14 results · 35ms · Sources: EU EUDAMED, US FDA

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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