22 results · 23ms · Sources: EU EUDAMED, US FDA

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BNA Platform

FDA 510(k)
FDA Class 2 ·Neurology

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113554·IMPLANT BLADE 5.2MM (BX/5)

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113257·VITRECTOMY KNIFE 25GA (BX/5)

ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE

FDA 510(k)
FDA Class 2 ·Cardiovascular

HRW-63-INT WRIST ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

6800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 5, 2011

XLD 110V LATIN AMERI

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD·Product code FRN·September 18, 2014

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 2, 2013

LINER: MPACT FLAT PE HC LINER Ø36/E

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·September 20, 2023

STEM: QUADRA-P COLLARED STD STEM SIZE 4

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

ATLAS GOLD

FDA Adverse Event
Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 3, 2025

IMPELLA

FDA Adverse Event
Death ·ABIOMED, INC. - 1220648·Product code OZD·February 2, 2026

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 16, 2025

AMISTEM-P COLLARED STD STEM SIZE 6

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 29, 2024

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2024

M-VIZION FEMORAL REVISION SYSTEM

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·May 23, 2025

GAMMA4 - RC LAG SCREW D10.5X90MM

FDA Adverse Event
Malfunction ·STRYKER GMBH·Product code HSB·July 22, 2025

GAMMA4 - RC LAG SCREW D10.5X85MM

FDA Adverse Event
Malfunction ·STRYKER GMBH·Product code HSB·July 22, 2025

ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

FDA Enforcement
Class I ·Terminated·Oscor, Inc.·July 19, 2017