol PS
|
Other |
PS130042
|
Baxter Healthcare Corp |
Vena Cava Filter |
Cardiovascular |
07/29/2013 |
PSS
|
Other |
PS100007
|
Baxter Healthcare Corporation |
Iv/catheter extension set with nac plus needleless access connector and nac plus needleless access connector |
General Hospital |
07/21/2010 |
BSI rate
|
Other |
PS100008
|
Becton Dickinson Infusion Therapy Systems |
Bd posiflow/tm positive displacement valve |
General Hospital |
07/21/2010 |
BSI rate
|
Other |
PS100011
|
Becton Dickinson Infusion Therapy Systems |
Nima needleless injectionsite master adapter with posiflow positive displacement feature, and iv sets |
General Hospital |
07/21/2010 |
BSI rate
|
Other |
PS110005
|
Biomet Inc. |
Porous titanium acetabular augments, m2a magnum 12/14 taper inserts and one-piece modular heads |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Completed |
Explant Analysis
|
Completed |
PS110006
|
Biomet Inc. |
M2a magnum 12/14 taper inserts and one-piece modular heads |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110007
|
Biomet Inc. |
Lateralized taperloc microplasty femoral components |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110008
|
Biomet Inc. |
M2a-magnum tri-spike acetabular component |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110009
|
Biomet Inc. |
Altra press-fit hip system |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110010
|
Biomet Inc. |
Altra fx hip system |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110011
|
Biomet Inc. |
Echo bi-metric press-fit stems |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110012
|
Biomet Inc. |
Parallel-sided extensively coated femoral stems |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110013
|
Biomet Inc. |
Compress segmental femoral replacement system (short spindle and anchor plug) |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110014
|
Biomet Inc. |
Metal on metal acetabular system |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110015
|
Biomet Inc. |
M2a 28mm ringloc liner |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110016
|
Biomet Inc. |
M2a acetabular system |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110017
|
Biomet Inc. |
M2a magnum system |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110018
|
Biomet Inc. |
Mallory-head modular calcar stems with interlocking slots |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110019
|
Biomet Inc. |
M2a/c2a acetabular system |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110020
|
Biomet Inc. |
Porous coated acetabular components |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110021
|
Biomet Inc. |
Compress segmental femoral replacement system |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110022
|
Biomet Inc. |
Biomet metal-on-metal hip systems- expanded contraindications |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110023
|
Biomet Inc. |
Biomet modular femoral revision system |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110024
|
Biomet Inc. |
Balance hip system |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110025
|
Biomet Inc. |
Taper 2 porous femoral stem |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110026
|
Biomet Inc. |
Ringloc + hybrid acetabular system |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Consolidated |
PS110004
|
Biomet Microfixation |
Total temporomandibular joint replacement system |
Dental |
02/04/2011 |
Time to Revision
|
Completed |
Explant
|
Completed |
PS090004
|
Biospine Co., Ltd. |
Bioflex® |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS120081
|
Boston Scientific |
Xenform soft tissue repair matrix |
General & Plastic Surgery |
01/03/2012 |
POP AE and Effectiveness rates, registry
|
Completed |
PS120021
|
Boston Scientific Corporation |
Lite pelvic floor repair kits |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates for Uphold LITE
|
Other |
DUET LITE
|
Other |
Posterior LITE
|
Other |
Anterior LITE
|
Other |
PS120022
|
Boston Scientific Corporation |
Pelvic floor repair system (pinnacle duet) |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates-Duet
|
Other |
PS120023
|
Boston Scientific Corporation |
Pinnacle pelvic floor repair kit ii (uphold) |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates-Uphold
|
Other |
PS120024
|
Boston Scientific Corporation |
Pinnacle pelvic floor repair kits (pinnacle) |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates-Anterior
|
Other |
Posterior
|
Other |
PS120093
|
Boston Scientific Corporation |
Solyx Single Incision Sling System |
Gastroenterology/ Urology |
01/03/2012 |
SUI AE and Effectiveness rates
|
Completed |
PS130001
|
Boston Scientific Corporation |
Greenfield vena cava filters |
Cardiovascular |
02/28/2013 |
Greenfield PS study
|
Completed |
PS130002
|
Boston Scientific Corporation |
Vena cava filters |
Cardiovascular |
02/28/2013 |
Greenfield PS study
|
Completed |
PS130020
|
Boston Scientific Corporation |
Surgical fabrics |
General & Plastic Surgery |
03/13/2013 |
PSS
|
Other |
PS130021
|
Boston Scientific Corporation |
Modification to trelex mesh surgical mesh |
Gastroenterology/ Urology |
03/13/2013 |
PSS
|
Terminated |
PS130022
|
Boston Scientific Corporation |
Modification to Surgical Mesh Polymeric |
Gastroenterology/ Urology |
03/13/2013 |
PSS
|
Terminated |
PS130044
|
Boston Scientific Corporation |
Pinnacle LITE Pelvic Floor Repair Kits - Uphold Lite Posterior and Uphold |
Obstetrics/ Gynecology |
07/03/2013 |
POP AE and Effectiveness rates, registry
|
Completed |
Posterior Lite
|
Other |
PS110131
|
C.R. Bard Inc. |
CONTOUR II LINK SP TOTAL HIP PROSTHESIS |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS120027
|
C.R. Bard Inc. |
Avaulta solo synthetic support system avaulta plus biosynthetic support system; Avaulta support system |
Obstetrics/ Gynecology |
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 |
Obstetrics/ Gynecology |
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 |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120030
|
C.R. Bard Inc. |
Bard prolapse repair system |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120031
|
C.R. Bard Inc. |
Bard pelvisoft acellular collagen biomesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120094
|
C.R. Bard Inc. |
Ajust adjustable single incision sling |
Gastroenterology/ Urology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS130038
|
C.R. Bard Inc. |
Ajust helical adjustable single-incision sling |
Gastroenterology/ Urology |
03/13/2013 |
PSS
|
Other |
PS120032
|
Caldera Medical Inc. |
Popmesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates-PoP Mesh
|
Other |
PS120033
|
Caldera Medical Inc. |
Ascend blue ac mesh; Ascend blue pc mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120034
|
Caldera Medical Inc. |
Ascend blue ac mesh; Ascend blue pc mesh |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120102
|
Caldera Medical Inc. |
Desara mini |
Gastroenterology/ Urology |
04/09/2012 |
AE & Effectiveness Rates
|
Other |
PS130023
|
Caldera Medical Inc. |
T-sling |
Gastroenterology/ Urology |
03/13/2013 |
PSS
|
Terminated |
PS130024
|
Caldera Medical Inc. |
Caldera mesh |
General & Plastic Surgery |
03/13/2013 |
PSS
|
Other |
PS130025
|
Caldera Medical Inc. |
Desara mesh sling, model cal-dsol |
Gastroenterology/ Urology |
03/13/2013 |
PSS
|
Terminated |
PS130026
|
Caldera Medical Inc. |
Desara mesh |
Gastroenterology/ Urology |
03/13/2013 |
PSS
|
Terminated |
PS130027
|
Caldera Medical Inc. |
Desara mesh |
Gastroenterology/ Urology |
03/13/2013 |
PSS
|
Terminated |
PS060003
|
Cardica, Inc. |
C-port distal anastomosis system |
General & Plastic Surgery |
06/14/2006 |
Graft Patency and Technical Failure
|
Completed |
PS100009
|
CareFusion |
Maxplus tru-swab positive displacement connector |
General Hospital |
07/21/2010 |
BSI rate
|
Completed |
PS100010
|
CareFusion |
Maxplus tru-swab positive displacement connector |
General Hospital |
07/21/2010 |
BSI rate
|
Completed |
PS100012
|
CareFusion |
Ivac needle free administration sets |
General Hospital |
07/21/2010 |
BSI rate
|
Other |
PS100013
|
CareFusion |
Smartsite needle free valve administration sets |
General Hospital |
07/21/2010 |
BSI rate
|
Other |
PS120035
|
Coloplast Corp |
Exair anterior and posterior prolapse repair systems |
Obstetrics/ Gynecology |
01/03/2012 |
POP AE and Effectiveness rates, registry
|
Other |
PS120036
|
Coloplast Corp |
Exair anterior and posterior prolapse repair systems |
Obstetrics/ Gynecology |
01/03/2012 |
POP AE and Effectiveness rates, registry
|
Consolidated |
PS120037
|
Coloplast Corp |
Mentor novasilk mesh |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120038
|
Coloplast Corp |
Restorelle polypropylene mesh; Restorelle polypropylene mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
Restorelle P, EZA, EZP, and L models
|
Other |
PS120055
|
Coloplast Corp |
Minimesh polypropylene mesh |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
Restorelle P, EZA and L model
|
Other |
PS120056
|
Coloplast Corp |
Minimesh polypropylene mesh |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
Restorelle P, EZA and L models
|
Other |
PS120096
|
Coloplast Corp |
Gyne ideas minitape rp device |
Gastroenterology/ Urology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120097
|
Coloplast Corp |
Minitape urethral sling |
Gastroenterology/ Urology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120098
|
Coloplast Corp |
Minitape urethral sling |
Gastroenterology/ Urology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS130012
|
Coloplast Corp |
Mentor suspend sling |
General & Plastic Surgery |
03/13/2013 |
PSS
|
Other |
PS130030
|
Coloplast Corp |
Mentor suspend sling |
General & Plastic Surgery |
03/13/2013 |
PSS
|
Other |
PS130039
|
Coloplast Corp |
Altis single incision sling system |
Gastroenterology/ Urology |
03/13/2013 |
AE and effectiveness rates
|
Completed |
PS120106
|
Coloplast Corp. |
Restorelle polypropylene mesh |
General & Plastic Surgery |
04/09/2012 |
POP AE and Effectiveness rates, registry
|
Completed |
Restorelle P, EZA, EZP, and L models
|
Other |
PS120039
|
Cook Biotech Inc. |
Surgisis staple line reinforcement |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120109
|
Cook Biotech Inc. |
Surgisis sling |
General & Plastic Surgery |
04/09/2012 |
AE & Effectiveness Rates
|
Terminated |
J-PF-POST, J-SLH, J-PFV, J-PF and J-PF-ANT models
|
Terminated |
PS130040
|
Cook Biotech Inc. |
Biodesign® Surgisis® Anterior and Posterior Pelvic Floor Grafts |
Obstetrics/ Gynecology |
06/17/2013 |
AE and Effectiveness Rates
|
Other |
PS130005
|
Cook Incorporated |
Vena Cava Filter |
Cardiovascular |
02/28/2013 |
Celect IVC Filter
|
Completed |
PS120040
|
Cousin Biotech SARL |
Biotech SAS for Biomesh® Pl and Biomesh® Plug and Patch |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120071
|
Covidien |
Parietene duo and quadra polypropylene meshes |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120072
|
Covidien |
Ugytex dual knit mesh |
Obstetrics/ Gynecology |
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 |
Obstetrics/ Gynecology |
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 |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS130028
|
Covidien |
Ivs tunneller |
General & Plastic Surgery |
03/13/2013 |
PSS
|
Other |
PS130029
|
Covidien |
Ivs tunneller devices |
General & Plastic Surgery |
03/13/2013 |
PSS
|
Other |
PS120041
|
CryoLife, Inc. |
Propatch soft tissue repair matrix |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120042
|
CryoLife, Inc. |
Propatch soft tissue repair matrix |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120052
|
Cytori Therapeutics, Inc. |
Macropore surgiwrap (ts) |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS110149
|
Depuy Orthopaedics, Inc. |
Depuy corail hip system, revision stem |
Orthopedic |
05/06/2011 |
PSS
|
Terminated |
PS090005
|
DePuy Spine |
6.35mm and 5.5mm peek rods |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS130015
|
DIMA |
Contasure Needleless sling |
Gastroenterology/ Urology |
03/13/2013 |
AE and Effectiveness Rates
|
Completed |
PS110029
|
DJO Global |
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 |
05/06/2011 |
Clinical Study
|
Completed |
Device Retrieval Study
|
Completed |
PS110132
|
Downs Surgical Ltd. |
RING UPM TOTAL HIP REPLACEMENT |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110133
|
Downs Surgical Ltd. |
MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS120048
|
DSM Biomedical |
Bioblanket surgical mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120049
|
DSM Biomedical |
Bioblanket surgical mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120050
|
DSM Biomedical |
Medeor matrix models 30010-xx (hydrated); 30020-xx (dry) |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120051
|
DSM Biomedical |
Kensey nash ecm surgical patch |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS110030
|
Encore Medical |
Metal/metal hip system |
Orthopedic |
05/06/2011 |
Clinical Study
|
Consolidated |
Device Retrieval Study
|
Consolidated |
PS110031
|
Encore Medical |
Modification to: Fmp metal/metal acetabular insert, models 499-28, 499-34, 499-38 |
Orthopedic |
05/06/2011 |
Clinical Study
|
Consolidated |
Device Retrieval Study
|
Consolidated |
PS110032
|
Encore Medical |
Fmp metal/metal acetabular insert, 499-28,449-34, 499-38 |
Orthopedic |
05/06/2011 |
Clinical Study
|
Consolidated |
Device Retrieval Study
|
Consolidated |
PS110033
|
Encore Medical |
Revelation stem, model 427-21/42-080/180 |
Orthopedic |
05/06/2011 |
Clinical Study
|
Consolidated |
Device Retrieval Study
|
Consolidated |
PS110034
|
Encore Medical |
Djo surgical revision femoral hip system, model 428-14/24-140/200; 428-00-050/110 |
Orthopedic |
05/06/2011 |
Clinical Study
|
Consolidated |
Device Retrieval Study
|
Consolidated |
PS110035
|
Encore Medical |
Metal backed acetabular component |
Orthopedic |
05/06/2011 |
Clinical Study
|
Consolidated |
Device Retrieval Study
|
Consolidated |
PS110036
|
Encore Medical |
Fmp metal/metal acetabular insert |
Orthopedic |
05/06/2011 |
Clinical Study
|
Consolidated |
Device Retrieval Study
|
Consolidated |
PS110134
|
Endomedics, Inc. |
SELF-ALIGNING ACETABULAR COMPONENT |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS120043
|
Ethicon, Inc. |
Gynecare prolift +m* pelvic floor repair systems |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120044
|
Ethicon, Inc. |
Gynecare prosima pelvic floor repair systems |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120045
|
Ethicon, Inc. |
Tbd ethicon mesh (gynecare gynemesh m) |
General & Plastic Surgery |
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 |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120095
|
Ethicon, Inc. |
Gynecare tvt secur system |
Gastroenterology/ Urology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS090015
|
Exactech, Inc. |
Modified vertiflex spinal screw system (with dynabolt rods) |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS150002
|
Fujifilm Medical Systems USA, Inc. |
Fujifilm duodenoscopes |
Gastroenterology/ Urology |
10/05/2015 |
Human Factors Study
|
Completed |
Sampling and Culturing Study
|
Terminated |
PS190002
|
FUJIFILM Medical Systems, U.S.A., Inc. |
Duodenoscope |
Gastroenterology/ Urology |
08/28/2019 |
Sampling and Culturing
|
Completed |
PS140004
|
Genzyme Sanofi |
GlucaMesh and Glucatex (Polypropylene/Polyester) Mesh |
General & Plastic Surgery |
12/11/2014 |
PSS
|
Other |
PS090006
|
Globus Medical, Inc. |
Protex rods |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS090007
|
Globus Medical, Inc. |
Transition stabilization system |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS130041
|
Halt Medical Inc. |
Acessa system |
Obstetrics/ Gynecology |
06/17/2013 |
Newly Enrolled
|
Completed |
(IDE) Long Term Follow-up
|
Completed |
PS120053
|
Herniamesh SRL |
Pelvimesh / hermesh 7 |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120104
|
Herniamesh SRL |
Biosling Bioabsorbable Polymer Sling & Surgical Mesh |
Gastroenterology/ Urology |
04/09/2012 |
AE & Effectiveness Rates
|
Terminated |
PS120105
|
Herniamesh SRL |
T-sling |
Obstetrics/ Gynecology |
04/09/2012 |
AE & Effectiveness Rates
|
Other |
PS130013
|
Herniamesh SRL |
Hemiamesh t-sling |
Gastroenterology/ Urology |
03/13/2013 |
PSS
|
Terminated |
PS130047
|
Herniamesh SRL |
T-Sling |
Gastroenterology/ Urology |
09/26/2013 |
PSS
|
Terminated |
PS120100
|
IBI Israel Biomedical Innovations |
EndoFast Reliant¿. |
General & Plastic Surgery |
04/09/2012 |
AE and Effectiveness Rates
|
Other |
PS120101
|
IBI Israel Biomedical Innovations |
Endofast reliant¿. |
General & Plastic Surgery |
04/09/2012 |
AE & Effectiveness Rates
|
Other |
PS100003
|
ICU Medical, Inc. |
Clc2000 |
General Hospital |
07/21/2010 |
BSI rate
|
Other |
PS100004
|
ICU Medical, Inc. |
Clc2000 catheter patency device |
General Hospital |
07/21/2010 |
BSI rate
|
Other |
PS100005
|
ICU Medical, Inc. |
Tego |
General Hospital |
07/21/2010 |
BSI rate
|
Other |
PS110135
|
Implantology LLC |
Cps acetabular component |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Other |
PS110136
|
Implantology LLC |
Fpc/sfpc/rfpc acetabular component |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Other |
PS120103
|
Injectx, Inc |
Biosling bioabsorbable polymer sling & surgical mesh |
General & Plastic Surgery |
04/09/2012 |
Postmarket Surveillance Study
|
Other |
PS110037
|
Johnson and Johnson |
ULTIMA METAL-ON-METAL ACETABULAR CUP |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Other |
PS110038
|
Johnson and Johnson |
Depuy pinnacle metal-on-metal acetabular cup liners |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Completed |
Explant Analysis
|
Completed |
PS110039
|
Johnson and Johnson |
Pinnacle metal-on-metal acetabular cup liners |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110040
|
Johnson and Johnson |
Depuy pinnacle metal-on-metal acetabular cup liner |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110041
|
Johnson and Johnson |
Depuy asr modular acetabular cup system |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110042
|
Johnson and Johnson |
Corail amt hip prosthesis |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110043
|
Johnson and Johnson |
Dupuy s-rom std hip stem prosthesis |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110044
|
Johnson and Johnson |
Depuy pinnacle metal-on-metal acetabular cup liners |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110045
|
Johnson and Johnson |
Depuy asr taper sleeve adapter |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110046
|
Johnson and Johnson |
Depuy corail amt dysplasia hip prosthesis |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110047
|
Johnson and Johnson |
Depuy tri-lock bone preservation stem |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110048
|
Johnson and Johnson |
Depuy asr xl modular acetabular cup system |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110049
|
Johnson and Johnson |
Depuy asr 300 acetabular cup system |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110050
|
Johnson and Johnson |
Depuy asphere m-spec head |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110051
|
Johnson and Johnson |
Depuy c-stem amt |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110052
|
Johnson and Johnson |
Depuy pinnacle metal-on-metal acetabular cup liners |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110053
|
Johnson and Johnson |
Depuy pinnacle 100 with gription acetabular cups |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110054
|
Johnson and Johnson |
Depuy pinnacle with gription acetabular cups |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
Explant Analysis
|
Consolidated |
PS110055
|
Johnson and Johnson |
PROFILE FEMORAL HIP |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110137
|
Joint Medical Products Corp. |
S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110138
|
Joint Medical Products Corp. |
S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG |
Orthopedic |
05/06/2011 |
Metal Ion Levels
|
Terminated |
PS110119
|
Link America, Inc. |
Lidgrer-lund acetabular sockets |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110120
|
Link America, Inc. |
Link metal-backed acetabular cups |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110139
|
Med-Tek Corp. |
H.N. Metal backed acetabular cup, noncemented |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS090008
|
Medtronic |
Cd horizon® peek rods |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS090009
|
Medtronic Sofamor Danek |
Cd horizon® agile¿ dynamic stabilization device |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS010001
|
Medtronic Vascular |
Aneurx stent graft system |
Cardiovascular |
06/13/2001 |
AneuRx Stent Graft System
|
Completed |
PS110070
|
MicroPort |
Metal transcend articulation system |
Orthopedic |
05/06/2011 |
Metal Ion Levels Microport
|
Completed |
Explant
|
Completed |
PS110071
|
MicroPort |
Metal transcend articulation system |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110072
|
MicroPort |
Metal transcend articulation system (larger sizes) |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110073
|
MicroPort |
Conserve plus spiked acetabular shells and conserve total 56mm femoral head |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110074
|
MicroPort |
Profemur s hip stem |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110075
|
MicroPort |
Conserve plus revision shell and conserve plus thick shell |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110076
|
MicroPort |
Profemur tapered hip stem |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110077
|
MicroPort |
Procotyl-e acetabular system |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110078
|
MicroPort |
Lineage ha acetabular shells |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110079
|
MicroPort |
Conserve plus ha acetabular shells |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110080
|
MicroPort |
Profemur renaissance hip stem |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110081
|
MicroPort |
Conserve total femoral head |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110082
|
MicroPort |
Profemur xtr hip stem |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110083
|
MicroPort |
Profemur lx hip stem |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110084
|
MicroPort |
Conserve plus quadrafix acetabular shell |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110085
|
MicroPort |
Profemur tl hip stem |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110086
|
MicroPort |
Dynasty acetabular shell and cocr acetabular liner |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110087
|
MicroPort |
Dynasty acetabular system |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110088
|
MicroPort |
Profemur lx revision 5/8 coated hip stem |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110089
|
MicroPort |
Profemur lx 5/8 coated hip stem |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110090
|
MicroPort |
Dynasty porous acetabular shell, dynasty polyethylene acetabular liner, dynasty metal acetabular liner |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110091
|
MicroPort |
Profemur hip system modular necks |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110148
|
MicroPort |
Conserve bio foam shell |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS130010
|
MicroPort |
Link metal-backed acetabular cups |
Orthopedic |
03/20/2013 |
PSS
|
Terminated |
PS100001
|
MicroVention, Inc. |
Microvention hydrocoil-soft-frame |
Neurology |
04/15/2010 |
HydroCoil Study
|
Completed |
HydroSoft/HydroFrame Study
|
Completed |
PS120057
|
Neomedic International |
SURELIFT PROLAPSE SYSTEM |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS110002
|
Nexus CMF |
Tmj fossa-eminence/condylar prosthesis system |
Dental |
02/04/2011 |
TMJ Fossa-Eminence and Condylar Pros
|
Other |
TMJ Registry Study - Total
|
Other |
PS200002
|
Olympus America, Inc. |
Evis exera iii duodenovideoscope tjf-q190v |
Gastroenterology/ Urology |
01/17/2020 |
Human Factors Study
|
Completed |
PS150003
|
Olympus Medical Systems Corporation (OMSC. |
Duodenoscopes |
Gastroenterology/ Urology |
10/05/2015 |
Human Factors Study
|
Completed |
Sampling and Culturing Study
|
Completed |
PS120058
|
Organogenesis, Inc. |
FORTAFLEX SURGICAL MESH |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120059
|
Organogenesis, Inc. |
FORTAFLEX SURGICAL MESH |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120060
|
Organogenesis, Inc. |
FORTAFLEX SURGICAL MESH |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS130031
|
Organogenesis, Inc. |
Fortaflex surgical sling |
General & Plastic Surgery |
03/13/2013 |
PSS
|
Other |
PS130032
|
Organogenesis, Inc. |
FortaPerm surgical sling |
General & Plastic Surgery |
03/13/2013 |
PSS
|
Other |
PS110140
|
Orthopaedic Device Corp. |
P.T.H. METAL-BACKED ACETABULAR CUP |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110123
|
Orthopedic Manufacturing Co. |
Ace 100 degrees tubular plate |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110141
|
Osteotechnology, Inc. |
Biometric screw fixation cup |
Orthopedic |
05/06/2011 |
PSS
|
Terminated |
PS110142
|
Osteotechnology, Inc. |
Thompson type hip prothesis |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS200007
|
Outset Medical Inc. |
Tablo hemodialysis system |
Gastroenterology/ Urology |
06/12/2020 |
Human Factors Study
|
Other |
PS090011
|
Paradigm Spine |
Dss stabilization system |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS160003
|
Parker Hannifin Corporation |
Indego |
Neurology |
04/15/2016 |
Indego Postmarket Surveillance Study
|
Completed |
PS150004
|
Pentax Medical |
Duodenoscopes |
Gastroenterology/ Urology |
10/05/2015 |
Human Factors Study
|
Completed |
Sampling and Culturing Study
|
Completed |
PS190003
|
Pentax of America, Inc. |
Duodenoscope |
Gastroenterology/ Urology |
08/28/2019 |
Human Factors Study
|
Other |
PS190004
|
Pentax of America, Inc. |
Duodenoscope |
Gastroenterology/ Urology |
08/28/2019 |
Sampling and Culturing
|
Other |
PS120047
|
PFM Medical |
Timesh also known as timesh-tc models 6000001 & 6000004 |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS060001
|
Philips Medical Systems, Heartstream |
Philips heartstart home otc defibrillator |
Cardiovascular |
12/07/2005 |
Non-Prescription Use
|
Completed |
PS150001
|
Preceptis |
Hummingbird tympanostomy tube system |
Ear Nose & Throat |
04/23/2015 |
Post-market Surveillance Study (PSS)
|
Completed |
PS130016
|
Promedon |
Ophira mini sling system |
Gastroenterology/ Urology |
03/13/2013 |
PSS
|
Terminated |
PS120066
|
Promethean Surgical Devices, Inc. |
Hydrocoat mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120099
|
Prosurg, Inc. |
Minisling adjustable polymer sling & surgical mesh with self-anchoring system (easy lift prolapse repair & minisling) |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS130033
|
Prosurg, Inc. |
Zippere- bioabsorbable/non-absorbable polymer sling & surgical mesh |
General & Plastic Surgery |
03/13/2013 |
AE and Effectiveness Rates
|
Other |
PS130034
|
Prosurg, Inc. |
Surgical mesh w/anchoring system |
General & Plastic Surgery |
03/13/2013 |
PSS
|
Other |
PS120067
|
Proxy Biomedical Ltd. |
Polyform synthetic mesh |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS130008
|
Rmt Medical Technologies Ltd |
Vena cava filter |
Cardiovascular |
02/28/2013 |
PSS
|
Other |
PS120068
|
RTI Biologics, Inc. |
Tutopatch tutomesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS130036
|
RTI Biologics, Inc. |
Tutopatch |
General & Plastic Surgery |
03/13/2013 |
PSS
|
Terminated |
PS120069
|
Shelhigh, Inc. |
Shelhigh porcine pericardial patch |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120070
|
Shelhigh, Inc. |
SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH. |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
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 |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120061
|
Smith & Nephew, Inc |
Immix plastifilm |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120073
|
Sofradim Production |
Ugytex mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120074
|
Sofradim Production |
Parietex |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120111
|
St. Jude Medical, Inc. |
Riata, quicksite, quickflex, durata |
Cardiovascular |
08/16/2012 |
Lead Externalization and Abrasion
|
Completed |
PS130046
|
St. Jude Medical, Inc. |
Amplatzer |
Cardiovascular |
09/13/2013 |
ADVANCE ASO
|
Completed |
PS120025
|
Stellen Medical |
Brennen medical surgical mesh glucamesh/glucatex |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120026
|
Stellen Medical |
Dermmatrix surgical mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120110
|
Stryker Neurovascular |
Wingspan stent system and gateway pta balloon catheter |
Neurology |
08/08/2012 |
Rates of Stroke and Death
|
Completed |
PS110144
|
Synergy Orthopaedics Intl., Inc. |
S.A.F. Acetabular cup |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS120063
|
Synovis Surgical Innovation |
Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120064
|
Synovis Surgical Innovation |
Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120017
|
Synovis Surgical Innovations |
Peri-strips |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120065
|
Synovis Surgical Innovations |
Orthadapt pr; Orthadapt bioimplant; Pegasus biologics orthadapt surgical mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120077
|
Synovis Surgical Innovations |
Veritas collagen matrix |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120078
|
Synovis Surgical Innovations |
Veritas collagen matrix |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
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 |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120018
|
Synovis Surgical Innovations / Baxter |
Supple peri-guard pericardium |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120019
|
Synovis Surgical Innovations / Baxter |
Peri-guard pericardium |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120020
|
Synovis Surgical Innovations / Baxter |
Supple peri-guard pericardium |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS090010
|
Synthes Spine |
Ngarde system |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS090001
|
Szabocsik and Associates |
Jsz orthokeratology contact lenses for overnight wear |
Ophthalmic |
08/07/2009 |
Microbial Keratitis
|
Other |
PS190006
|
Tandem Diabetes Co. |
Control-iq, algorithm |
Clinical Chemistry |
12/13/2019 |
Postmarket Surveillance Study
|
Completed |
PS200008
|
Tandem Diabetes Co. |
Control-iq technology |
Clinical Chemistry |
06/23/2020 |
Postmarket Surveillance
|
Completed |
PS110145
|
Techmedica, Inc. |
TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS120080
|
Tei Biosciences Inc. |
Tissuemend soft tissue repair matrix |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120082
|
Tei Biosciences Inc. |
Xenform soft tissue repair matrix |
Obstetrics/ Gynecology |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120079
|
Tepha, Inc. |
Tephaflex surgical mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120107
|
Tepha, Inc. |
Tephaflex surgical film |
General & Plastic Surgery |
04/09/2012 |
AE & Effectivenss Rates
|
Terminated |
PS120108
|
Tepha, Inc. |
Tephaflex composite mesh |
General & Plastic Surgery |
04/09/2012 |
AE & Effectineness Rates
|
Terminated |
PS130035
|
TFS Surgical |
Tissue fixation system |
General & Plastic Surgery |
05/15/2013 |
AE and Effectiveness Rates
|
Other |
PS060002
|
The Ohio State University |
Paragon crt 100 lens and boston vision shaping treatment (vst) lens for ook |
Ophthalmic |
05/25/2006 |
Microbial Keratitis Study
|
Completed |
PS110146
|
Turnkey Intergration USA, Inc. |
Modified freeman acetabular cup |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110147
|
Turnkey Intergration USA, Inc. |
Modified freeman revision acetabular cup |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS090013
|
Ulrich Medical USA |
Sscs hinged screws |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS090014
|
Ulrich Medical USA |
Cosmic system |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS110001
|
Vermillion, Inc |
Ova1 |
Immunology |
01/31/2011 |
OVA1 Performance in Pre and Post Menopausal Women
|
Completed |
PS120083
|
W.L. Gore & Associates, Inc. |
Seamguard staple line reinforcement material |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120084
|
W.L. Gore & Associates, Inc. |
Modification to seamguard staple line reinforcement material |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120085
|
W.L. Gore & Associates, Inc. |
Gore bioabsorbable mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS120086
|
W.L. Gore & Associates, Inc. |
Seamguard staple line reinforcement material |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Terminated |
PS110121
|
Waldemar Link GMBH & Co. KG |
Link cementless screw-in acetabular cup |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110122
|
Waldemar Link GMBH & Co. KG |
Link cementless screw-in acetabular cup |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS130009
|
Wright Medical Technology, Inc. |
Linked metal-backed acetabular cups |
Orthopedic |
03/20/2013 |
PSS
|
Other |
PS120087
|
Xylos Corporation |
Xylos porous surgical mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS120088
|
Xylos Corporation |
Xylos porous surgical mesh |
General & Plastic Surgery |
01/03/2012 |
AE and effectiveness rates
|
Other |
PS110092
|
Zimmer |
Zweymuller cup |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110093
|
Zimmer |
Zweymueller-sl hip prosthesis stem |
Orthopedic |
05/06/2011 |
Cross-Sectional Study
|
Completed |
Explant Analysis
|
Completed |
PS110094
|
Zimmer |
Rs-cup acetabular prosthesis |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110096
|
Zimmer |
Converge reti-lock multi-hole reinforcement cup |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110097
|
Zimmer |
Epsilon metasul 32mm acetabular inserts, standard and hooded |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110098
|
Zimmer |
Alpha metasul 28mm and 32mm acetabular inserts, standard and hooded |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110100
|
Zimmer |
Modified anatomic porous replacement apr acetabula |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110101
|
Zimmer |
Schuster acetabular cup for cement/cementless fix |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110102
|
Zimmer |
Clx acetabular cup (wagner) for cementless fixation |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110105
|
Zimmer |
Apr metasul acetabular insert |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Other |
PS110106
|
Zimmer |
Inter-op metasul acetabular system |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110107
|
Zimmer |
Inter-op metasul hooded and protrusio acetabular inserts |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Other |
PS110108
|
Zimmer |
Allofit acetabular system |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110109
|
Zimmer |
Ascendent acetabular system |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Other |
PS110110
|
Zimmer |
Durom acetabular component and metasul ldh large diameter heads |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110111
|
Zimmer |
Zimmer porolock mis stem |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110112
|
Zimmer |
Zimmer mmc cup |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110113
|
Zimmer |
Metasul taper liners, metasul femoral heads |
Orthopedic |
05/06/2011 |
Cross-sectional Plan
|
Consolidated |
Prospective Study plan
|
Terminated |
PS110114
|
Zimmer |
Zimmer threaded acetabular cup |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Terminated |
PS110115
|
Zimmer |
Zimmer m/l taper hip prosthesis with modular neck technology |
Orthopedic |
05/06/2011 |
Cross-sectional Plan
|
Consolidated |
Prospective Study Plan
|
Terminated |
PS110116
|
Zimmer |
Zimmer m/l taper hip prosthesis with kinectiv technology system, model(s) 7848 series( modular necks), 7713 series |
Orthopedic |
05/06/2011 |
Cross-sectional Plan
|
Consolidated |
Prospective Study Plan
|
Terminated |
PS110117
|
Zimmer |
Versys epoch fullcoat hip prosthesis, model 4088 series |
Orthopedic |
05/06/2011 |
Metal ion levels
|
Consolidated |
PS110118
|
Zimmer |
Zimmer m/l taper hip prosthesis with kinectiv technology system |
Orthopedic |
05/06/2011 |
Cross-sectional Plan
|
Consolidated |
Prospective Study Plan
|
Terminated |
PS090016
|
Zimmer Spine |
Zimmer® dynesys® spinal system with dto implant |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS090017
|
Zimmer Spine |
Zimmer® dynesys® top-loading spinal system |
Orthopedic |
10/05/2009 |
Fusion, AEs, Surg Procedures
|
Terminated |
PS040001
|
ZOLL Circulation, Inc. |
Alsius coolgard 3000/coolline catheter thermal regulation system |
Neurology |
03/05/2004 |
Mortality Study
|
Completed |