9 results
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18ms
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Sources: EU EUDAMED, US FDA
ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GC Initial™
FDA UDI
Gc America Inc.·J0228730801·GC Initial™ AL Clear Window CL-W, 20g
ATTUNE PS RP INSRT SZ8 6MM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code NJL·December 17, 2025
QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)
FDA 510(k)
FDA Class 2
·Orthopedic
5MM, 33CM PEEK MONOPOLAR HANDLE 33CM
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code KOG·June 13, 2014
PUMP MMT-723PNAS PRDGM INS V2.3 SK EN PW
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·October 15, 2010
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·December 13, 2012
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
FDA Enforcement
Class II
·Terminated·Civco Medical Instruments Inc·July 18, 2012