22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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physIQ Heart Rhythm and Respiratory Module
FDA 510(k)
FDA Class 2
·Cardiovascular
CoRoent
FDA UDI
Nuvasive, Inc.·00887517639042·CoRoent Ant TLIF PEEK, 8x13x32mm 12°
Vanguard® SSK Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304440913·
EVERCROSS 0.035 OTW PTA DILATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
NEUROMETRIX BIOAMPLIFIER
FDA 510(k)
FDA Class 2
·Neurology
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·February 29, 2024
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·December 6, 2021
ADVIA CENTAUR XP
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·October 17, 2014
HIP 2.3 CURVED SYSTEM
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ASDD·Product code NBH·July 28, 2011
CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code HXX·June 21, 2013
Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020
VNGD SSKPSC TIB BRG S 12X63/67
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 3, 2025
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EYB·July 2, 2024
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code EZL·February 28, 2022
VANGAURD SSK INTERLOCKING FEMORAL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018
VANGUARD DISTAL FEMORAL AUGMENT 60X5 LL/RM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·August 11, 2017
BIOMET SPLINED KNEE STEM 14X80
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·August 11, 2017
VANGUARD SSKPSC TIBIAL BEARING S 12X63/67
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 21, 2017
VANGUARD DISTAL FEMORAL AUGMENT 60X5 RL/LM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·August 11, 2017
UPJ OCCLUSION BALLOON CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code EZL·July 8, 2022