16 results
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19ms
·
Sources: EU EUDAMED, US FDA
KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Prehma
FDA UDI
Keystone Industries·H66879020001·Prehma Saliva Ejectors Wht/Wht Tip Case 10/100
30MM UNIFLOW COAXIAL BS WITH ELBOW INTEGRAL MONITORING LINE AND LIMB, 1.6M
FDA UDI
Intersurgical Incorporated·05030267065431·30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH ELBO...
Y-PIECE 15M, 15M, 15F
FDA UDI
Intersurgical Incorporated·05030267056118·Y-PIECE 15M, 15M, 15F
Nexalin
FDA UDI
NEXALIN TECHNOLOGY·B788KS02000·
Hydrate
FDA UDI
BRIVANT LIMITED·00816349011467·
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS;
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIBERTY CYCLER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·March 21, 2013
1.5MM X 10.0MM TAPERED ROUTER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·August 19, 2019
3.0MM CARBIDE MATCH HEAD
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·January 10, 2018
3.0MM CARBIDE MATCH HEAD
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·January 10, 2018
UNKNOWN_INSTRUMENTSTIRE_PRODUCT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code GFA·June 30, 2014
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 18, 2010
AUTOPULSE RESUSCITIATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·November 8, 2012
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