15 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ANNEXTM ADJACENT LEVEL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HHM
FDA UDI
Oticon A/S·05707131257048·H160, BTE 13 WL 85 SIL HHM
K2M General Instruments
FDA UDI
VB Spine LLC·10888857562103·Dilator Size Dia. 22.5 mm
SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
FDA 510(k)
FDA Class 2
·Anesthesiology
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS -CHMV·Product code NPF·August 26, 2014
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·January 6, 2020
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·May 29, 2013
PROPEX
FDA Adverse Event
Malfunction
·DENTSPLY MAILLEFER·Product code LQY·June 13, 2011
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, PUERTO RICO, B.V.·Product code MGB·August 14, 2008
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·September 2, 2020
SMART MONITOR 2 PS
FDA Adverse Event
Malfunction
·PHILIPS RESPIRONICS - CHMV·Product code NPF·May 30, 2013
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·May 8, 2020
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·May 8, 2020
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