31 results · 22ms · Sources: EU EUDAMED, US FDA

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Bone Cement

FDA Pre-Market Approval
FDA Class 2 ·OMNIPLASTIC BONE CEMENT

Ivostar Gnathostar

FDA UDI
IVOCLAR VIVADENT AKTIENGESELLSCHAFT·DIVO5171131·Gnathostar Set of 8 UD88 6C

Leva™ Spacer System

FDA UDI
Spine Wave, Inc.·10840642100341·Fixed Implant 25mm x 10mm x 13mm

Plateau Spacer System

FDA UDI
Life Spine, Inc.·00190837047184·ALIF Controlled Deployment Device

Novaclips

FDA UDI
VITALITEC INTERNATIONAL, INC.·00852621004031·Vascular Clamp

TriVerse Meniscal Insert AS

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215101442·

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 25, 2013

2124215-2012-17113

FDA Adverse Event
Malfunction ·GUIDANT PUERTO RICO BV·Product code LWS·January 14, 2013

3005075853-2019-17113

FDA Adverse Event
Malfunction ·March 8, 2019

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 18, 2008

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2024

THINWALLED FEP RINGED GORE-TEX VASCULAR GRAFT

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES, INC.·Product code DSY·November 19, 2007

THINWALLED FEP RINGED GORE-TEX VASCULAR GRAFT

FDA Adverse Event
Injury ·W.L. GORE & ASSOCIATES, INC.·Product code DSY·November 16, 2007

ANGIO-SEAL

FDA Adverse Event
Injury ·THE KENDALL CO.·Product code MGB·April 5, 1999

THERMOPHORE

FDA Adverse Event
Malfunction ·BATTLE CREEK EQUIPMENT CO.·Product code IRT·August 28, 1997

SURESTEP

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·February 16, 2001

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·October 12, 2022

ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MZF·November 8, 2016

LTV 1200 VENTILATOR

FDA Adverse Event
Malfunction ·VYAIRE MEDICAL INC.·Product code CBK·September 19, 2022

ONE TOUCH ULTRA2 METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·July 27, 2009