11 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TrueView 100 Pro
FDA 510(k)
FDA Class 2
·Radiology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112823·BARRON VACUUM PUNCH 9.25MM
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113301·STAB KNIFE 45 DEGREE (BX/5)
Paramount IBF
FDA UDI
Seaspine Orthopedics Corporation·10889981041267·Fixed Trial; 27x13 (05-3513)
DFA RESPIRATORY VIRUS SCREENING & ID KIT
FDA 510(k)
FDA Class 1
·Microbiology
TIGER FLAT SURGICAL MASK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 27, 2014
ZENITH RENU
FDA Adverse Event
Other
·COOK MEDICAL·Product code MIH·July 28, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 2, 2013
RSP
FDA Adverse Event
Injury
·ENCORE MEDICAL L.P.·Product code PHX·August 26, 2022
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