17 results · 21ms · Sources: EU EUDAMED, US FDA

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QBit Series Diagnostic Ultrasound System

FDA 510(k)
FDA Class 2 ·Radiology

HHM

FDA UDI
Oticon A/S·05707131282255·H160V2 TI, BTE 13 WL 85 TC HHM

Biomet® Patellar System

FDA UDI
Biomet Orthopedics, LLC·00887868344404·

BIOMET PATELLAR SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304207974·

PEEK CAS

FDA 510(k)
FDA Class 2 ·Orthopedic

R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100

FDA 510(k)
FDA Class 2 ·Ophthalmic

GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

GUIDE WIRE, BALL-TIPPED, STERILE T2 HUMERUS Ø2.5X800 MM

FDA Adverse Event
Malfunction ·STRYKER TRAUMA KIEL·Product code LXH·December 2, 2015

INSIGNIA

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 8, 2014

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·UNKNOWN·Product code ITI·June 6, 2013

HIP HEAD,10/12 TAPER,28MM,+0MM

FDA Adverse Event
Injury ·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code KWY·June 29, 2011

DIVA

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

DIVA

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·July 7, 2020

SENRI

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code DQY·December 25, 2016

METACROSS RX PTA BALLOON DILATATION CATHETER

FDA Adverse Event
Injury ·KANEKA CORPORATION·Product code LIT·October 15, 2019

AMISTEM H, HA COATED STEM SIZE 6 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 4, 2016

Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

FDA Enforcement
Class II ·Terminated·Ecolab Inc·September 30, 2015