28 results · 24ms · Sources: EU EUDAMED, US FDA

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FOCAL SIM

FDA 510(k)
FDA Class 2 ·Radiology

Diamond D

FDA UDI
Keystone Industries·H66810131121·Denture Acrylic HC Dk Veined 1 lb P&L

BETHENNY EYEWEAR

FDA UDI
FGX INTERNATIONAL INC.·00193033457009·

BETHENNY EYEWEAR

FDA UDI
FGX INTERNATIONAL INC.·00193033457054·

BETHENNY EYEWEAR

FDA UDI
FGX INTERNATIONAL INC.·00193033457016·

BETHENNY EYEWEAR

FDA UDI
FGX INTERNATIONAL INC.·00193033456996·

BETHENNY EYEWEAR

FDA UDI
FGX INTERNATIONAL INC.·00193033457047·

BETHENNY EYEWEAR

FDA UDI
FGX INTERNATIONAL INC.·00193033457023·

BETHENNY EYEWEAR

FDA UDI
FGX INTERNATIONAL INC.·00193033457030·

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0130120·Segmental Rod Reducer Driver

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0131100·Assembly, Rod Inserter, Fixed UNID

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0131100·Rocker, One Piece

INSET GUARD

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·October 30, 2025

BIPOLAR COAGULATION SYSTEM

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

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SureCore Automatic Disposable Biopsy Needle

FDA UDI
Canyon Medical Inc.·06954414659283·Automatic Disposable Biopsy Needle

ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

FDA Adverse Event
Injury ·COOK, INC.·Product code MIH·September 4, 2014

EQUINOXE

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·June 2, 2021

CONSTELLATION VISION SYSTEM

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·March 15, 2013

ASR ACETABULAR IMPLANT 56

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011