14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809845303·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE MEDIUM K...
POWER SUPPLY / BATTERY CHARGER
FDA Adverse Event
Malfunction
·ELPAC·Product code IYN·March 28, 2011
POWER SUPPLY/BATTERY CHARGER
FDA Adverse Event
Malfunction
·ELPAC·Product code ITX·July 30, 2010
POWER SUPPLY/BATTERY CHARGER
FDA Adverse Event
Malfunction
·ELPAC·Product code ITX·June 25, 2010
BIOTOUCH MASSAGE THERAPY SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
SYNTHES USS (10.0MM SIDE OPENING SCREWS)
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN DEPUY AML HIP STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·April 11, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 2, 2014
TELIGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 13, 2011
PORTEX® ULTRAPERC® SINGLE DILATOR TUBE
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD; INC.·Product code JOH·October 17, 2019
PORTEX BLUE LINE ULTRA SUCTIONAID PERCUTANEOUS DILATION TRACHEOSTOMY KIT
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code JOH·October 14, 2019
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