34 results · 21ms · Sources: EU EUDAMED, 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