10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNERMED ALBUMIN REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Brigade
FDA UDI
Nuvasive, Inc.·00887517963543·Brigade Lateral Trial, 14x38x28mm 25°
STRYKER PAINPUMP PCA
FDA 510(k)
FDA Class 2
·General Hospital
CHLAMYDIAZYME DIAGNOSTIC KIT
FDA 510(k)
FDA Class 1
·Microbiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 30, 2014
XRL MEDIUM SCREW F/END-PL 2U
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code MQP·January 9, 2013
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC. USA·Product code LFR·October 26, 2007
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
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