10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERTIFLEX DIRECT DECOMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ArgenZ HT+ 95x10 B1
FDA UDI
ARGEN CORPORATION, THE·D818122662·Dental porcelain/ceramic restoration kit
DIATEK CANNON-CATHETER, MODEL CC5500
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROFRANCE(R) WORMALD VASCULAR CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·June 8, 2018
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 21, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·FREEDOM DESIGNS INC·Product code IOR·September 26, 2014
ARTICUL/EZE BALL 32 +1 GR
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·June 3, 2011
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·November 25, 2024
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