9 results
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19ms
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Sources: EU EUDAMED, US FDA
CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)
FDA 510(k)
FDA Class 1
·Radiology
ERA ANGLE 3.25MM IMP MICRO HEAD 15X2MM ACID ETCHED, Ti0
FDA UDI
STERNGOLD DENTAL LLC·00841549109683·Designed for both transitional and long-term de...
STAR-LITE -LM, MODEL SL8809
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIQUICHEK LIPIDS CONTROL, MODEL 641, 642
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RSP SHOULDER
FDA Adverse Event
Injury
·ENCORE MEDICAL, L.P.·Product code KWS·June 30, 2014
X-STOP IPD SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SPINE LLC.·Product code NQO·October 22, 2010
SCREW
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·January 8, 2013
UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
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