12 results
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18ms
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Sources: EU EUDAMED, US FDA
NCONTACT COAGULATION SYSTEM KIT, MODEL CSK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Trulife
FDA UDI
Trulife Limited·00645517612836·ActiveFlow External Breast Form Size 12
LEONE SPA
FDA UDI
LEONE SPA·08033707083702·ANATOMICAL EXPANDER ORTHOGONAL ARMS 12mm
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EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193104492·HA PEEK EVOS Curved, , 12mmx9mmx 30mm , BICONVE...
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0130120·Segmental Rod Reducer Driver
SMARTSET HV BONE CEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
RAICHEM PHOSPORUS REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·April 17, 2013
MULTIDIAGNOST ELEVA WITH FLAT
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code IZI·March 21, 2011
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 18, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015