22 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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