29 results · 29ms · Sources: EU EUDAMED, 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