14 results
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35ms
·
Sources: EU EUDAMED, US FDA
VARIOUS REAGENTS FOR BLOOD CELL ANALYZER
FDA 510(k)
FDA Class 1
·Hematology
Preat
FDA UDI
Preat Corporation·00842092170052·2.5mm Stainless Cap Housing (2-Pack)
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306809828·Power Adapter, 60cc Monoject
ACUMED
FDA UDI
Acumed LLC·10806378040368·1.5mm A/O Solid Hex Driver Tip
Envoy Percutaneous Implant Guide System
FDA UDI
SPINEOLOGY INC.·M7402800180·Distractor, 8mm
Monkey Rings™ External Fixation System
FDA UDI
Paragon 28, Inc.·00889795115744·Arch Ring - 180mm
ACTIS
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code MEH·April 22, 2026
MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)
FDA 510(k)
FDA Class 2
·Ophthalmic
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Death
·DATASCOPE CORP.·Product code DSP·February 23, 1998
LIMA HIP
FDA Adverse Event
Injury
·ENCORE MEDICAL, L.P.·Product code LWJ·May 8, 2014
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·October 22, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 29, 2007
Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; CD1211-36/100006983, 100012542, 100016679, 100031495, 100035634, 100035635, 100042587, 100047090; CD1211-36Q/100004079, 100004081, 100019783, 100035607, 100042591, 100047191; CD1215-36/100006990, 100010230, 100010241, 100010242, 100010244, 100012563, 100012564, 100034631, 100046574, 100046786; CD1215-36Q/100006768, 100006769, 100006770, 100023300, 100030306, 100033794, 100042402, 100046720, 100046904; CD1217-36/100011824; CD1219-36/100002160, 100002864, 100011826; CD1219-36Q/100004071, 100023301; CD2211-36/100006982, 100012536, 100016678, 100031440, 100035629, 100035636, 100042520, 100047192; CD2211-36Q/100004085, 100004087, 100019782, 100035587, 100042575, 100047193; CD2215-36/100006992, 100010224, 100010226, 100010227, 100010228, 100012515, 100012516, 100036606, 100046676, 100046792, 60019063; CD2215-36Q/100006762, 100006763, 100006764, 100023302, 100029180, 100033793, 100042404, 100046789, 100046905; CD2217-36/100011828, 100046991, 60016124-401; CD2219-36/100002139, 100002140, 100002862, 100011830; CD2219-36Q/100023303
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018