510(k) Clearances — Page 101

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 101 of 3,525)
ClearancesDetails
K250186 — GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA Mar 21, 2025
K241890 — Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbH Mar 21, 2025
K250561 — Natural CyclesNatural Cycles Nordic AB Mar 21, 2025
K241704 — Endoscopic Water PumpHangzhou AGS MedTech Co., Ltd. Mar 20, 2025
K243016 — Starlight Imaging CatheterSpectrawave, Inc. Mar 20, 2025
K243975 — Knee+Pixee Medical Mar 20, 2025
K243922 — RevogeneMeridian Bioscience, Inc. Mar 20, 2025
K250463 — Ameda GLO Wearable Breast Pump (Model W8S)Shenzhen TPH Technology Co., Ltd. Mar 20, 2025
K243292 — brAIn™ Shoulder PositioningAvatar Medical Mar 20, 2025
K242958 — Joylux Intimacy Gel (PG3100)Joylux, Inc. Mar 20, 2025
K243928 — ViaOne Epicardial Access SystemCardiovia , Ltd. Mar 20, 2025
K243988 — RootMend MRRRiverpoint Medical, LLC Mar 20, 2025
K242771 — Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc. Mar 20, 2025
K242770 — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PGDRTECH Corporation Mar 20, 2025
K241884 — HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)Hunan Haipuming Technology Co., Ltd. Mar 20, 2025
K241961 — Vent Creativity Knee v1.0 (Hermes)Vent Creativity Mar 20, 2025
K250468 — iSLEEVE Introducer SetBoston Scientific Mar 20, 2025
K250429 — DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH setMacromedics BV Mar 19, 2025
K250042 — PeekMed webPeek Health, S.A. Mar 19, 2025
K242486 — Tyber Medical Anatomical Plating SystemTyber Medical, LLC Mar 19, 2025
K243472 — 1NEED ProCampomats S.R.L. Mar 19, 2025
K241791 — Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)Gigaalaser Company , Ltd. Mar 19, 2025
K243987 — TriMed Elbow and Forearm SystemTriMed, Inc. Mar 19, 2025
K243999 — TriMed Ankle Fixation SystemTriMed, Inc. Mar 19, 2025
K243092 — AcuPebble Ox (200)Acurable Limited Mar 19, 2025
K242241 — SunnyShenB Co., Ltd. Mar 19, 2025
K243689 — AVIEWCoreline Soft Co., Ltd. Mar 19, 2025
K250502 — SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)Safesource Direct, LLC Mar 19, 2025
DEN240018 — CORIS SystemNanosonics Limited Mar 19, 2025
K241842 — Luer-Split MAJ-2092Olympus Medical Systems Corporation Mar 19, 2025
K250210 — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))Scivita Medical Technology Co., Ltd. Mar 19, 2025
K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NPDRTECH Corporation Mar 19, 2025
K250171 — IPL Hair Removal Device (BE965A, BE965B, BE965C)Shenzhen Yang WO Electronic Co., Ltd. Mar 19, 2025
K250131 — IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)Mustech Electronics Co., Limited Mar 19, 2025
K240933 — CarbonCool® SystemGlobal Healthcare SG Sdn. Bhd Mar 18, 2025
K243807 — Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432POlympus Medical Systems Corp. Mar 18, 2025
K242683 — QP-Prostate® CADQuibim S.L. Mar 18, 2025
K242533 — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl CitrateBetter Care Plastic Technology Co., Ltd. Mar 18, 2025
K241937 — Klarity SGRT System (ARSG-E1A, ARSG-E3A)Klarity Medical & Equipment (GZ) Co., Ltd. Mar 18, 2025
K250494 — The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies Mar 18, 2025
K241729 — Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation Mar 18, 2025
K250413 — Aglaia LED Beauty Device (BP-D2309)Shenzhen Perfect Idea Technology Limited Mar 18, 2025
K240287 — LYHER® Oral fluid Multi-Drug Test Kit (Cube)Hangzhou Laihe Biotech Co., Ltd. Mar 18, 2025
K243556 — Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)Iray Imaging Technology (Haining) Limited Mar 18, 2025
K243553 — QuikClot Control+ Hemostatic DeviceTeleflex Medical Mar 18, 2025
K242161 — Radlink GPS Pro ImagingRadlink, Inc. Mar 18, 2025
K241783 — FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC Mar 18, 2025
K242140 — Air Compression Leg Massager (K-705)Jiale Health Technology Shenzhen Co., Ltd. Mar 17, 2025
K250379 — SIGNA Prime EliteGe Medical Systems, LLC Mar 17, 2025
K243646 — Ziehm Solo FDZiehm Imaging GmbH Mar 17, 2025
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