20 results
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20ms
·
Sources: EU EUDAMED, US FDA
WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Safco D1amond
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063750920·Sterile Single Use Burs - ISO Code368-023C
Humeris Shoulder
FDA UDI
FX SOLUTIONS·03701037304228·TRIAL CENTERED SPACER Ø39 +3 mm 0°
Oscar 2
FDA UDI
SUNTECH MEDICAL, INC.·10840935102847·
FLEXMATE K500
FDA Adverse Event
Malfunction
·KLC, 4038 WEAVER COURT E., HILLIARD, OH 43026·Product code BXB·August 12, 2023
DOCXS B SERIES ELECTRODES
FDA 510(k)
FDA Class 2
·Neurology
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, VERSION 2
FDA 510(k)
FDA Class 2
·Orthopedic
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 9, 2018
BIPAP PRO
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·June 2, 2025
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code DYE·March 25, 2020
MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·May 4, 2020
AVALUS AORTIC TISSUE VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·June 23, 2020
VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LTJ·March 27, 2013
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·March 18, 2011
COLLEAGUE 3 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·October 26, 2021
BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·October 18, 2021
MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code KRH·July 19, 2022
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
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