14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GRIDLOCK PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1284520·Tube, Guidewire, 520MM
MaxFuse VBR, 10 (D) x 12 (W) x 59 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055721·10 (D) x 12 (W) x 59 (H)
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973837·
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW
FDA 510(k)
FDA Class 2
·Radiology
STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929064863·Corpectomy, 12Dx14Wx52H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929040737·Corpectomy, 12Dx14Wx52H 6°
LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 11, 2022
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
CHROMOPHARE
FDA Adverse Event
Malfunction
·BERCHTOLD CORP.·Product code FQP·May 6, 2011
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
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026