510(k) Clearances in 2018 — Page 53

3,062 510(k) clearances total

Browse FDA 510(k) clearances granted in 2018. RegDataLab tracks 3,062 510(k) clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances in 2018 (page 53 of 62)
510(k) clearancesDetails
K173678 — Diode Laser CapCosmo Far East Technology Limited Feb 28, 2018
K172868 — Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd. Feb 28, 2018
K173691 — Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation PackQuidel Corporation Feb 28, 2018
K173275 — OMNICHROMATokuyama Dental Corporation Feb 27, 2018
K173683 — LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN VerifiersDiaSorin, Inc. Feb 27, 2018
K180237 — Rezum SystemNxthera, Inc. Feb 27, 2018
K172042 — NeuroNav System, NeuroSmart SystemAlpha Omega Engineering , Ltd. Feb 27, 2018
K173746 — Activmotion RangeNewclip Technics Feb 27, 2018
K173324 — ALTA Anterior Cervical Interbody SpacerAstura Medical Feb 27, 2018
K171476 — SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)Awareness Technology, Inc. Feb 27, 2018
K173343 — Zygomatic Implant SystemSouthern Implants (Pty), Ltd. Feb 27, 2018
K172044 — Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action SCook Ireland, Ltd. Feb 27, 2018
K170623 — ACE Hemoglobin A1c (HbA1c) ReagentAlfa Wassermann Diagnostic Technologies, LLC Feb 27, 2018
K171797 — TRYPTIK2 C-Plate Anterior Cervical Plate SystemSpineart Feb 26, 2018
K180327 — Stryker iVAS 13g Bone Biopsy KitStryker Corporation Feb 26, 2018
K171637 — OpClear SystemCipher Surgical, Ltd. Feb 26, 2018
K171668 — Bluetooth blood pressure monitorVisiomed Group SA Feb 26, 2018
K172320 — Neurostructures Cavetto® Cervical Cage SystemNeurostructures, Inc. Feb 26, 2018
K172899 — Vygon PICCsVygon USA Feb 26, 2018
K170175 — ENDOSEAL MTAMaruchi Feb 26, 2018
K173643 — Trilor Disks, Blocks and ArchesBioloren S.R.L. Feb 24, 2018
K171869 — Sutter CURIS RF GeneratorSutter Medizintechnik GmbH Feb 23, 2018
K173077 — Cavetto-SA Cervical Cage SystemNeurostructures, Inc. Feb 23, 2018
K173569 — Ultrasound System 1300Bk Medical Aps Feb 23, 2018
K180130 — ELEOS™ Bipolar Acetabular SystemOnkos Surgical, Inc. Feb 23, 2018
K173863 — Ez3D-i /E3Ewoosoft Co., Ltd. Feb 23, 2018
K173689 — Ophthalmic Software Platform RXCanon Inc. -Medical Equipment Group Feb 23, 2018
K173693 — Orbitum Bone Staple Implant, X and VIOrthovestments, LLC Feb 23, 2018
K171671 — Prismaflex System 8.10Baxter Healthcare Corporation Feb 23, 2018
K173491 — RTS Lesser MTP Implant SystemIn2Bones USA, LLC Feb 23, 2018
K173320 — KLS Martin L1 MMF SystemKLS Martin L.P. Feb 23, 2018
K173224 — SPIN-SWISpintech, Inc. Feb 23, 2018
K173677 — InMode VLazeInmode MD , Ltd. Feb 23, 2018
K173493 — Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000STERIS Corporation Feb 23, 2018
K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)Alfa Scientific Designs, Inc. Feb 23, 2018
K172324 — Axiostat Chitosan Hemostatic DressingAdvamedica, Inc. Feb 23, 2018
K173468 — Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0Toshibamedical Systems Corporation Feb 23, 2018
K170540 — DM-DensityDensitas, Inc. Feb 23, 2018
K171601 — Ultraxx Nephrostomy Balloon CatheterCook Incorporated Feb 23, 2018
K173236 — Sentry IVC FilterNovate Medical , Ltd. Feb 22, 2018
K173381 — Nexxis ORBarco N.V. Feb 22, 2018
K173255 — Talon DistalFix Humeral NailOrthopedic Designs North America, Inc. Feb 22, 2018
K171994 — Silicone Peripherally Inserted Central Venous Catheter Set/TrayCook Incorporated Feb 22, 2018
K173490 — Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000)STERIS Corporation Feb 22, 2018
K173067 — LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC Feb 22, 2018
K173485 — Amsco Evolution Medium Steam SterilizerSTERIS Corporation Feb 22, 2018
K171576 — The Panthera Anti-Snoring X3 DevicePanthera Dental, Inc. Feb 22, 2018
K172541 — Medline Catheter Specimen CollectorMedline Industries, Inc. Feb 22, 2018
K173334 — SeaSpine Spinous Process SystemSeaSpine Orthopedics Corporation Feb 22, 2018
K171823 — U&U Indicator tape and stripU&U Medical Technology Co, Ltd. Feb 22, 2018
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