11 results · 29ms · Sources: EU EUDAMED, US FDA

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WMT COMPOSITE DBM

FDA 510(k)
FDA Class 2 ·Orthopedic

PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067

FDA 510(k)
FDA Class 2 ·Radiology

SAS STREPALERT

FDA 510(k)
FDA Class 1 ·Microbiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2025

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 9, 2024

BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·April 29, 2013

RESERVOIR 3CC

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·April 13, 2011

LIGAMAX-5MM ENDO CLIP APPLIER

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC·Product code FZP·July 29, 2008

Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S

FDA Enforcement
Class II ·Terminated·Stryker GmbH·July 18, 2018

Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S

FDA Enforcement
Class II ·Terminated·Stryker GmbH·July 18, 2018

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