14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DORC VITRECTOMY LENSES, MODEL 1284 SERIES
FDA 510(k)
FDA Class 2
·Ophthalmic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033950·Baltic Denture System BDLoad BDLoad Mm6 PLSEbi...
Masterline
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746164583·INSTRUMENT MASTERLINE MINI PIN AND LIGATURE CUTTER
VENTED VIAL ACCESS DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
VIDAS TROPONIN I (TNI), MODEL 30 445
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INTRACRANIAL PRESSURE / TEMPERATURE MONITORING KIT
FDA Adverse Event
Malfunction
·NATUS MEDICAL INCORPORATED·Product code GWM·June 17, 2021
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 8, 2023
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 3, 2013
SAGITTAL SAW ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·March 23, 2011
ELITE MODULAR HD 32MM +3
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code JDI·April 24, 2008
COMPACT PORTABLE NEUROMONITOR (ICP AND ICT)
FDA Adverse Event
Malfunction
·NATUS MEDICAL INCORPORATED·Product code GWM·December 23, 2020
EXT CABLE (FIBEROPTIC CATHETERS TO CAMINO MONITOR)
FDA Adverse Event
Malfunction
·NATUS MEDICAL INCORPORATED·Product code GWM·November 4, 2022
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