43 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
FDA 510(k)
FDA Class 2
·Orthopedic
Spacelabs Healthcare
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522102325·SENSOR,SPO2,Y MULTI-SITE,UNIVERSAL,REUSABLE,ROHS
TruLink
FDA UDI
OSI OPTOELECTRONICS, INC.·00859998006446·SpO2 Y Multi-Site Sensor Reusable -Universal
HNM Women Care
FDA UDI
HNM STAINLESS, LLC.·00812171028284·PESSARY, GEHRUNG #0, 50mm
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295503361·Attune Knee System Revision Thick Tibial Base R...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295503354·Attune Knee System Revision Thick Tibial Base R...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295503347·Attune Knee System Revision Thick Tibial Base R...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295503378·Attune Knee System Revision Thick Tibial Base R...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295503330·Attune Knee System Revision Thick Tibial Base R...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295503316·Attune Knee System Revision Thick Tibial Base R...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295503309·Attune Knee System Revision Thick Tibial Base R...
ATTUNE
FDA UDI
DEPUY (IRELAND)·10603295503323·Attune Knee System Revision Thick Tibial Base R...
HEMOSIL FACTOR II DEFICIENT PLASMA
FDA 510(k)
FDA Class 2
·Hematology
EARPROBE
FDA 510(k)
FDA Class 2
·Neurology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014
ANEURX
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·June 6, 2013
COLLEAGUE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015
NOVOSYN QUICK UNDY 2/0(3)70CM DSMP24MDDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·April 23, 2021
NOVOSYN QUI UNDY 2/0(3)90CM HRC37S(M)DDP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·May 5, 2021