10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ORTHOKROME* HEPARIN
FDA 510(k)
FDA Class 2
·Hematology
APNOESCREEN PRO, ALPHA SCREEN PRO
FDA 510(k)
FDA Class 2
·Anesthesiology
Insight Enhanced DRF Digital Imaging System
FDA 510(k)
FDA Class 2
·Radiology
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 6, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 16, 2010
SROM*STM ST,30+4L NK,16X11X150
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code JDI·January 7, 2013
SMR SHOULDER SYSTEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·January 29, 2026
SMR REVERSE HUMERAL BODY
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code KWS·November 23, 2020
SMR GLENOID PEG TT SMALL-R #L
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWS·October 5, 2020
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