14 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BONE GRAFT WASHER, MODEL 9090114 - 9090118
FDA 510(k)
FDA Class 2
·Orthopedic
XLIF
FDA UDI
Nuvasive, Inc.·00887517803573·ALBINS Cobb, 22mm Bayoneted Inferior
INSYTE-A ARTERIAL CATHETERIZATION UNIT
FDA 510(k)
FDA Class 2
·General Hospital
LEECO VIS-DISK STREP-A (EIA)
FDA 510(k)
FDA Class 1
·Microbiology
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 7, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·July 14, 2010
TRANSEND GUIDEWIRE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 10, 2010
EMERGE¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·March 8, 2013
IMMAGE IMMUNOCHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JQX·February 16, 2011
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR, LLC·Product code OBR·July 24, 2014
TRANSEND GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MIAMI·Product code DQX·May 27, 2010
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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