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