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

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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