12 results
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25ms
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Sources: EU EUDAMED, US FDA
HUMEROUS FRACTURE BRACE, ULNA FRACTURE
FDA 510(k)
FDA Class 1
·Physical Medicine
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58208017880·RETRACTOR, ALL TYPES
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450179734·
ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200
FDA 510(k)
FDA Class 2
·Cardiovascular
INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200
FDA 510(k)
FDA Class 2
·General Hospital
CMC-V GENERATOR ENGLISH
FDA Adverse Event
Malfunction
·SYNERGETICS INC. / CODMAN & SHURTLEFF, INC.·Product code GEI·April 10, 2017
SPECTRUN INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 8, 2014
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·October 23, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 27, 2007
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021