15 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Medline ReNewal Reprocessed Endopath Endoscopic Instruments
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
2.0 LACTOSORB SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036055165·
PATRIOT TRANSCONTINENTAL M SPACERS
FDA 510(k)
FDA Class 2
·Orthopedic
STIMUPLEX HNS-12, MODEL 4892098
FDA 510(k)
FDA Class 2
·Anesthesiology
UNKNOWN GAMMA3 LONG NAIL
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·March 9, 2021
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 7, 2013
ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)
FDA Adverse Event
Malfunction
·ANGIOSCORE, INC.·Product code LIT·October 3, 2014
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·June 23, 2011
UNKNOWN GAMMA3 SHORT NAIL
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·March 9, 2021
UNKNOWN GAMMA3 LONG NAIL CASE 3
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·March 9, 2021
UNKNOWN GAMMA3 LONG NAIL CASE 2
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·March 9, 2021
UNKNOWN GAMMA3 LONG NAIL CASE 1
FDA Adverse Event
Injury
·STRYKER TRAUMA KIEL·Product code HSB·March 9, 2021
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·June 23, 2025
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024