510(k) Clearances — Page 126

176,223 clearances total

Browse all FDA 510(k) medical device clearances. RegDataLab tracks 176,223 clearances from official FDA sources, updated on an ongoing basis.

510(k) Clearances (page 126 of 3,525)
ClearancesDetails
K241992 — Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. Oct 28, 2024
K242622 — Sterile Lancets for Single UseNingbo Caremed Medical Products Co., Ltd. Oct 28, 2024
K242350 — Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc. Oct 28, 2024
K242969 — Pantera Pro; Pantera LEOBiotronik, Inc. Oct 25, 2024
K240918 — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for AstigmatismBruno Vision Care, LLC Oct 25, 2024
K240092 — Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504)Shenzhen Yimi Life Technology Co., Ltd. Oct 25, 2024
K243070 — Xpert® SA Nasal CompleteCepheid® Oct 25, 2024
K243189 — TumorSight VizSimBioSys, Inc. Oct 25, 2024
K242625 — Freeze Point & Private Label VersionsCryoconcepts LP Oct 25, 2024
K240223 — FMT Disposable and Autoclavable Temperature ProbesMetko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi Oct 25, 2024
K243031 — LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd. Oct 25, 2024
K242397 — LYNX PhotocoagulatorNorlase Aps Oct 25, 2024
K243173 — Salto Talaris Ankle PSI System3D Systems, Inc. Oct 25, 2024
K243030 — Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)Ulike Co., Ltd. Oct 25, 2024
DEN230084 — Dexter L6 SystemDistalmotion SA Oct 25, 2024
K242215 — Neurophet AQUA (V3.1)Neurophet., Inc. Oct 25, 2024
K242353 — QIAstat-Dx Respiratory Panel MiniQIAGEN GmbH Oct 25, 2024
K243174 — Cadence Ankle PSI System3D Systems, Inc. Oct 25, 2024
K242956 — LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety NeedleOcuject, LLC Oct 25, 2024
K241185 — CORGRIP* SR NG/NI Tube Retention SystemAvanos Medical, Inc. Oct 25, 2024
K242984 — BKS Revision SystemOrtho Development Corp. Oct 25, 2024
K240269 — Nitrile Powder Free Examination Gloves Biodegradable (Green)Comfort Rubber Gloves Industries Sdn. Bhd. Oct 25, 2024
K240040 — VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd. Oct 25, 2024
K241007 — Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)Shenzhen Urion Technology Co., Ltd. Oct 24, 2024
K242034 — Duet External Drainage and Monitoring System (EDMS)Medtronic Neurosurgery Oct 24, 2024
K242462 — CEREC Cercon 4D CAD/CAM BlocksDentsply Sirona Oct 24, 2024
K242512 — ROCC ConsolePhilips Medical Systems Nederland B.V. Oct 24, 2024
K242458 — ArgenZ MTZArgen Corporation Oct 24, 2024
K241089 — KeyPrint KeyDenture BaseKeystone Industries Oct 24, 2024
K242560 — Manual Wheelchair (SYIV100-CA9221)Foshan Shunkangda Medical Tech Co., Ltd. Oct 24, 2024
K240391 — MUTARS® femoral stem cemented 160 mm and 200 mmImplantcast GmbH Oct 24, 2024
K241554 — Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)Telefield Medical Imaging (Shenzhen) Limited Oct 24, 2024
K242086 — MagDI System (MAG-01, DS-01)Gt Metabolic Solutions, Inc. Oct 24, 2024
K240543 — Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)Medency S.R.L. Oct 24, 2024
K242589 — Scarlet® AL-TSpineart SA Oct 23, 2024
K243057 — TrueFit Bolus; TrueFlex BolusAdaptiiv Medical Technologies, Inc. Oct 23, 2024
K241753 — Immediate Molar ImplantsBiomet 3I, LLC Oct 23, 2024
K241988 — ProSeal™ Closed System Bag AccessEpic Medical Pte. , Ltd. Oct 23, 2024
K234060 — KIDNEYvault Portable Renal Perfusion SystemParagonix Technologies Oct 23, 2024
K242513 — FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K)Guangdong Optomedic Technologies, Inc. Oct 23, 2024
K242829 — BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd. Oct 23, 2024
K243007 — CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. Oct 23, 2024
K242995 — OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company Oct 23, 2024
K240289 — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)Scivita Medical Technology Co., Ltd. Oct 23, 2024
K240865 — IDS-iSYS Free TestosteroneImmunodiagnostic Systems Limited Oct 23, 2024
K242073 — STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KK Oct 23, 2024
K241324 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC Oct 23, 2024
K241876 — Vitesse (5.0)Varian Medical Systems Oct 23, 2024
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 Oct 23, 2024
K243012 — MIM – Symphony HDR FusionMim Software, Inc. Oct 23, 2024
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