9 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.

TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET

FDA 510(k)
FDA Class 2 ·Cardiovascular

LEVEL ONE CMF

FDA UDI
KLS-Martin L.P.·00888118094032·MESH, STANDARD, CONTOURED, 1.5 MM SCREW, CP TIT...

CD 3700 SL

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 23, 2007

STC DIAGNOSTICS BENZOYLECGONINE EIA

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

ARTHRO-FMS-3/IRRIGATION SETS (VARIOUS)

FDA 510(k)
FDA Class 2 ·Orthopedic

MAQUET HCU40 DEVICE

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DWC·April 3, 2014

ADVANTAGE SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 11, 2013

TENDRIL SDX

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

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