510(k) Clearances — Page 163

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 163 of 3,525)
ClearancesDetails
K234150 — Lucent® XPSpinal Elements Mar 27, 2024
K223360 — LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. Mar 27, 2024
K231425 — Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)Wuxi Jiajian Medical Instrument Co., Ltd. Mar 27, 2024
K222613 — ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc. Mar 27, 2024
K233989 — CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd. Mar 27, 2024
K232891 — CARPL (CARPL)Carpl Ai, Inc. Mar 27, 2024
K233951 — CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc. Mar 27, 2024
K240389 — Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)Hyundae Meditech Co., Ltd. Mar 27, 2024
K240045 — QStat CartridgeHemosonics, LLC Mar 27, 2024
K234097 — Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl CitrateEver Growth (Vietnam) Corporation Limited Mar 27, 2024
K234143 — i-STAT TBI Cartridge with the i-STAT Alinity SystemAbbott Point Of Care Mar 27, 2024
DEN210049 — Medline ART Skin Harvesting SystemMedline Industries, Inc. Mar 27, 2024
K232253 — Modius StressNeurovalens Limited Mar 27, 2024
K233539 — MAMMOMAT B.brilliantSiemens Medical Solutions USA, Inc. Mar 27, 2024
K233201 — MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter)Penumbra, Inc. Mar 27, 2024
K240594 — Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. Mar 26, 2024
K233611 — SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738)Maine Molecular Quality Controls, Inc. Mar 26, 2024
K231793 — RODIN 3D Resin SPLINT, Hard/FlexBelport Company, Inc., Gingi-Pak Mar 26, 2024
K231132 — J & P Click AttachmentsJ & P Dental Technologies Mar 26, 2024
K233151 — PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)Medline Industries, LP Mar 26, 2024
K231984 — Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)Shenzhen Hingmed Medical Instrument Co., Ltd. Mar 26, 2024
K232954 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelBiofire Diagnostics, LLC Mar 26, 2024
K233069 — Removal System Large Bore 60 cc SyringeInari Medical, Inc. Mar 26, 2024
K233650 — SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc. Mar 26, 2024
K233733 — SyMRISyntheticmr AB (Publ.) Mar 26, 2024
K233275 — RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)Gyrus Acmi, Inc. Mar 25, 2024
K240589 — Micropuncture Introducer Sets; Micropuncture Pedal Access SetsCook Medical Mar 25, 2024
K234085 — LUNE™ PureHygieneEnamel Pure Mar 25, 2024
K233167 — LW Implant System – AbutmentOssvis Co., Ltd. Mar 25, 2024
K232268 — STERI-OSS Implant SystemZeros Co., Ltd. Mar 25, 2024
K240620 — Cube NavigatorMedical Templates AG Mar 25, 2024
K233919 — VariAx 2 Distal Radius SystemStryker GmbH Mar 25, 2024
K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)Soterix Medical, Inc. Mar 25, 2024
K240292 — Transcutaneous Electrical Nerve Stimulator (9029SCM)Hong Kong Etech Groups Limited Mar 25, 2024
K240329 — Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)Yongkang Youha Electric Appliance Co., Ltd. Mar 25, 2024
K231986 — Modus IRSynaptive Medical, Inc. Mar 25, 2024
K232282 — aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc. Mar 22, 2024
K240225 — Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL CatheterShockwave Medical, Inc. Mar 22, 2024
K231930 — Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd. Mar 22, 2024
K240690 — STRUXXURE® MCS Anterior Cervical Plate SystemNexxt Spine Mar 22, 2024
K232431 — syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc. Mar 22, 2024
K232920 — RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cmUreteral Stent Company Mar 22, 2024
K232067 — Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use ConnectorMedivators (A Subsidiary Of Steris Corporation) Mar 22, 2024
K231927 — Elecsys PTH , Elecsys PTH STATRoche Diagnostics Mar 22, 2024
K231926 — NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. Mar 22, 2024
DEN230034 — X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) ApplicationScopio Labs , Ltd. Mar 22, 2024
K233262 — Dukal SMS Sterilization WrapDukal, LLC Mar 22, 2024
K233148 — Augment Off-Axis Instrument SystemFix Surgical Mar 22, 2024
K232169 — FITBONE® Transport and Lengthening SystemOrthofix Srl Mar 22, 2024
K233578 — BAHADIR STERILIZATION CONTAINERSBahadir USA, LLC Mar 22, 2024
← Previous Page 163 of 3525 Next →