25 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

3MP COLOR LCD MONITOR, RADIFORCE RX340

FDA 510(k)
FDA Class 2 ·Radiology

N/A

FDA UDI
HANS RUDOLPH, INC.·00874750001484·66 V2 ASSY SMALL 22ID W/HG

COMPREHENSIVE SHOULDER SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304430808·

Comprehensive® Shoulder System

FDA UDI
Biomet Orthopedics, LLC·00880304591561·

Comprehensive® Shoulder System

FDA UDI
Biomet Orthopedics, LLC·00887868343841·

BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·July 27, 2021

AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

CENTURION PRESSURE INJECTABLE EXTENSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

BD BBL¿ TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·July 27, 2021

TELAMON FUSION DEVICE

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code MAX·August 5, 2016

TELAMON® FUSION DEVICE

FDA Adverse Event
Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·August 3, 2012

TELAMON® FUSION DEVICE

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code MAX·August 3, 2012

TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code JEY·May 31, 2019

IMPAX CV OUTBOUND (RESULTS MGMT 2.08)

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

ASR ACETABULAR CUPS 48

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·May 15, 2013

IMPLANTED POWERPICC

FDA Adverse Event
Injury ·C. R. BARD, INC. (BASD)·Product code LJS·June 1, 2011

COMP 12MM HUM FRAC STEM MACRO, model # 11-113562

FDA Recall
Terminated ·Zimmer Biomet, Inc.·Product code KWT·June 5, 2017

WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code LZD·August 29, 2017

COMP 12MM HUM FRAC STEM MACRO, model # 11-113562

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·January 10, 2018

BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES

FDA Adverse Event
Injury ·BIOMET MICROFIXATION·Product code HWC·June 3, 2016