10 results · 26ms · Sources: EU EUDAMED, US FDA

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BRACKET, METAL REINFORCED PLASTIC

FDA 510(k)
FDA Class 2 ·Dental

The Orthodontic Store

FDA UDI
Young Innovations, Inc.·00843471162514·Trumpeted Bondable Nonconvertible Buccal Tube, ...

P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS

FDA 510(k)
FDA Class 2 ·Dental

Additive Orthopaedics Patient Specific 3D Printed Bone Segments

FDA 510(k)
FDA Class 2 ·Orthopedic

CORAIL REVISION STEM HO 16

FDA Adverse Event
Injury ·DEPUY FRANCE SAS - 3003895575·Product code LZO·September 11, 2025

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·January 3, 2014

PROSIMA PELVIC FLOOR REPAIR KIT

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·October 10, 2012

FREESTYLE FLASH

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 12, 2007

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 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