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

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VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE

FDA 510(k)
FDA Class 2 ·Microbiology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517636157·CoRoent Ant TLIF PEEK, 11x13x30mm 15°

5530 7L SYRINGE

FDA UDI
HANS RUDOLPH, INC.·00817136021010·5530 SYR W/SMC ID TPR FM OUTLT

SILO

FDA UDI
AURORA SPINE, INC.·B5211133050·SILO, TAMP

PENUMBRA EMBOLIZATION COIL SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

ENOXAPARIN TEST CARD

FDA 510(k)
FDA Class 2 ·Hematology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2026

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·September 13, 2019

GRSPR,BLNT 3.4 MMSTR W/NR HNDL

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code NBH·May 10, 2021

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

LAMITRODE TRIPOLE 16

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 26, 2013

COATED VICRYL (POLYGLACTIN 910) SUTURE

FDA Adverse Event
Malfunction ·ETHICON INC·Product code GAM·June 3, 2011

CAPD DISCONNECT Y-SET, BULKPACK DISPOSABLE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·August 12, 2008

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·November 3, 2021

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·July 29, 2019

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·December 26, 2019

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·March 4, 2020

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 18, 2022

LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.

FDA Recall
Terminated ·Lighthouse For The Blind·Product code LRR·March 22, 2013

LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.

FDA Enforcement
Class III ·Terminated·Lighthouse For The Blind·April 17, 2013