27 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZENEX Implant System_Narrow
FDA 510(k)
FDA Class 2
·Dental
32MM M2A MOD HEAD STD NK
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDL·September 26, 2017
M2A-TAPER LINER SZ 41/32
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDL·September 26, 2017
PLATEAU SPACER SYSTEM TITANIUM
FDA 510(k)
FDA Class 2
·Orthopedic
EDWARDS DIRECTIONAL CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NSK
FDA Adverse Event
Malfunction
·NAKANISHI INC.·Product code EGS·July 20, 2023
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 10, 2024
PINNACLE 300 ACET CUP 54MM
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·September 20, 2012
ALTRX +4 10D 36IDX54OD
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·September 20, 2012
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code JDI·September 20, 2012
LIBERTY CYCLER
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·October 27, 2014
UV-FLASH SOLUTION TRANSFER SET(SHORT)-JAPAN
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 17, 2008
DEPUY ASR XL FEM IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KXA·July 16, 2013
Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·July 5, 2023
Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601700 9F Hickman CV Catheter Repair Kit 0601710 12F Hickman CV Catheter Repair Kit 0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601740 12.5F Hickman CV Catheter Repair Kit 0601750 10F Leonard CV Catheter Repair Kit 0601760 7F Hickman CV Catheter Repair Kit 0601790 10F Hickman CV Catheter Repair Kit
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·February 8, 2023
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 23, 2022
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·April 26, 2023
CODMAN Disposable Perforator 11mm. Cranial Perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·November 12, 2025
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 23, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Enforcement
Class I
·Terminated·TELEFLEX MEDICAL INC·February 23, 2022