9 results
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19ms
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Sources: EU EUDAMED, US FDA
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
FDA 510(k)
FDA Class 2
·Dental
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
FDA 510(k)
FDA Class 2
·Immunology
LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD PHOENIX¿ NMIC-306
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·June 27, 2025
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·April 9, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 25, 2011
VITALITY VR
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
Bio-Med Patient Breathing Circuit Product NUmber: 3030-5 Labeled in part: ONE SET - SINGLE USE CATALOG NO. 3030-5 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx60'' 1-PRESSURE GAGE LINE 1/8''IDx72'' 1-PATIENT HOSE 22mmIDx6'' 1-EXHALATION VALVE w/COLLECTION HEAD 1-ADULT PRESSURE TEE w/CUFF 1-EXHALATION VALVE LINE 1/8''IDx72 2-ADAPTERS 22mmx22mm
FDA Recall
Terminated
·Bio-Med Devices, Inc.·Product code CBK·December 6, 2004
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