10 results · 18ms · Sources: EU EUDAMED, US FDA

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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