29 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Ultrasound System SONIMAGE HS1
FDA 510(k)
FDA Class 2
·Radiology
CoRoent
FDA UDI
Nuvasive, Inc.·00887517231710·CoRoent XLW 15°, 10x22x60mm
NuVasive
FDA UDI
Nuvasive, Inc.·00887517291080·CoRoent XL-XW, 10x24x60mm 10°
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704282894·HIBBS RETRACTOR 9 1/2" 26 x 75 MILLIMETER
AGC TRADITION KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304240735·
Precontoured Rod Ø5.5 mm x60 mm Package
FDA UDI
XENCO MEDICAL LLC·B064XM21510601·
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100172·KRATZ WIRE SPECULUM WITH WINGS
GLIDESHEATH
FDA UDI
TERUMO MEDICAL CORPORATION·00389701009933·GLIDESHEATH Nitinol Hydrophilic Coated Introduc...
Ø5.5mm X 60mm PRECONTOURED RODS
FDA UDI
XENCO MEDICAL LLC·B064XMPH21510602·
ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523103959·T³ Acetabular Hemispherical Shell, No Hole, 60mm
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·July 2, 2024
GLIDESHEATH SLENDER NITINOL
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·November 12, 2020
NA
FDA UDI
Exactech, Inc.·10885862523242·TRUL UNIVERSAL FEM TRIAL SIZE 6
ACCENT SR RF CUS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code DXY·January 13, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013
AUGMENTED INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. DEPUY-RAYNHAM·Product code KWA·June 30, 2011
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·June 13, 2024
LIFE SCOPE G9
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·October 27, 2023