15 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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EZ-IO
FDA 510(k)
FDA Class 2
·General Hospital
OsteoMed
FDA UDI
OSTEOMED LLC·00845694091312·2.4mm x 8mm Fully Threaded Screw
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809848038·FOR MEN 15-20 MM HG KNEE HIGH CLOSED TOE LARGE-...
BD MAX¿ STAPHSR
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code NQX·September 14, 2023
BD MAX¿ STAPHSR
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code NQX·September 14, 2023
CEREC VITABLOCKS MK2
FDA 510(k)
FDA Class 2
·Dental
AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWP·September 3, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·April 11, 2013
TOTALCARE SPORT
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 16, 2011
FORCE FXC
FDA Adverse Event
COVIDIEN VALLEYLAB·Product code GEI·March 27, 2008
MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·April 13, 2022
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·October 30, 2024
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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