9 results
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18ms
·
Sources: EU EUDAMED, US FDA
4 SURE TM COLOSTOMY POUCH
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
TENEX TX2 PROCEDURE PACK
FDA Adverse Event
Injury
·TRICE MEDICAL·Product code LFL·September 25, 2025
TANGO M2 BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
PTS PANELS MULTI-CHEMISTRY CONTROLS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BARDIA FOLEY CATHETER SILICONE COATED K922431
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code KOD·November 1, 2021
ARTICULEZE M HEAD 36MM +12
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 18, 2013
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·December 13, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 6, 2014
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