1,271 results · 25ms · Sources: EU EUDAMED, US FDA

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Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen BRAF V600E RGQ PCR Kit

Somatic Gene Mutation Detection System

FDA Pre-Market Approval
FDA Class 3 ·therascreen BRAF V600E RGQ PCR Kit

Osia 2(I) SP Magnet strength 4(I)

FDA UDI
COCHLEAR LIMITED·09321502070980·

PILLING

FDA UDI
TELEFLEX INCORPORATED·34026704652793·

Greenwald Surgical Company, Inc.

FDA UDI
GRACE MANUFACTURING, INC.·10801334008567·Otis Bougie-a-Boule. Mirror finish, stainless s...

Q-Rejuvalight Pro Facewear

FDA UDI
Light Tree Ventures Europe B.V.·08719327598719·

Q-Rejuvalight Pro Facewear (Model: P19-0023)

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

Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)

FDA 510(k)
FDA Class 2 ·Anesthesiology

AXONICS

FDA Adverse Event
Injury ·AXONICS MODULATION TECHNOLOGIES, INC.·Product code EZW·June 3, 2025

AXONICS

FDA Adverse Event
Injury ·AXONICS MODULATION TECHNOLOGIES, INC.·Product code EZW·June 4, 2025

AXONICS

FDA Adverse Event
Injury ·AXONICS MODULATION TECHNOLOGIES, INC.·Product code EZW·June 3, 2025

AXONICS

FDA Adverse Event
Injury ·AXONICS MODULATION TECHNOLOGIES, INC.·Product code EZW·June 3, 2025

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval
FDA Class 3 ·NEUROPACE RNS SYSTEM

P2psa

FDA Pre-Market Approval
FDA Class 3 ·ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS

AXONICS

FDA Adverse Event
Injury ·AXONICS MODULATION TECHNOLOGIES, INC.·Product code EZW·June 24, 2025

AXONICS

FDA Adverse Event
Injury ·AXONICS MODULATION TECHNOLOGIES, INC.·Product code EZW·June 5, 2025

AXONICS

FDA Adverse Event
Injury ·AXONICS MODULATION TECHNOLOGIES, INC.·Product code EZW·January 23, 2026

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT

FDA Enforcement
Class II ·Ongoing·Covidien, LP·April 10, 2024

AXONICS

FDA Adverse Event
Injury ·AXONICS MODULATION TECHNOLOGIES, INC.·Product code EZW·October 9, 2025

AXONICS

FDA Adverse Event
Injury ·AXONICS MODULATION TECHNOLOGIES, INC.·Product code EZW·September 4, 2025