10 results · 26ms · Sources: EU EUDAMED, US FDA

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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