10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IROOT SP
FDA 510(k)
FDA Class 2
·Dental
n/a
FDA UDI
Ortho Development Corporation·00822409075416·12/14 Press-Fit Broach 09x17
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014608303·ALLEN, STERIS-AMSCO 4" SOFTCARE
POWER TILT AND RECLINE SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations. The Chromophare surgical lights consist of a ceiling tube, SK Box swivel arm support, and a light head. The light head is mounted on a cardanic suspension unit and can be turned, swiveled and tilted in any direction. The spatial repositioning of the light head makes use of the 360 degree rotating swivel/horizontal arm. The 360 degree rotating spring arm is used to adjust the height. The light can be mounted in several configurations, such as a single/dual ceiling mount, a boom-integrated suspension mount, a wall mount, or a mobile roll stand.
FDA Enforcement
Class II
·Terminated·Stryker Communications·March 7, 2018
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·April 26, 2013
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 7, 2011
BALL NOSE GUIDE WIRE 100CM
FDA Adverse Event
Injury
·DEPUY ACE S.A. 'R.L.·Product code LXH·July 22, 2008
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NKB·October 18, 2017