15 results · 20ms · Sources: EU EUDAMED, US FDA

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PHILIPS THORAVISION

FDA 510(k)
FDA Class 2 ·Radiology

Polystar Selection EDITION

FDA UDI
Merz Dental GmbH·D7091981657·anteriors; shade D3 light; mould BS2

POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW)

FDA 510(k)
FDA Class 1 ·General Hospital

easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AIRVANCE BONE SCREW (REPOSE) SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code LRK·March 3, 2014

AIRVANCE BONE SCREW (REPOSE) SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC·Product code LRK·March 29, 2013

OT ULTRA TEST STRIPS

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 27, 2013

OMNIFIT AXIAL REAMER

FDA Adverse Event
Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·January 12, 2011

COMP PRIMARY STEM 7MM MINI

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code MBF·August 5, 2014

AIRVANCE¿ THS SYSTEM - BONE SCREW WITH SUTURE

FDA Adverse Event
Injury ·MEDTRONIC XOMED INC.·Product code LRK·November 30, 2015

AIRVANCE¿ THS SYSTEM - TOUNGE SUSPENSION KIT

FDA Adverse Event
Malfunction ·MEDTRONIC XOMED INC.·Product code LRK·October 2, 2015

BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 10, 2019

BD SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·July 10, 2019

BD PRECISIONGLIDE SYRINGE ALLERGY 1ML W/ NEEDLE 28X1/2 RB

FDA Adverse Event
Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 31, 2019

OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·October 13, 2021