15 results · 33ms · Sources: EU EUDAMED, US FDA

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eUnity

FDA 510(k)
FDA Class 2 ·Radiology

Sklar®

FDA UDI
SKLAR CORPORATION·10649111322297·PEAN-NIPPON FCP STR 6 1/4"

QUIDEL MOLECULAR HMPV ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

IGX PLEX CELIAC QUALITATIVE ASSAY

FDA 510(k)
FDA Class 2 ·Immunology

UNKNOWN TRIAL POST

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·February 21, 2022

VNGD PS+ TIB BRG 12X71/75MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 27, 2021

BIOMET TIBIAL LOCKING BAR

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 27, 2021

ADVANTAGE SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013

UROMAX ULTRA BALLOON DILATION CATHETER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code EZN·September 19, 2008

TERUMO ADVANCED PERFUSION SYSTEM 1

FDA Adverse Event
Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·June 24, 2011

VAN PS OPEN INTL FEM-RT 67.5

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 12, 2023

BIOMET TIBIAL LOCKING BAR

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 12, 2023

VNGD PS+ TIB BRG

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 12, 2023

BIOMET CC CRUCIATE TRAY

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·September 12, 2023

CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

FDA Enforcement
Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017