16 results · 20ms · 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.

AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)

FDA 510(k)
FDA Class 2 ·Anesthesiology

Arzzt Distal Radius and Ulna System

FDA 510(k)
FDA Class 2 ·Orthopedic

SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL

FDA 510(k)
FDA Class 2 ·Orthopedic

GLOBAL UNITE STD STEM SZ 6

FDA Adverse Event
Injury ·DEPUY IRELAND 9616671·Product code MBF·May 5, 2016

MENTOR MEMORYGEL BREAST IMPLANT

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FTR·March 1, 2024

DXTEND STAND PE CUP D38 +3MM

FDA Adverse Event
Injury ·DEPUY FRANCE SAS 3003895575·Product code KWS·May 18, 2016

ECHOTIP PROCORE HD ULTRASOUND BIOPSY NEEDLE

FDA Adverse Event
COOK IRELAND LTD·Product code FCG·February 21, 2013

SYBRONPRO TL

FDA Adverse Event
Injury ·EBI INC.·Product code DZE·February 9, 2011

STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP

FDA Adverse Event
Other ·SORIN GROUP DEUTSCHLAND·Product code DWA·July 25, 2014

MENTOR MEMORYGEL BREAST IMPLANT

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code FTR·March 1, 2024

LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

SELDRILL-SCHANZSCR Ø5 L200/80 SST

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

LARGE EX-FIX 11MM CRBN FBR ROD 250MM / MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

SELDRILL-SCHANZSCR Ø5 L200/80 SST

FDA Adverse Event
Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024