13 results
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31ms
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Sources: EU EUDAMED, US FDA
ACUCAM CONCEPT IV FWT, MODEL 110-0185G1
FDA 510(k)
FDA Class 1
·Dental
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032904·Baltic Denture System BDLoad Sm6 PLSEbm6DFs B3 ...
ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION
FDA 510(k)
FDA Class 2
·Hematology
WILLI GELLER CREATION AND LF PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
TEGO® CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·October 4, 2019
TEGO® CONNECTOR
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·October 4, 2019
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·April 3, 2013
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·March 29, 2011
PLUMSET-DUAL W/CON PP, CAP PORT & CLAVE
FDA Adverse Event
Malfunction
·HOSPIRA DE COSTA RICA LTD.·Product code FPA·April 23, 2008
Roche brand OMNI 1 Analyzer; catalog numbers GD0315 and GD0315R.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code JJE·December 29, 2003
SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02
FDA Enforcement
Class II
·Ongoing·Micromed S.p.A.·June 17, 2026
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