9 results · 17ms · Sources: EU EUDAMED, US FDA

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ORTHOKROME* ANTIPLASMIN

FDA 510(k)
FDA Class 2 ·Hematology

N/A

FDA UDI
Smith & Nephew, Inc.·00885554008562·SOD COUPLER CAMERA FLOAT-LOCK ...

XPI ANGLED ABUTMENTS

FDA 510(k)
FDA Class 2 ·Dental

SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PERCOR STAT DL 9.5 FR. 40 CC IAB

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·August 30, 1997

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 6, 2014

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·January 7, 2013

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 26, 2010

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