24 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304425866·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1416400·14mm H x 16mm W x 40mm L x 0 degrees XLIF
Bracken Iris Forceps
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896104020·Bracken Iris Forceps Delicate Cross Serrated Cu...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X14164080·14mm H x 16mm x 40mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X141640120·14mm H x 16mm W x 40mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L141640120·14mm H x 16mm W x 40mm L XLIF Trial 12 degree L...
Chic
FDA UDI
Gc Orthodontics America Inc.·E53514164000101·CHIC ROTH 018/L4 -17T 0A 0D
Chic
FDA UDI
Gc Orthodontics America Inc.·D78814164000101·CHIC ROTH 018/L4 -17T 0A 0D
Chic
FDA UDI
Gc Orthodontics America Inc.·D78814164000201·CHIC MBT 018/L4 -12T 0A 0D
Chic
FDA UDI
Gc Orthodontics America Inc.·E53514164000201·CHIC MBT 018/L4 -12T 0A 0D
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION FLOW(R) - HELIOX
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2025
PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·December 14, 2017
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929035009·Corpectomy, 14Dx16Wx40H 0°
Matrixx System
FDA UDI
NEXXT SPINE, LLC·00889929035177·Corpectomy, 14Dx16Wx40H 6°
PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code NRY·December 8, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2011