13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ceribell Status Epilepticus Monitor
FDA 510(k)
FDA Class 2
·Neurology
SMARTLOCK
FDA UDI
Stryker Leibinger GmbH & Co. KG·34546540355851·Locking Screws, Cross-Pin
Symmetry Volkman
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482044889·Symmetry® Retractor, Volkman, Blunt, 4-Prong, 8...
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Cios Flow
FDA 510(k)
FDA Class 2
·Radiology
Power cord for Q2 Continuous Cardiac Output (CCO)/SO2 Computer, list #s 52235-04-01, 52235-04-03, 52236-04-05, 52235-04-07, 52235-04-11, AC cord manufactured by Electri-Cord, Westfield PA, Infusion pumps manufactured by Hospira, Morgan Hill, CA.
FDA Recall
Terminated
·Hospira Inc·Product code dxg·August 11, 2009
RIATA PASSIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Malfunction
·ETHICON INC·Product code FTL·August 25, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 12, 2013
IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·January 13, 2023
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
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