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

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BAXANO IO-FLEX SYSTEM

FDA Adverse Event
Other ·BAXANO, INC.·Product code HAE·July 2, 2012

BAXANO IO-FLEX SYSTEM

FDA Adverse Event
Other ·BAXANO, INC.·Product code HAE·July 2, 2012

BAXANO IO-FLEX SYSTEM

FDA Adverse Event
Other ·BAXANO, INC.·Product code HAE·July 2, 2012

MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES

FDA 510(k)
FDA Class 2 ·Neurology

Endo Carry-On Procedure Kit

FDA UDI
MEDIVATORS INC.·00677964066931·Endo Carry-On Procedure Kit

BETA TITANIUM ARCHWIRE

FDA UDI
Ortho Organizers, Inc.·00190707067243·.019 X .025 Lower Pro Form™ Beta Titanium Archw...

McKesson

FDA UDI
MCKESSON MEDICAL-SURGICAL INC.·00612479241831·Therapy Putty xx-soft resistance level 4 oz

QUANTA SYSTEM S.P.A.

FDA Adverse Event
Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012

ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

FISTULOK FISTULA NEEDLE PROTECTION

FDA 510(k)
FDA Class 2 ·General Hospital

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014

TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 24, 2011

ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

FDA Adverse Event
Injury ·SYNTHES USA·Product code NKB·January 18, 2016

PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HWC·June 7, 2013

5.5MM TI CURVED ROD 45MM

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·February 6, 2020

Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage: The Navigation System II-Cart is intended to be used as a platform for computer assisted surgery as part of the Stryker Navigation System. The intended use of the complete Stryker Navigation System is defined by the Stryker application modules.

FDA Enforcement
Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 24, 2015

IVEA Product Part Number 16100 Model 500A

FDA Enforcement
Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021