17 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Umbilical Vessels Catheter
FDA 510(k)
FDA Class 2
·General Hospital
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446838043·SPECIAL, EMPOWR REV KNEE MONOBLOCK TIBIAL TRAY ...
NA
FDA UDI
Synthes GmbH·10886982142634·2.4MM CORTEX SCREW 3.5MM HEAD/SELF-TAPPING 54MM
CODMAN
FDA UDI
Cerenovus, Inc.·10886704001720·CODMAN SLIM-LINE Aneurysm Clip 90 Degree Angle ...
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENSITE VERISMO SEGMENTATION TOOL V.2.0
FDA 510(k)
FDA Class 2
·Radiology
PHYSICA
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code JWH·May 13, 2025
EVOLUT R TRANSCATHETER AORTIC VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·December 7, 2016
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
POPULAR PLASTICS·Product code IKX·October 27, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·June 28, 2013
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·January 4, 2012
UNKNOWN CAGE/SPACER
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code MAX·August 2, 2021
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
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
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025