12 results
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27ms
·
Sources: EU EUDAMED, US FDA
MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH
FDA 510(k)
FDA Class 1
·Dental
ReLine
FDA UDI
Nuvasive, Inc.·00195377068514·RELINE C Screw, 3.5x10mm MA
Brigade
FDA UDI
Nuvasive, Inc.·00887517963215·Brigade Lateral Trial, 8x38x28mm 12°
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837014315·
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613120511·PRYOR PEAN RETRACTOR
INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
FDA 510(k)
FDA Class 2
·Radiology
LUMENVU CATHETER GUIDANCE SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·April 5, 2022
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 30, 2014
HANDLE WITH QUICK COUPLING, SMALL
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·January 9, 2013
NXSTAGE SYSTEM ONE
FDA Adverse Event
Injury
·NXSTAGE MEDICAL, INC.·Product code KDI·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