20 results · 31ms · Sources: EU EUDAMED, US FDA

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VariLift-L Interbody Fusion Device

FDA 510(k)
FDA Class 2 ·Orthopedic

Ophthalmic Forceps

FDA UDI
KATENA PRODUCTS, INC.·00841668106198·CASTROVIEJO-COLIBRI FORCEPS

ProLift Lateral

FDA UDI
Life Spine, Inc.·00190837081256·

CASTROVIEJO NEEDLE HOLDER

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896017672·CASTROVIEJO NEEDLE HOLDER WITH LOCK STRAIGHT TU...

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575294329·Knee femur prosthesis trial - Endo Model Knee S...

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575294305·Knee femur prosthesis trial - Endo Model Knee S...

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575294343·Knee femur prosthesis trial - Endo Model Knee S...

LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 28 / B

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 31, 2024

II Ring Retractor

FDA UDI
Automated Medical Products Corp.·00810118341397·Malleable Retractor 3" x 6" with Protective Edge

ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR

FDA 510(k)
FDA Class 2 ·Ophthalmic

HAKKI URINARY CATHETER; SIZE 14, 16, 18, 20, 22, 24, 26 FRENCH

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

ACRYSOF

FDA Adverse Event
Injury ·ALCON RESEARCH LTD./HUNTINGTON·Product code HQL·October 6, 2014

VUE PACS

FDA Adverse Event
Death ·CARESTREAM HEALTH, INC.·Product code LLZ·June 5, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

BIPOLAR HEAD Ø 28X48

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code KWY·September 30, 2016

AIA-900

FDA Adverse Event
Malfunction ·TOSOH HI-TEC, INC.·Product code KHO·June 13, 2024

AIA-900

FDA Adverse Event
Malfunction ·TOSOH HI-TEC, INC.·Product code KHO·February 18, 2024

AIA-900

FDA Adverse Event
Malfunction ·TOSOH HI-TEC, INC.·Product code KHO·February 5, 2026

ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023