11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENTERON LIVER BIOPSY TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GC Initial™
FDA UDI
Gc America Inc.·J0228740621·GC Initial™ Ti Dentin DC3, 20g
GC Initial™
FDA UDI
Gc America Inc.·15400556704032·GC Initial™ AL Enamel Occlusal EO-17, 20g
iNSitu™ Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127021459·Face Changing Liner Trial Size 62/68 x 40mm ID
FORCEPS & HAMOSTATS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STERILE LABELS
FDA 510(k)ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 16, 2014
PUMP MMT-715LNAS PRDGM INS V2.1 SK EN
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·October 15, 2010
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code EZW·December 14, 2012
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation
FDA Enforcement
Class II
·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013