24 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.

DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005

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

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·10304040054922·Strip Crown Forms

3D

FDA UDI
Rmo, Inc.·00885797100184·3D PALATAL APPLIANCE ASST OF 6

ADD-ON CONDYLE

FDA 510(k)
FDA Class 2 ·Dental

MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM

FDA 510(k)
FDA Class 1 ·Dental

BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·October 4, 2019

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·January 26, 2012

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·January 26, 2012

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·October 15, 2009

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·December 31, 2009

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·October 29, 2009

ASR ACETABULAR CUPS 54

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·March 14, 2013

UNKNOWN ZIMMER CR FLEX FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·February 24, 2011

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·August 12, 2014

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 21, 2010

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 21, 2010

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·August 13, 2010

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code NIQ·November 27, 2006

BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013