14 results · 18ms · Sources: EU EUDAMED, 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