13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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A-GRIX TE RESORABLE BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
MaxFuse VBR, 10 (D) x 12 (W) x 59 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055738·10 (D) x 12 (W) x 59 (H)
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973837·
VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
FDA 510(k)
FDA Class 2
·Dental
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
FDA 510(k)
FDA Class 3
·Cardiovascular
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929045138·Corpectomy, 12Dx14Wx53H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929064870·Corpectomy, 12Dx14Wx53H 0°
IDENTITY DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 2, 2015
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 14, 2025
MONOSYN VIOLET 4/0(1,5)70CM DS19 (M) RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·April 7, 2022
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