510(k) Clearances

174,759 clearances total

K242458 — ArgenZ MTZArgen Corporation Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241089 — KeyPrint KeyDenture BaseKeystone Industries Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240391 — MUTARS® femoral stem cemented 160 mm and 200 mmImplantcast GmbH Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241554 — Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242086 — MagDI System (MAG-01, DS-01)Gt Metabolic Solutions, Inc. Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240543 — Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)Medency S.R.L. Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242560 — Manual Wheelchair (SYIV100-CA9221)Foshan Shunkangda Medical Tech Co., Ltd. Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242589 — Scarlet® AL-TSpineart SA Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242995 — OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K234060 — KIDNEYvault Portable Renal Perfusion SystemParagonix Technologies Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242073 — STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KK Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240289 — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)Scivita Medical Technology Co., Ltd. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241876 — Vitesse (5.0)Varian Medical Systems Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243007 — CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241753 — Immediate Molar ImplantsBiomet 3i, LLC Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242829 — BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242513 — FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)Guangdong Optomedic Technologies, Inc. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241324 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241988 — ProSeal™ Closed System Bag AccessEpic Medical Pte. , Ltd. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242847 — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);DRTECH Corporation Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243012 — MIM – Symphony HDR FusionMim Software, Inc. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242183 — Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240865 — IDS-iSYS Free TestosteroneImmunodiagnostic Systems Limited Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243057 — TrueFit Bolus; TrueFlex BolusAdaptiiv Medical Technologies, Inc. Wed Oct 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241478 — Tri-Wedge PTA Scoring Balloon Dilatation CatheterBrosmed Medical Co., Ltd. Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K243209 — nordicMEDiVANordicneurolab AS Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242193 — Arm Type Blood Pressure Monitor (BPM82)Avita Corporation Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241758 — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003)Stryker Sustainability Solutions Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242099 — Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without NeedleSol-Millennium Medical, Inc. Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242250 — PuraStat3-D Matrix Europe SAS Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241398 — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd. Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241532 — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)Shanghai SeeGen Photoelectric Technology Co., Ltd. Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240506 — KARL STORZ HoldersKarl Storz Endoscopy America, Inc. Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241572 — ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)Siemens Medical Solutions USA, Inc. Tue Oct 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc. Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242058 — Digital Prism Correction Feature (DPCF)Apple, Inc. Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242157 — Anovo Surgical System (Model 6Ne)Momentis Surgical , Ltd. Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K222740 — Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inchSpeciality Fibres and Materials, Ltd. Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240029 — Zio AT® device (A100A1001)iRhythm Technologies, Inc. Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242554 — Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc. Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241170 — Dynamic TiBase; TRI ScrewsTalladium España, SL Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242266 — PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments Mon Oct 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242435 — Dental Barrier and SleevesWellmed Dental Medical Supply Co., Ltd. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K240844 — Spectral CT 7500 RTPhilips Medical Systems Technologies , Ltd. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242868 — Kinos Total Ankle SystemRestor3D Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K232994 — Vittra APS Unique FlowDentscare Ltda Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241959 — 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)3M Company Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene SutureSafepath Medical, Inc. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K242372 — Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc. Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
K241131 — edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCKEdelweiss Dentistry Products GmbH Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
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