10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NAMIC ANGIOGRAPHIC SYRINGE
FDA 510(k)
FDA Class 2
·Cardiovascular
NOVEL DISPENSER/PACKAGE
FDA 510(k)
FDA Class 1
·Dental
Mic-Key* SF Over-the-Wire Stoma Measuring Device
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 21, 2014
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 19, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 14, 2012
8.0MM TI USS CANC POLYAXIAL SCREW 70MM THREAD LENGTH
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code MNH·March 10, 2023
8.0MM TI USS CANC POLYAXIAL SCREW 70MM THREAD LENGTH
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code MNH·March 10, 2023
EQUINOXE REVERSE SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·December 8, 2022
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