10 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CARE ETS
FDA 510(k)
FDA Class 2
·Physical Medicine
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496023036·MISS RELAX 100 SHEER, SIZE S, NERO, GRADUATED C...
AOS CANCELLOUS LOCKING SCREW 4.0mm x 36mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665008562·
NOMOS MOTORIZED CRANE II
FDA 510(k)
FDA Class 2
·Radiology
TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025
FDA 510(k)
FDA Class 1
·Ophthalmic
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·March 27, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·February 24, 2011
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008
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
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024