29 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FOB ONE STEP RAPID TEST
FDA 510(k)
FDA Class 2
·Hematology
Humelock II Cemented Shoulder System
FDA UDI
FX SOLUTIONS·03701037301135·HUMELOCK II STEM TA6V SIZE 09 CEMENTED
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345024045·Paddle Shaver, 9mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0103090·Shaver, Closed, 9mm
EXELINT ALUMINUM HUB BLUNT NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR
FDA 510(k)
FDA Unclassified
·Unknown
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K1100090·Tray Insert 2, Cosmolock, Arcamed
Navagio
FDA UDI
Kalitec Direct LLC·B07330K1100090·Tray Insert
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K1100090·Tray Insert
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011030905600·HXLP LINER, 36MM I.D. X 56MM O.D., 0 DEG., +4MM
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011030905400·HXLP LINER, 36MM I.D. X 54MM O.D., 0 DEG., +4MM
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011030905800·HXLP LINER, 36MM I.D. X 58MM O.D., 0 DEG., +4MM
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011030906200·HXLP LINER, 36MM I.D. X 62MM O.D., 0 DEG., +4MM
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011030906400·HXLP LINER, 36MM I.D. X 64MM O.D., 0 DEG., +4MM
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011030906000·HXLP LINER, 36MM I.D. X 60MM O.D., 0 DEG., +4MM
Iconacy i-Hip
FDA UDI
Iconacy Orthopedic Implants LLC·M914011030905200·HXLP LINER, 36MM I.D. X 52MM O.D., 0 DEG., +4MM
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015
EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·July 30, 2014
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013