36 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEODENT IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Bur PM2-150 80K Diam Ø1.0 St
FDA UDI
Bien-Air Surgery SA·17630055515695·
Preat
FDA UDI
Preat Corporation·00842092107973·Preci Ball 22 Complete w/Threaded Male
DURAVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948005226·DURAVENT UNI 2 ICU, SIZE 7
TALOS®-C HA
FDA UDI
MEDITECH SPINE, LLC·B167521012070·
Biliary Drainage Tube
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046537·
eTRAX™ Needle
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436102350·Sterile needle, 12GA x 7cm with (7.6 tapered to...
eTRAX™ Needle
FDA UDI
CIVCO MEDICAL INSTRUMENTS CO., INC.·00841436102346·Sterile needle, 12GA x 7cm with (7.6 tapered to...
LASER PERIPHERALS REUSABLE HOLMIUM FIBER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
FDA 510(k)
FDA Class 2
·Ophthalmic
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 26, 2023
TGS UKA SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC·Product code HSX·March 22, 2013
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·May 6, 2013
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL, INC·Product code HSX·February 12, 2014
TGS UKA SYSTEM
FDA Adverse Event
Injury
·CAYENNE MEDICAL, INC.·Product code HSX·September 25, 2014
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 1, 2024
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·September 10, 2013
TGS UKA KNEE SYSTEM
FDA Adverse Event
Injury
·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·August 14, 2013
UNIFY QUADRA CRT-D, DF4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014