16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Basic, Dominant Flex, KV-6
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AGXO
FDA UDI
Oticon A/S·05707131285669·H160V2, MINIRITE 312 WL SIL AGXO
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100073·TEMPORAL SPECULUM SOLID BLADES
NC TREK RX CORONARY DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ICC INSULIN SAFEPRO SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 12, 2025
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 28, 2016
HIRES 90K ADVANTAGE IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·May 30, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
8030916-2008-00029
FDA Adverse Event
Other
·Product code FSA·September 2, 2008
LOCKING SCREW AXSOS 3 TI 4.0MM / L36MM
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HRS·January 12, 2017
LOCKING SCREW AXSOS 3 TI 4.0MM / L46MM
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HRS·January 12, 2017
LOCKING SCREW AXSOS 3 TI 4.0MM / L48MM
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HRS·January 12, 2017
CORTEX SCREW AXSOS 3 TI Ø3.5MM / L36MM
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HRS·January 12, 2017
LOCKING SCREW AXSOS 3 TI 4.0MM / L42MM
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HRS·January 12, 2017
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024