9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BACTTRAP
FDA 510(k)
FDA Class 2
·Anesthesiology
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113660·CYSTOTOME STRAIGHT 25GA
AMSINO MEDICAL USA
FDA Adverse Event
Other
·AMSINO MEDICAL USA·Product code FOZ·May 20, 2009
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 30, 2014
REPAIR TPS OSC SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·November 12, 2010
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·November 30, 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