10 results
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22ms
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Sources: EU EUDAMED, US FDA
CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083010072·Fixed, 4 electrode, CS, 10mm electrode spacing
COMPRESS ANTI-ROTATION SPINDLES
FDA 510(k)
FDA Class 3
·Orthopedic
HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR
FDA 510(k)
FDA Class 1
·General Hospital
PATIENT MATCHED TMJ
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·June 30, 2014
DEXTRUS 4137
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·November 9, 2010
WECK HT APPLIER MED 8" CVD
FDA Adverse Event
Malfunction
·TELEFLEX·Product code FZP·January 3, 2013
CPS TIB SPINDLE LT 12X37X42MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 16, 2019
Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 6, 2016
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