20 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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