8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PASCAL STREAMLINE PHOTOCOAGULATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT
FDA 510(k)
FDA Class 2
·Cardiovascular
GLUCOSURE BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
5MM, 33CM L-TIP ELECTROSURGICAL PROBE (3BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code GCJ·May 3, 2013
E360 VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·August 19, 2014
NEXGEN STEMMED TIBIAL COMPONENT
FDA Adverse Event
Injury
·ZIMMER INC·Product code JWH·May 10, 2011
MANTIS REDUX BLOCKER
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code NKB·November 27, 2019
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