12 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER
FDA 510(k)
FDA Class 1
·General Hospital
ACE
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950025527·TEMPLATE ACE TOOTH TRACING *COLD STERILIZE ONLY*
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032938·Baltic Denture System BDLoad Mw6 PLSEbim6DFm B4...
B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16
FDA 510(k)
FDA Class 2
·General Hospital
SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
FDA 510(k)
FDA Class 2
·Neurology
MEDFUSION 4000 WIRELESS SYRINGE INFUSION PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·October 20, 2022
PRISMAFLEX SETS (HF)
FDA Adverse Event
Death
·BAXTER HEALTHCARE CORPORATION·Product code KDI·May 22, 2023
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 3, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 29, 2011
BRAVO
FDA Adverse Event
Malfunction
·ARIZONA DEVICE MANUFACTURING·Product code FFT·April 23, 2008
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024