11 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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SCORPIO TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033972·Baltic Denture System BDLoad BDLoad Sw6 PLSEbm...
NUMED GHOST II PTA CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CANES
FDA Adverse Event
UNKNOWN·Product code IPS·April 3, 2013
UNKNOWN DEPUY GLOBAL FX STEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HSD·March 17, 2011
LASER
FDA Adverse Event
Injury
·Product code LZS·April 24, 2008
BD MICROTAINER® MAP MICROTUBE FOR AUTOMATED PROCESS K2 EDTA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JKA·July 3, 2019
TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
FDA Enforcement
Class II
·Terminated·ArthroCare Corporation·April 13, 2016
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