12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CEFALY Connected - OTC, CEFALY Connected - Rx
FDA 510(k)
FDA Class 2
·Neurology
Sonic
FDA UDI
Sbo Hearing A/S·05714464034628·Sonic SoundLink Connect 3.4.0 Android
ACCESS HIGH SENSITIVITY TROPONIN I REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·November 14, 2022
BELTER BLOOD PRESSURE METER
FDA 510(k)
FDA Class 2
·Cardiovascular
TI CLIP APPLIER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·November 10, 2023
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2014
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 6, 2011
OPEN SPINE CLAMP, TITANIUM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·July 18, 2013
ACCESS HIGH SENSITIVITY TROPONIN I REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·February 2, 2023
ACCESS HIGH SENSITIVITY TROPONIN I REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·September 6, 2022
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014