12 results
·
25ms
·
Sources: EU EUDAMED, US FDA
OBA(TM) READER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Edge™ Diamond ND010-10C Needle
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172016803·Diamond dental bur, reusable
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909110452·REVELATION DIAMOND 885-010C - 5 PACK
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756393201·NEURO ANGIO PACK
TAPAS® Catheter
FDA UDI
Thermopeutix, Inc.·M7819110451·The TAPAS® Catheter consists of a two concentri...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111061738·5000 BIOP PNCH W/TTH 45CM 5MM
CENTRO FAMILY OF MANUAL WHEELCHAIRS
FDA 510(k)
FDA Class 1
·Physical Medicine
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
FDA 510(k)
FDA Class 1
·General Hospital
CVC SET: 14 GA X 20 CM
FDA Adverse Event
Injury
·ARROW INTERNATIONAL, INC.·Product code DQY·November 24, 2010
UNKNOWN REJUVENATE NECK
FDA Adverse Event
Injury
·STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI·Product code JDI·January 4, 2013
UNIFY CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·July 2, 2014
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024