9 results
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18ms
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Sources: EU EUDAMED, US FDA
PROPHY ANGLE
FDA 510(k)
FDA Class 1
·Dental
FORERUNNER AED, US ENGLISH, REFURB
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS (HTST RETURNS)·Product code MKJ·May 31, 2012
LIGHTSHEER DUET LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ROSC-U Mini Chest Compressor (RMCC)
FDA 510(k)
FDA Class 2
·Cardiovascular
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 9, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 10, 2011
ACCU-CHEK ® AVIVA COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·July 23, 2014
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024
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