9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CORPAK-ENTERAL FEEDING CONTAINER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code OVD·December 16, 2022
AT HOME OVULATION TEST, MODEL 9032
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ASAHI REXEED-SX/LX SERIES DIALYZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP.·Product code MKJ·April 25, 2014
PULSAR GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·August 25, 2010
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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