14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Air Gap Fiber
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bernafon
FDA UDI
Sbo Hearing A/S·05714464033386·BERNAFON CROS MNR T R MAC
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112755·BARRON VACUUM PUNCH 7.5MM
Sklar®
FDA UDI
SKLAR CORPORATION·10649111288661·SKLARLITE HALSTED MOSQ CVD 5
INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
STARBOND DENTAL BONDING ALLOYS
FDA 510(k)
FDA Class 2
·Dental
TI TOMOFIX MEDIAL HIGH TIBIA PLATE-4 HOLES/SMALL
FDA Adverse Event
Injury
·SYNTHES HAGENDORF·Product code HRS·July 1, 2016
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 23, 2015
PUMP MMT-722NAL PRDGM INSULIN CL EN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·November 3, 2008
ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·September 1, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 40MM
FDA Adverse Event
Injury
·SYNTHES GRENCHEN·Product code KTT·July 1, 2016
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025