9 results · 27ms · Sources: EU EUDAMED, US FDA

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PRESSURE INFUSION PUMP

FDA 510(k)
FDA Class 1 ·General Hospital

Pediatric Forceps - #27 Molar Bird Beak

FDA UDI
Denovo Dental, Inc.·00810059291935·Pediatric Forceps - #27 Molar Bird Beak

Bioplate®

FDA UDI
Bioplate, Inc.·M3848131050·1.5mm diam. Plate & Screw Container

Mimics Medical

FDA 510(k)
FDA Class 2 ·Radiology

TEMPUSIC PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

PLATE

FDA Adverse Event
Injury ·DEPUY SYNTHES·Product code HRS·May 15, 2014

SPRINT QUATTRO SECURE S

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012

DELTA

FDA Adverse Event
Malfunction ·DRAGER MEDICAL SYSTEMS, INC. (IT/M)·Product code MHX·August 18, 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