34 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POLARCUP DUAL MOBILITY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Stryker
FDA UDI
Provision·B504OM1101350·
Mako
FDA UDI
MAKO SURGICAL CORP.·00848486016876·Ball Burr
NorthStar
FDA UDI
Seaspine Orthopedics Corporation·10889981259822·3.5mm Drill
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450048597·
SixFix Circular Fixation System
FDA UDI
ARROWHEAD DE LLC·00855967006509·Full Ring, 135mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450263785·
SixFix Circular Fixation System
FDA UDI
Amdt Holdings, Inc.·00850030203410·Full Ring, 135mm
Stage-1
FDA UDI
KEYSTONE DENTAL, INC.·D768S11013510K0·Drill
Stage-1
FDA UDI
KEYSTONE DENTAL, INC.·D768S11013516K0·Drill
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197539654·Caspar Laminectomy Ronguer upwards angle
d, 5x1...
3.5 x 230 mm Surgibit Drill
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215055097·The saleable unit (device count) is 1, there ar...
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
FDA 510(k)
FDA Class 2
·Physical Medicine
GDS-DC12
FDA 510(k)
FDA Class 2
·Cardiovascular
UNK SCREW
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code HWC·October 10, 2018
STD BRL LAG SCRW 12.5X120MM
FDA Adverse Event
Malfunction
·BIOMET UK LTD.·Product code HWC·October 10, 2018
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
STD BRL LAG SCRW 12.5X115MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSB·September 14, 2018
UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HWC·September 13, 2018
NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 13, 2013