8 results
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18ms
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Sources: EU EUDAMED, US FDA
CUSTOM UNIVERSAL CUTDOWN PREP TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MPOWRX SNORING SOLUTION
FDA 510(k)
FDA Class 2
·Dental
SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·May 9, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·October 23, 2012
MAGIC 3 FEMALE INTERMITTENT CATHETER
FDA Adverse Event
Malfunction
·ROCHESTER MEDICAL CORP.·Product code KOD·May 27, 2015
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
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