9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ArgenZ HT+ 95x20 A1
FDA UDI
ARGEN CORPORATION, THE·D818122752·Dental porcelain/ceramic restoration kit
HEX-FIX
FDA UDI
Smith & Nephew, Inc.·03596010512819·STAINLESS STEEL HALF PIN 5MM X 45MM
PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
FDA 510(k)
FDA Class 2
·Anesthesiology
STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EXPRESS® LD ILIAC / BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIO·May 21, 2013
ASR UNI FEMORAL IMPL SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 3, 2011
THREADED GUIDEWIRE 1.6MM X 500MM
FDA Adverse Event
Injury
·SPINEFRONTIER, INC.·Product code HXI·August 18, 2008
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015