10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CLARKE LAPAROSCOPIC LIGATOR AND FORCEPS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Brigade
FDA UDI
Nuvasive, Inc.·00887517963710·Brigade Lateral Trial, 13x38x32mm 8°
Sklar®
FDA UDI
SKLAR CORPORATION·10649111191923·LASER STEINER AUVARD SPEC
MAR COR SERVICES BICARB SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
UPCERA ZIRCONIA BLANKS
FDA 510(k)
FDA Class 2
·Dental
530G INSULIN PUMP
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·June 30, 2014
PULSE GEN MODEL UNK
FDA Adverse Event
Death
·CYBERONICS, INC.·Product code LYJ·January 9, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 16, 2010
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
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021