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

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BRAINLAB KNEE

FDA 510(k)
FDA Class 2 ·Neurology

N/A

FDA UDI
GEORGE TIEMANN & CO.·B58211029900·HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540134585·ARCH BAR, ERICH, ROLL

EVOLUT FX VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 28, 2025

Recon

FDA UDI
Revelation Medical Devices·G31810299004·T Skid Retractor

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450320808·

LINEAR ST

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 5, 2022

COLLATEK POWDER

FDA 510(k)
FDA Unclassified ·Unknown

VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001

FDA 510(k)
FDA Class 2 ·Neurology

POWER DRIVE

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code GEY·May 9, 2013

OXFORD UNI TIBIAL TRAY SZA LM/RL PMA

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code HRY·September 19, 2014

INTEGRITY RX CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code MAF·May 12, 2011

XP-XP Tibial Tray - Interlok 63 mm Item # 195751

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Model Number L211 PROPONENT DR SL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Hemodialysis Delivery System, Software Version 2.x.

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021