8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR
FDA 510(k)
FDA Class 1
·Orthopedic
NILIMEDIX ADI
FDA 510(k)
FDA Class 2
·General Hospital
Gemini-C Hybrid Cervical Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
CRUCIFORM SCREWDRIVER SHAFT
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HXX·June 12, 2014
SPECTRANETICS LASER SHEATH II
FDA Adverse Event
Injury
·SPECTRANETICS CORP.·Product code MFA·October 6, 2010
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·December 12, 2012
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 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