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

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METHADONE MICROPLATE EIA URINE APPLICATION

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04051526780798·LEVAMED ACTIVE ANKLE SUP SLVR R I

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040014028·Zirlux 16+ A4 98.5X20

Kwire tip protector Dia 1.2/1.6 mm sterile

FDA UDI
IN2BONES·03760225714782·Kwire tip protector Dia 1.2/1.6 mm sterile

PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB

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

3D HDRAULIC FINE MICROMANIPULATOR MO-188NE

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

CM TITAMAX IMPLANT 4.0X7

FDA Adverse Event
Injury ·NEODENT - JJGC S.A.·Product code DZE·April 13, 2018

NAIL, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code JDS·March 31, 2014

ENDOPATH ETS

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·November 7, 1997

PLATE

FDA Adverse Event
Injury ·DEPUY SYNTHES·Product code HRS·May 15, 2014

UNKNOWN CAGE/SPACER

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SàRL CH·Product code MAX·August 28, 2019

OT ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·March 8, 2011

IDENTITY DR

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2008

ENDOPATH ETS FLEX

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·February 6, 1998

SCREW

FDA Adverse Event
Injury ·DEPUY SYNTHES·Product code HWC·May 15, 2014

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·May 7, 2022

STENT - VASCULAR RECONSTRUCTION

FDA Adverse Event
Injury ·MEDOS INTERNATIONAL SARL·Product code NJE·December 9, 2021

Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

FDA Enforcement
Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.

FDA Recall
Terminated ·Product code HRY·April 22, 2011