16 results · 22ms · Sources: EU EUDAMED, US FDA

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RIA PHASE TBG

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·00636257003206·M2 OA LITE BRACE, RT VAR, LT VAL, LG

Cavitron®

FDA UDI
Dentsply Professional·D00388002041·Cavitron® integrated systems Built-In a-dec® Ul...

n.a.

FDA UDI
Karl Storz GmbH & Co. KG·04048551201244·Retractor, extra fine, 4 prongs, 13 cm

ACUMED

FDA UDI
Acumed LLC·10806378040443·Angled Drill Guide Assembly

NAR Kit

FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209100644·KIT, RAPID DEPLOYMENT-TACTICAL - DUC

Denovo Dental Posterior Band Remover Long

FDA UDI
Denovo Dental, Inc.·00810059291638·Denovo Dental Posterior Band Remover Long

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756015844·CUSTOM ARM SLING

WIN-1 TANGO

FDA 510(k)
FDA Class 2 ·Physical Medicine

VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 8, 2014

LIFEVEST WCD 3100 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 12, 2012

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·August 29, 2007

CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

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