9 results · 24ms · Sources: EU EUDAMED, US FDA

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RUWA MATRIX STRIPS

FDA 510(k)
FDA Class 1 ·Dental

MD300K1 PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Aptis Medical Distal Radio Ulnar Joint Implant

FDA 510(k)
FDA Class 2 ·Orthopedic

LONG NAIL KIT R1.5, TI, LEFT GAMMA3 10X300MM X 12

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 7, 2012

LIGAMAX CLIP APPLIER

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 5, 2014

REVEAL DX

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL, INC.·Product code DSI·October 15, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 23, 2007

PROPONENT DR SL (Model L201)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

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