11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Flex-ThreadTM Distal Fibula Intramedullary Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112519·BARRON VACUUM TREPHINE 8.0MM
XIA SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
XIA SCREW 6, 5 X 40
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
BABY LOG
FDA Adverse Event
DRAEGER MEDICAL AG & CO. KGAA·Product code CBK·September 25, 2008
S40 STERILANT CONCENTRATE
FDA Adverse Event
STERIS CORPORATION - HOPKINS·Product code MED·July 2, 2013
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021