21 results · 22ms · Sources: EU EUDAMED, US FDA

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STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS

FDA 510(k)
FDA Class 2 ·Dental

Centaur Pedicle Screw System

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215126919·

RONGEUR MINI FRIEDMAN-5"

FDA UDI
W.H. Holden, Inc.·D928100825450·

GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ARAMIS DERMATLOGIC LASER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

ASAHI REXEED-LX SERIES DIALYZER

FDA Adverse Event
Injury ·ASAHI KASEI MEDICAL CO., LTD.·Product code KDI·May 4, 2012

ALTRX +4 10D 32IDX52OD

FDA Adverse Event
Injury ·JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD·Product code LPH·April 29, 2013

CORE IMPACTION DRILL

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·April 28, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 23, 2008

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 20, 2017

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·November 10, 2017

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·September 17, 2020

UNFOLDER PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·August 9, 2021

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·ABBOTT MEDICAL OPTICS·Product code KYB·March 24, 2016

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code KYB·April 4, 2018

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 24, 2018

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·JOHNSON AND JOHNSON SURGICAL VISION, INC.·Product code KYB·April 2, 2018

CORIN METAFIX HIP STEM

FDA Adverse Event
Injury ·CORIN MEDICAL·Product code LZO·September 6, 2022

PLATINUM 1 SERIES

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·January 11, 2021

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014