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

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VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG

FDA 510(k)
FDA Class 2 ·Hematology

Prodigy No Coding Blood Glucose Test Strips

FDA UDI
Prodigy Diabetes Care, LLC·00384840528253·1 Box of Prodigy No Coding Blood Glucose Test S...

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809846232·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE EXTRA LA...

MANUAL WHEELCHAIR

FDA 510(k)
FDA Class 1 ·Physical Medicine

HEARTTRENDS

FDA 510(k)
FDA Class 2 ·Cardiovascular

UNSPECIFIED SAFESET TRANSPAC SETS

FDA Adverse Event
Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025

OCTRODE

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·April 2, 2013

EASYTRAK

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code OJX·April 13, 2011

PUMP MMT-512LNAS PRDGM INS SK EN US LN

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code LZG·May 27, 2008

Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·August 8, 2012

HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

FDA Enforcement
Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

FDA Enforcement
Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

FDA Recall
Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

FDA Recall
Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

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