14 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SPLIT CATH III
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
BD CONNECTA¿ STOPCOCK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·February 14, 2019
BD SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 19, 2019
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 3, 2019
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 4, 2019
QUARTET
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·January 13, 2014
8MM TI CANNULATED TIBIAL NAIL EX/330MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code JDS·May 3, 2013
UNKNOWN DEPUY 35MM OVAL DOME PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·June 2, 2011
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 24, 2019
SYR 10ML SURESCRUB POSIFLUSH SALINE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 14, 2020
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 12, 2016
BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.
FDA Enforcement
Class II
·Terminated·OPTI Medical Systems, Inc·October 3, 2012