10 results
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18ms
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Sources: EU EUDAMED, US FDA
NIDEK RT-1200S (MARCO TRS-1200)
FDA 510(k)
FDA Class 1
·Ophthalmic
Mini Master Series
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746105609·DB BKT MINI MS HGW LL 1ST BIC 018 T-12 A+2 R=0
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantra QPlus System
FDA 510(k)
FDA Class 2
·Hematology
FORCE FX-8C GENERATOR (SHANGHAI)
FDA Adverse Event
Injury
·COVIDIEN LLC (SHANGHAI)·Product code GEI·June 20, 2014
RUSCH GREENSPEC FO LARYNGOSCOPE HANDLE
FDA Adverse Event
Malfunction
·TELEFLEX·Product code EQN·January 3, 2013
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·November 9, 2010
Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·July 6, 2016
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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