18 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRU-MR LARYNGOSCOPE SET
FDA 510(k)
FDA Class 1
·Anesthesiology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810625231·ROTH PRESCRIPTION -. 022"
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040115548·ROTH PRESCRIPTION -. 022"
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496062523·RELAX UNISEX 70 OPEN TOE, SIZE XXL, ANTRACITE, ...
ADVANTAGE DRIVE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
BD SYRINGE 5ML S/T BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 5, 2025
BD SYRINGE 5ML S/T BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 11, 2025
BD SYRINGE 5ML S/T BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·June 11, 2025
BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 14, 2022
CORTSCR Ø4.5 L28 SST
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·April 17, 2013
WECK HEM-O-LOK ENDO APPLIER XL
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·March 21, 2011
BI-V ICD
FDA Adverse Event
MEDTRONIC, INC.·Product code LWS·June 7, 2008
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022