12 results
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18ms
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Sources: EU EUDAMED, US FDA
MARK VII THERMOREGULATION ASSIST SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
n/a
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902411069·INSTRUMENT 2900355 14MM SHAVER
MAXFIRE CANNULA OBTURATOR
FDA UDI
Biomet Orthopedics, LLC·00880304463752·
M4-Left 16mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199003550·
PROCALLUS FIXATOR
FDA UDI
ORTHOFIX SRL·18053504369783·Spare part, not medical device, not for sale. R...
3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
OPAL SEAL
FDA 510(k)
FDA Class 2
·Dental
DURALOC CONST LINER 50X28
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.-1818910·Product code JDI·June 27, 2014
DIALYSIS IMPLANTED CATHETER
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code MSD·October 26, 2010
STARCLOSE SE VASCULAR CLOSURE SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·January 7, 2013
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·May 15, 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