414 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ARTHREX COMPRESSION PLATES
FDA 510(k)
FDA Class 2
·Orthopedic
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776172510·FEILCHENFELD SPLINTER FCPS
LEONE SPA
FDA UDI
LEONE SPA·08033707010586·CALIBRA 1ST MOLAR BANDS n.UL 10
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450563311·
STILLE Osteotomes
FDA UDI
Stille AB·07332339206314·OSTEOTOME ORIGINAL STILLE delicate 10 mm 21 cm ...
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180517734·PLIF/TLIF Shaver w/T-Handle, 10mm
CERAMIR CROWN & BRIDGE
FDA 510(k)
FDA Class 2
·Dental
DEPILASE TWIN YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMAX 2 MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·May 24, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 30, 2014
EXTERNAL NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·June 14, 2011
INSTRUMENT TRACKER 9733533XOM ENT 1PK
FDA Enforcement
Class II
·Terminated·Medtronic Navigation, Inc.·November 26, 2014
CAPIOX®FX
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·February 19, 2026
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·June 9, 2022
CAPIOX®FX
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 30, 2026
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 6, 2025
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·August 25, 2021
CAPIOX FX25 OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·October 18, 2022
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·November 11, 2020
CAPIOX FX OXYGENATOR
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DTZ·September 9, 2024