![]() PA de la Lande Saint Martin- 45 ruSE DECISION MADE: 16-DEC-21 Newclip Technics 510(k) NO: K202803(Traditional)ĪTTN: Gaelle LUSSORI PHONE NO : 33 2 28213712 ![]() Jiande CN 310000 510(k) SUMMARY AVAILABLE FROM FDA Shangshan Village, Yang Cunqiao ToSE DECISION MADE: 13-DEC-21 Jiande Chaomei Daily Chemicals Co.510(k) NO: K202794(Traditional)ĪTTN: Zhu Lipin PHONE NO : 86 18 858158190 Sao Paulo BR 04127 510(k) SUMMARY AVAILABLE FROM FDA Padre Machado, 82 SE DECISION MADE: 23-DEC-21 Strada Regina SE DECISION MADE: 20-DEC-21Ĭastel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDAĬarci Industria E Comercio De Apar510(k) NO: K202788(Traditional)ĪTTN: Orlando Orlandi PHONE NO : 55 11 33462100 ![]() Medacta International SA 510(k) NO: K202568(Traditional)ĪTTN: Stefano Baj PHONE NO : 41 91 6966060 Medolla IT I-41036 510(k) SUMMARY AVAILABLE FROM FDAĭEVICE: Mpact® 3D Metal Implants - DMLS Technology Strada Statale 12, n☁43 SE DECISION MADE: 10-DEC-21 Utrecht NL 3572 EL 510(k) SUMMARY AVAILABLE FROM FDAĮurosets S.r.l. Gildstraat 91a SE DECISION MADE: 22-DEC-21 MRIguidance B.V 510(k) NO: K202404(Traditional) Hong Kong CN 510(k) SUMMARY AVAILABLE FROM FDA Skypro Medical Supplies Company 510(k) NO: K202255(Traditional)Ĭ301, Tsing Yi Industrial Centre PSE DECISION MADE: 24-DEC-21 Powers PHONE NO : 561 8684600Ģ801 Juniper Street, Suite 2 SE DECISION MADE: 02-DEC-21įairfax VA 22031 510(k) SUMMARY AVAILABLE FROM FDA San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA 510(k) NO: K201764(Traditional)Īndover MA 01810 510(k) SUMMARY AVAILABLE FROM FDAĭEVICE: GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2Īccriva Diagnostics, Inc. Wenzhou CN 325699 510(k) SUMMARY AVAILABLE FROM FDAĭEVICE: Infinity Acute Care System (IACS) Monitoring Solutionĭraeger Medical Systems, Inc. No.380 Ningkang East Road, LechengSE DECISION MADE: 10-DEC-21 Kangfu Medical Equipment Factory 510(k) NO: K201600(Traditional)ĪTTN: Jixiang Zhang PHONE NO : 86 0577 55775583 Johns Hopkins Eastern Building SuiSE DECISION MADE: 03-DEC-21īaltimore MD 21218 510(k) SUMMARY AVAILABLE FROM FDAĭEVICE: Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 Therataxis, LLC 510(k) NO: K201435(Traditional)ĪTTN: Raghu Raghavan PHONE NO : 443 5629944 Via dell'Industria 12 SE DECISION MADE: 14-DEC-21Īrzegrande IT 35020 510(k) SUMMARY AVAILABLE FROM FDAĭEVICE: Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring SystemĬIRCA Scientific, LLC 510(k) NO: K200943(Traditional)ġ4 Inverness Drive East, Suite H-1SE DECISION MADE: 17-DEC-21Įnglewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA Vacutest Kima Srl 510(k) NO: K200932(Traditional) Repro-Med Systems, Inc., dba KORU 510(k) NO: K200176(Traditional)ĪTTN: Cynthia Lacatena PHONE NO : 845 4692042Ģ4 Carpenter Road SE DECISION MADE: 15-DEC-21Ĭhester NY 10918 510(k) SUMMARY AVAILABLE FROM FDA Valhalla NY 10595 510(k) SUMMARY AVAILABLE FROM FDAĭEVICE: FREEDOM Integrated Syringe Infusion System ![]() Perotti 18 SE DECISION MADE: 27-DEC-21īrescia IT 25125 510(k) SUMMARY AVAILABLE FROM FDAĭEVICE: Contour® next GEN Blood Glucose Monitoring SystemĪscensia Diabetes Care 510(k) NO: K193407(Traditional)ĪTTN: Colleen Burdel PHONE NO : 914 2962880ġ00 Summit Lake Drive SE DECISION MADE: 23-DEC-21 ![]() Ithaca NY 14850 510(k) SUMMARY AVAILABLE FROM FDAĬOPAN WASP S.r.l. Rheonix, Inc 510(k) NO: K193081(Traditional)ĪTTN: Richard Montagna PHONE NO : 607 2571242ġ0 Brown Road, Suite 103 SE DECISION MADE: 17-DEC-21 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINALĭECISIONS RENDERED DURING THE PERIOD December 2021ĭEVICE: Rheonix STI Tri-Plex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit, Rheonix Swab Specimen Collection Kit ![]()
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