15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AQUARIUS EXTENSION FEEDING SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Oticon
FDA UDI
Oticon A/S·05707131271570·RIA PRO, KIT 10 WL OMNI 85 PB BE
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWQ·October 23, 2019
ZEVO ANTERIOR CERVICAL PLATE SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWQ·December 19, 2018
REMINGTON I-LIGHT HAIR REMOVAL SYSTEM
FDA Adverse Event
Injury
·SHASER INC·Product code ONF·May 21, 2021
FORA GD20 BLOOD GLUCOSE MONITORING SYSTEM, U-RUGHT TD-4252D BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN..
FDA 510(k)
FDA Class 2
·Orthopedic
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065525·Corpectomy, 14Dx16Wx31H 6°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929065167·Corpectomy, 14Dx16Wx31H 0°
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·December 11, 2019
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·December 3, 2019
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2011
MEDTRONIC SYNCROMED II IMPLANTABLE INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION PATIENT SERVICES·Product code MEB·August 28, 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