32 results
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29ms
·
Sources: EU EUDAMED, US FDA
FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Harvard Ionoglas Fill LC A3
FDA UDI
Harvard Dental International GmbH·EHAR70521151·Resin modified glass ionomer restorative cement...
Oph.Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668115985·Tying Forcep, Straight, 4", Titanium
VISICOIL MR
FDA UDI
Izi Medical Products, LLC·EIBASNMR05001021150·0.50mm x 01.0cm VISICOIL MR Platinum loaded in ...
VISICOIL MR
FDA UDI
Izi Medical Products, LLC·B887SNMR05000521150·0.50mm x 0.5cm VISICOIL MR Platinum loaded in a...
VISICOIL MR
FDA UDI
Izi Medical Products, LLC·EIBASNMR05000521150·0.50mm x 0.5cm VISICOIL MR Platinum loaded in a...
VISICOIL MR
FDA UDI
Izi Medical Products, LLC·EIBASNMR05000521200·0.50mm x 0.5cm VISICOIL MR Platinum loaded in a...
A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
SERIM BLOOD LEAK TEST STRIP-2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SLEEPEASY
FDA Adverse Event
Injury
·RESPIRONICS INC.·Product code BZD·April 12, 2012
REMSTAR PLUS M-SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·May 6, 2010
REMSTAR M SERIES
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code BZD·November 25, 2009
M-SERIES DC POWER SUPPLY
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·May 25, 2012
CAPIOX HEMOCONCENTRATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code KDI·March 3, 2016
CELL-DYN DILUENT/SHEATH
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007
IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
FDA Enforcement
Class II
·Terminated·International Biophysics Corp.·August 26, 2015
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 11, 2013
RUSCH SAFETY CLEAR PLUS ENDOTRACHEAL TUBE
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTR·March 1, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 2, 2014
REMSTAR PLUS M-SERIES
FDA Adverse Event
Death
·RESPIRONICS, INC.·Product code BZD·March 16, 2012