12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIGITEX SUTURE DELIVERY SYSTEM, MODEL 52025, DIGITEX SUTURE CARTRIDGE (SIZE O), MODEL 52026, DIGITEX SUTURE CARTRIDGE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127130·AK3 PS Insert Trial Size 1, 12mm
FOCAL SIM
FDA 510(k)
FDA Class 2
·Radiology
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BZE·December 22, 2009
ADULT BREATHING CIRCUIT DUAL HEATED
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 15, 2007
TI LCP(TM) DISTAL FEMUR PLATE 13 HOLES/316MM-LEFT
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·December 26, 2018
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013
CUSTOM PACK
FDA Adverse Event
Malfunction
·DATASCOPE CORP·Product code DTR·August 21, 2014
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2011
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018