10 results
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26ms
·
Sources: EU EUDAMED, US FDA
CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ReLine
FDA UDI
Nuvasive, Inc.·00195377068682·RELINE C Screw, 3.5x44mm MA
Brigade
FDA UDI
Nuvasive, Inc.·00887517963550·Brigade Lateral Trial, 6x38x28mm 30°
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TROPAZONE CR
FDA 510(k)
FDA Unclassified
·Unknown
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 30, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC. USA·Product code LFR·October 26, 2007
ZERO-P CONVEX H6 PEEK
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code OVE·January 9, 2013
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