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

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QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS

FDA 510(k)
FDA Class 2 ·Immunology

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X1416550·14mm H x 16mm W x 55mm L x 0 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X14165580·14mm H x 16mm W x 55mm L x 8 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X141655120·14mm H x 16mm W x 55mm L x 12 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587L141655120·14mm H x 16mm W x 55mm L XLIF Trial 12 degree L...

FLAATZ 760

FDA 510(k)
FDA Class 2 ·Radiology

BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)

FDA 510(k)
FDA Class 2 ·Dental

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 5, 2020

Matrixx System

FDA UDI
NEXXT SPINE, LLC·00889929065648·Corpectomy, 14Dx16Wx55H 6°

Matrixx System

FDA UDI
NEXXT SPINE, LLC·00889929065358·Corpectomy, 14Dx16Wx55H 0°

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2025

GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/12 MM RIGHT

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 17, 2017

BD SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 19, 2019

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 3, 2019

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 4, 2019

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FPA·June 27, 2011

RESERVOIR 1.8ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 4, 2014

BD AffirM VPIII Microbial Identification Test

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·March 8, 2017

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 24, 2019