9 results
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25ms
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Sources: EU EUDAMED, US FDA
LIQUI-URA CHEMISTRY URINE CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MONDEAL
FDA UDI
MONDEAL Medical Systems GmbH·04050435064203·MCD Screw 4.0 x 18 mm M3
non lo...
LED TURBO
FDA 510(k)
FDA Class 2
·Dental
Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·May 30, 2014
PENTAX
FDA Adverse Event
Malfunction
·PENTAX MEDICAL COMPANY·Product code EOQ·October 24, 2012
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·September 17, 2010
Presource PBDS, Gyn Laparoscopy Kit, Circulator
FDA Enforcement
Class I
·Terminated·Cardinal Health, Medical Products & Services·May 15, 2013
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017