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U.S. Department of Health and Human Services

Medical Device Recalls
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Impella RP with SmartAssist. Product Code: 0046-0035. 1 02/27/2026 FEI # 1220648
Abiomed, Inc.
Impella RP. Product Code: 0046-0011. 1 02/27/2026 FEI # 1220648
Abiomed, Inc.
Impella RP Flex with SmartAssist. Product Code: 1000323. 1 02/27/2026 FEI # 1220648
Abiomed, Inc.
Impella 5.5 with SmartAssist® S2, Impella 5.5 with SmartAssist S2 Set, AU. 2 01/08/2026 FEI # 1220648
Abiomed, Inc.
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM ... 2 10/01/2025 FEI # 3004201263
S.I.N. Implant System Ltda
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N 2 01/15/2025 FEI # 3004201263
SIN SISTEMA DE IMPLANTE NACIONAL S.A
Impella RP with SmartAssist; Product Number: 0046-0035; 1 01/15/2025 FEI # 1220648
Abiomed, Inc.
Impella RP Flex with SmartAssist; Product Number: 1000323; 1 01/15/2025 FEI # 1220648
Abiomed, Inc.
Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella CP Smart Assist Set; Product Code: 1000402; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella 5.5 Set AU; Product Code: 1000361; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella CP Smart Assist Set, EU; Product Code: 0048-0014; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella CP Pump Set, Japan; Product Code: 0048-0034-JP; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella CP Smart Assist Set, Canada; Product Code: 0048-0044; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella CP Smart Assist Set APAC; Product Code: 0048-0047; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella 5.5 SmartAssist Set, JP; Product Code: 1000211; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
ImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302; 2 09/04/2024 FEI # 1220648
Abiomed, Inc.
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump 1 07/17/2024 FEI # 1220648
Abiomed, Inc.
impression coping, repositionable, short, screw-retained, PF 4.0 2 03/20/2024 FEI # 3003184527
Thommen Medical AG
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory syste... 2 02/12/2024 FEI # 1220648
Abiomed, Inc.
Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory syste... 1 02/09/2024 FEI # 1220648
Abiomed, Inc.
Impella Connect, software portal for online device management that allows clinicians and Impella sup... 2 01/04/2024 FEI # 1220648
Abiomed, Inc.
IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062... 2 08/24/2023 FEI # 1000432246
Medicrea International
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B153... 2 08/24/2023 FEI # 1000432246
Medicrea International
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B2024... 2 08/24/2023 FEI # 1000432246
Medicrea International
IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B... 2 08/24/2023 FEI # 1000432246
Medicrea International
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B201... 2 08/24/2023 FEI # 1000432246
Medicrea International
IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B161... 2 08/24/2023 FEI # 1000432246
Medicrea International
IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar 2 08/24/2023 FEI # 1000432246
Medicrea International
IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; interve... 2 08/24/2023 FEI # 1000432246
Medicrea International
IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20... 2 08/24/2023 FEI # 1000432246
Medicrea International
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323 1 08/03/2023 FEI # 1220648
Abiomed, Inc.
Impella CP with SmartAssist intravascular micro axial blood pump, Product Numbers 0048-0024, 0048-00... 1 07/14/2023 FEI # 1220648
Abiomed, Inc.
Impella CP intravascular micro axial blood pump, Product Number 0048-0032 1 07/14/2023 FEI # 1220648
Abiomed, Inc.
Impella 5.5 with SmartAssist intravascular micro axial blood pump, Product Numbers 0550-0008 and 100... 1 07/14/2023 FEI # 1220648
Abiomed, Inc.
Impella LD intravascular micro axial blood pump, Product Number 005082 1 07/14/2023 FEI # 1220648
Abiomed, Inc.
Impella 5.0 intravascular micro axial blood pump, Product Number 005062 1 07/14/2023 FEI # 1220648
Abiomed, Inc.
Impella 2.5 intravascular micro axial blood pump, Product Number 005042 1 07/14/2023 FEI # 1220648
Abiomed, Inc.
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a pat... 1 05/18/2023 FEI # 1220648
Abiomed, Inc.
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, 2 11/03/2021 FEI # 3001617766
Implant Direct Sybron Manufacturing LLC
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, 2 11/03/2021 FEI # 3001617766
Implant Direct Sybron Manufacturing LLC
Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 m... 1 09/29/2021 FEI # 3014590708
IMPERATIVE CARE INC
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Addi... 2 05/04/2021 FEI # 2182208
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrh... 2 05/04/2021 FEI # 2182208
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viv... 1 03/27/2021 FEI # 2182208
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI ... 1 03/27/2021 FEI # 2182208
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100 2 03/16/2021 FEI # 3015060224
Imactis
Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove imp... 2 02/19/2020 FEI # 1000125598
Nobel Biocare Usa Llc
Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - Product Usage: They can be used to remove im... 2 02/19/2020 FEI # 1000125598
Nobel Biocare Usa Llc
Implant Retrieval Instrument CC 3.0 31 mm- Product Usage: They can be used to remove implants, if th... 2 02/19/2020 FEI # 1000125598
Nobel Biocare Usa Llc
Implant Retrieval Instrument CC NP & Ext Hex WP 22 mm - Product Usage: They can be used to remove im... 2 02/19/2020 FEI # 1000125598
Nobel Biocare Usa Llc
Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm - Product Usage: They can be used to remov... 2 02/19/2020 FEI # 1000125598
Nobel Biocare Usa Llc
Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but inc... 2 02/19/2020 FEI # 1000125598
Nobel Biocare Usa Llc
Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove impla... 2 02/19/2020 FEI # 1000125598
Nobel Biocare Usa Llc
Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7... 2 02/05/2020 FEI # 3001617766
Implant Direct Sybron Manufacturing LLC
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, ... 2 01/08/2020 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, ... 2 01/08/2020 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mm... 2 11/12/2019 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, ... 2 11/12/2019 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3... 2 10/31/2019 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile... 2 10/01/2019 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx,... 2 10/01/2019 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product U... 2 10/30/2018 FEI # 1315551
CMP Industries, Llc
Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental impla... 2 10/09/2018 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The... 2 08/12/2018 FEI # 3008449424
Guangzhou Improve Medical Instruments Co., Ltd.
ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower ja... 2 07/26/2018 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect c... 2 05/23/2018 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, S... 2 05/23/2018 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform 2 02/06/2018 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
Implantable Cardioverter Defibrillators (ICDs), Visia AF MRI. Labeled as the following: a. Visia A... 1 02/01/2018 FEI # 2182208
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD... 1 02/01/2018 FEI # 2182208
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MR... 1 02/01/2018 FEI # 2182208
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Implantable Cardioverter Defibrillators (ICDs), Visia AF. Labeled as: a. Visia AF VR ICD DF1 (Pro... 1 02/01/2018 FEI # 2182208
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implan... 2 11/29/2017 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Denta... 2 10/03/2017 FEI # 3001617766
Implant Direct Sybron Manufacturing, LLC
IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CA... 2 09/22/2017 FEI # 1038806
Zimmer Dental Inc
IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT... 2 09/22/2017 FEI # 1038806
Zimmer Dental Inc
IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interf... 2 06/29/2017 FEI # 3001236302
AGFA Healthcare Corp.
Implant Twist Lock TM Coping Dental implants 2 08/12/2016 FEI # 1038806
Biomet 3i, LLC
Implant EP Twist Lock TM Coping Dental implants 2 08/12/2016 FEI # 1038806
Biomet 3i, LLC
Implant EP Pick-Up Coping Dental implants 2 08/12/2016 FEI # 1038806
Biomet 3i, LLC
Implant Cover Screw Dental implants 2 08/12/2016 FEI # 1038806
Biomet 3i, LLC
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FO... 2 06/29/2016 FEI # 1315551
CMP Industries, Llc
IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liqu... 2 06/29/2016 FEI # 1315551
CMP Industries, Llc
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLI... 2 06/29/2016 FEI # 1315551
CMP Industries, Llc
IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, ... 2 03/09/2016 FEI # 1315551
CMP Industries, Llc
IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 Product Usage: Zimmer Den... 2 02/09/2016 FEI # 1038806
Zimmer Dental Inc
IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product Usage: Zimmer D... 2 02/09/2016 FEI # 1038806
Zimmer Dental Inc
IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Product Usage: Zimmer Den... 2 02/09/2016 FEI # 1038806
Zimmer Dental Inc
IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product Usage: Zimmer Den... 2 02/09/2016 FEI # 1038806
Zimmer Dental Inc
IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMT4B13 Product Usage: Zimmer De... 2 02/09/2016 FEI # 1038806
Zimmer Dental Inc
IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product Usage: Zimmer ... 2 02/09/2016 FEI # 1038806
Zimmer Dental Inc
IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Product Usage: Zimmer De... 2 02/09/2016 FEI # 1038806
Zimmer Dental Inc
IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product Usage: Zimmer Dental i... 2 02/09/2016 FEI # 1038806
Zimmer Dental Inc
IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Product Usage: Zimmer Dental... 2 02/09/2016 FEI # 1038806
Zimmer Dental Inc
IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant s... 2 02/09/2016 FEI # 1038806
Zimmer Dental Inc
IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product Usage: Zimmer Dental ... 2 02/09/2016 FEI # 1038806
Zimmer Dental Inc
IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product Usage: Zimmer Dental ... 2 02/09/2016 FEI # 1038806
Zimmer Dental Inc
IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Product Usage: Zimmer Denta... 2 02/09/2016 FEI # 1038806
Zimmer Dental Inc
IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects... 2 11/17/2015 FEI # 3001236302
AGFA Healthcare Corp.
IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications... 2 07/13/2015 FEI # 3001236302
AGFA Healthcare Corp.
IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISH... 1 08/29/2014 FEI # 2648727
Customed, Inc
IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF ( I) TUBE S... 1 08/29/2014 FEI # 2648727
Customed, Inc
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognitio... 2 05/27/2014 FEI # 3001236302
AGFA Corp.
IMPAX RIS QDOC 5.8 2 02/03/2014 FEI # 3001236302
AGFA Corp.
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication... 2 10/21/2013 FEI # 3001236302
AGFA Corp.
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effectiv... 2 04/08/2013 FEI # 3001236302
AGFA Corp.
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates di... 2 04/08/2013 FEI # 3001236302
AGFA Corp.
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured r... 2 08/10/2012 FEI # 3001236302
AGFA Corp.
IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick... 2 07/24/2012 FEI # 3001236302
AGFA Corp.
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is la... 2 06/20/2012 FEI # 1038806
Biomet 3i, LLC
Implantable Pacemaker Accent DR models PM2110 and PM2210 St. Jude Medical pacemakers monitor and ... 2 01/11/2012 FEI # 2017865
St Jude Medical CRMD
IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular informati... 2 11/23/2011 FEI # 3001236302
AGFA Corp.
IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2 The IM... 2 11/18/2011 FEI # 3001236302
AGFA Corp.
IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascula... 2 11/18/2011 FEI # 3001236302
AGFA Corp.
Impac Medical Systems Sequencer Product Usage: The intended us of Sequencer is to assists in the... 2 10/17/2011 FEI # 1000123805
Impac Medical Systems Inc
IMPAX CV (Cardio Vascular) The IMPAX Cardiovascular suite is a cardiovascular information system,... 2 06/10/2011 FEI # 3001236302
AGFA Corp.
IMPAX 6.5 Client Software. IMPAX 6.5 combines the traditional activities of RIS informatics manag... 2 05/24/2011 FEI # 3001236302
AGFA Corp.
IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8 2 03/16/2011 FEI # 3001236302
AGFA Corp.
IMPAX CV Results Manager/Results Manager Administration Tool The IMPAX Cardiovascular suite is a ... 2 02/25/2011 FEI # 3001236302
AGFA Corp.
Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is intended f... 2 09/07/2010 FEI # 1220648
Abiomed, Inc.
IMPAX CV Results Manager/Results Manager Administration Tool 2 07/29/2010 FEI # 3001236302
AGFA Corp.
IMPACT Catheters, Balloon Dilatation and Esophageal Dilatation Catheter, Model Number 307, STERILE, ... 2 12/15/2009 FEI # 1318694
Numed Inc
IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numb... 2 02/03/2009 FEI # 3001236302
AGFA Corp.
Impression Therapist 3rd party V&R equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3... 2 10/16/2008 FEI # 2937457
Siemens Medical Solutions USA, Inc
IMPAX® 4.1, IMPAX ® 4.5, IMPAX ® 5.0, IMPAX ® 5.1 IMPAX ® 5.2, IMPAX ® 6.0, IMPAX ® 6.2; Picture Arc... 2 09/11/2008 FEI # 3001236302
AGFA Corp.
IMPAX® 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, tran... 2 09/11/2008 FEI # 3001236302
AGFA Corp.
Impax® 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 an... 3 09/04/2008 FEI # 3001236302
AGFA Corp.
Implantable Cardioverter Defibrillator EPIC + VR Tiered-therapy cardioverter/defibrillator, Model V... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC DR Tiered-therapy cardioverter/defibrillator, Model V-2... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy cardioverter/defibrillator, Model V... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC + DR Tiered-therapy cardioverter/defibrillator, Model V... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC + HF Tiered-therapy cardioverter/defibrillator with biv... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC II VR Tiered-therapy cardioverter/defibrillator, Model... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC II DR Tiered-therapy cardioverter/defibrillator, Model... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC II+ DR Tiered-therapy cardioverter/defibrillator, Mode... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC II HF Tiered-therapy cardioverter/defibrillator with B... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC II+ HF Tiered-therapy cardioverter/defibrillator with ... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC II+ HF Tiered-therapy cardioverter/defibrillator with ... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS + VR Tiered-therapy cardioverter/defibrillator, Model ... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS DR Tiered-therapy cardioverter/defibrillator, Model V-... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS + DR Tiered-therapy cardioverter/defibrillator, Model ... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy cardioverter/defibrillator with bi... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy cardioverter/defibrillator with bi... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS + HF Tiered-therapy cardioverter/defibrillator with bi... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS II VR Tiered-therapy cardioverter/defibrillator, Model... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS II DR Tiered-therapy cardioverter/defibrillator, Model... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS II+ DR Tiered-therapy cardioverter/defibrillator, Mod... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS II HF Tiered-therapy cardioverter/defibrillator with b... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy cardioverter/defibrillator with ... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator ATLAS II+ HF Tiered-therapy cardioverter/defibrillator with ... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy Cardioverter/defibrillator with biven... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC HF Tiered-Therapy Cardioverter/Defibrillator with Biven... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC HF Tiered-therapy cardioverter/defibrillator with biven... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC VR Tiered-therapy Cardioverter/Defibrillator, Model V-... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Implantable Cardioverter Defibrillator EPIC DR Tiered-Therapy Cardioverter/Defibrillator, Model V-... 2 08/19/2008 FEI # 2017865
St Jude Medical CRMD
Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Vox... 2 07/02/2008 FEI # 3001236302
AGFA Corp.
IMPAX® 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is us... 2 07/01/2008 FEI # 3001236302
AGFA Corp.
Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Lo... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A ... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A ... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-free A ... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Lo... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber catheter. Latex Free ... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Ref Product N... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A ... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A ... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Lo... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Lo... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Lo... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Lo... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Lo... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implantable Vascular Access system --Infusion Ports with Silicone Rubber Catheter. Latex-free A P... 2 12/19/2006 FEI # 3015859709
Arrow International Inc
Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tenne... 2 10/19/2006 FEI # 3004564008
Medtronic Sofamor Danek Instrument Manufacturing
IMPAX® 5.2 Systems with CAD Capability (Computer Assisted Diagnosis) 2 10/12/2006 FEI # 3001236302
AGFA Corp.
IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medi... 3 07/27/2006 FEI # 3001236302
AGFA Corp.
Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV Valve and 6.6F Silicone Cathe... 2 01/06/2006 FEI # 3001451463
Boston Scientific Corporation
Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F Silicone Cathet... 2 01/06/2006 FEI # 3001451463
Boston Scientific Corporation
Implantable Chest Ports With PASV Valve Technology -Single Lumen - PASV Port/6.6/SL/T/PA Catalog Nu... 2 09/02/2005 FEI # 3001451463
Boston Scientific Corporation
Implantable Chest Ports With PASV Valve Technology - Dual Lumen - PASV Port/10/DL/T/A Catalog Numbe... 2 09/02/2005 FEI # 3001451463
Boston Scientific Corporation
Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/6.6/SL/T/A Catalog Nu... 2 09/02/2005 FEI # 3001451463
Boston Scientific Corporation
Implantable Chest Ports With PASV Valve Technology - Dual Lumen - PASV Port/10/DL/T/PA Catalog Numb... 2 09/02/2005 FEI # 3001451463
Boston Scientific Corporation
Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/9.6/SL/T/A Catalog Nu... 2 09/02/2005 FEI # 3001451463
Boston Scientific Corporation
Implantable Chest Ports With PASV Valve Technology - Single Lumen - PASV Port/9.6/SL/T/PA Catalog N... 2 09/02/2005 FEI # 3001451463
Boston Scientific Corporation
Implantable Cardioverter Defibrilators Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/... 2 07/19/2005 FEI # 2017865
St Jude Medical
Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-... 2 04/13/2005 FEI # 2017865
St Jude Medical
Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-... 2 09/29/2004 FEI # 1046367
Deroyal Surgical -Rose Hill
Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011 2 07/20/2004 FEI # 3002095335
Boston Scientific Scimed
 
 
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