18 results · 30ms · Sources: EU EUDAMED, US FDA

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leva Pelvic Health System

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

LATIS SPACER

FDA 510(k)
FDA Class 2 ·Orthopedic

PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

TOTAL CARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·October 6, 2014

PFC SIGMA TIB TRAY CEM SZ3

FDA Adverse Event
Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·August 12, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 9, 2013

SURESCAN

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 13, 2016

PINNACLE MTL INS NEUT36IDX52OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 7, 2013

5.0MM DIA TPRD HD PER SCRW 35

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 23, 2013

5.0MM DIA TPRD HD PER SCRW 30

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 23, 2013

PINN CAN BONE SCREW 6.5MMX40MM

FDA Adverse Event
Injury ·DEPUY-RAYNHAM, A DIV. OF DEPUY - REG. # 1219655·Product code NDJ·May 23, 2013

PINN CAN BONE SCREW 6.5MMX20MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 23, 2013

PINN CAN BONE SCREW 6.5MMX25MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 23, 2013

PINNACLE SECTOR II CUP 52MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 23, 2013

PINN CAN BONE SCREW 6.5MMX20MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code NDJ·May 23, 2013

ARTICULEZE M HEAD 36MM +1.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 7, 2013

ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

FDA Enforcement
Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019