27 results · 18ms · Sources: EU EUDAMED, US FDA

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WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET

FDA 510(k)
FDA Class 2 ·Immunology

Custom Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964016378·Endo Carry-On Procedure Kit

N/A

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169328679·TEMPLATE 3001931 ZEVO 31MM 1 LVL

SCANLAN® Easy-Tag™ Tracking System

FDA UDI
SCANLAN INTERNATIONAL INC·00846159033038·Easy-Tag Pre-Printed, Endo - HLD, Green 250/Spl

LIFEPAK® 15 monitor/defibrillator

FDA UDI
PHYSIO-CONTROL, INC.·00883873872086·15AACAABAABBAAAAAAAAAAAFLP15 MONITOR/DEFIB

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 30, 2026

INSET

FDA Adverse Event
Malfunction ·UNOMEDICAL UM-D·Product code FPA·March 30, 2026

URANUS, COMFORTOUCH LASER SYSTEM

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

AU5 ULTRASOUND IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

SUMMIT POR TAPER SZ6 STD OFF

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 21, 2018

ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.

FDA Recall
Terminated ·Diasorin Inc.·Product code LOM·August 19, 2010

KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER

FDA Adverse Event
Malfunction ·GMS - GESELLSCHAFT FUR MEDIZINISCHE SONDENTECHNIK - N·Product code GWM·March 11, 2013

EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NTE·February 27, 2011

DEXTRUS 4136

FDA Adverse Event
Injury ·BIOTRONIK GMBH AND CO·Product code DTB·February 15, 2008

SUMMIT POR TAPER SZ4 HI OFF

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 20, 2018

SUMMIT POR TAPER SZ6 HI OFF

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 1, 2018

METRX SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024

SUMMIT POR TAPER SZ4 HI OFF

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·September 28, 2018

SUMMIT POR TAPER SZ7 HI OFF

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·October 18, 2019

SUMMIT POR TAPER SZ4 HI OFF

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. - 8010379·Product code LPH·July 1, 2015