14 results
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34ms
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Sources: EU EUDAMED, US FDA
PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.
FDA 510(k)
FDA Class 2
·Radiology
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013387·Post Op Telescoping Knee Brace
ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH SINGLE PEDAL MODEL WB50403W, P-CORD MODEL MAJ
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PERI-LOC BONE PLATING AND SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
Zimmer, Inc.·00889024133068·
NA
FDA UDI
Zimmer, Inc.·00889024133051·
NA
FDA UDI
Zimmer, Inc.·00889024133044·
NA
FDA UDI
Zimmer, Inc.·00889024133020·
NA
FDA UDI
Zimmer, Inc.·00889024133037·
SAW BLADE
FDA Adverse Event
Injury
·MAKO·Product code GFA·May 5, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 26, 2007
DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·May 28, 2015
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
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018