13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MR Diffusion Perfusion Mismatch V1.0
FDA 510(k)
FDA Class 2
·Radiology
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551077559·HUGHES Elevator, 0.7 mm
Symmetry Volkman
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482059616·Symmetry® Retractor, Volkman, Blunt, 2-Prong, 8...
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776322908·Sinus Curette
GLOBAL
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295105367·GLOBAL ORIGINAL BROACH HANDLE
JEWEL CAST PLUS
FDA 510(k)
FDA Class 2
·Dental
MEDO-Thyroid
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 6, 2014
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026