168 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE
FDA 510(k)
FDA Class 2
·Cardiovascular
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925012554·RICHARDS PISTON DEPTH GAUGE
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780378457·Integra® Jarit® Ferris-Smith Tissue Forceps, 6-...
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981175986·Z-Rod, Dia. 6.0mm, Titanium, 290mm
ESTEMP NE
FDA 510(k)
FDA Class 2
·Dental
PERIOLASE ND:YAG DENTAL LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·May 22, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 30, 2014
I-STAT ACTK (KAOLIN) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE CANADA LTD.,·Product code JJE·May 9, 2011
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 29, 2025
Single Shot Epidural Tray Catalog 1165
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers.
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Co. Inc.·November 25, 2015
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 15, 2024
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 19, 2021
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 19, 2021
CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 19, 2021
INSPIRE 7F M N/S
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA - S.R.L.·Product code DTZ·February 19, 2026
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 22, 2020
CAPIOX FX05
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 21, 2020
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 1, 2022