FDA 510(k) clearances — page 31
clearances on record, most recent first.
Clearances — page 31
3,001–3,100 of 176,479- K242503 — Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
- K250634 — BCM2-Body Composition Monitor
- K250769 — Dakota LP System
- K251631 — The BAG manual resuscitator and accessories
- K252328 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K252366 — a2z-Unified-Triage
- K252509 — AlphaVac Multipurpose Mechanical Aspiration System F1885
- K252688 — Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
- K252704 — F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St)
- K252771 — Holmium Laser System (5 models)
- K252787 — Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)
- K253407 — NeVa PV Thrombectomy Device
- K250927 — KARL STORZ Cholangiography Set
- K250560 — BEE HA
- K250586 — Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
- K250700 — Pen Injector Needle 32.5
- K250714 — FluoroDose Varnish
- K251205 — Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants
- K251293 — CardioVision
- K251506 — Nelli (Version 7.11)
- K251607 — Oxygen Concentrator (J5A)
- K251849 — StaClear Syringe (3 models)
- K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
- K251880 — Archy Dental Imaging
- K252070 — Ceribell Infant Seizure Detection Software
- K252590 — Powered Mobility Scooter (PMS105, GUT177, GCAT047)
- K252666 — Articulator Arthroscopic Bur
- K252686 — EffortMed PEEK Cages & Corpectomy Cages
- K252687 — Manual Wheelchair (HM305-Air1, HM305-Air2)
- K252696 — LEGACY
- K253681 — TERA HARZ Hard Denture (8 models)
- K242606 — Nuvis® Wireless HD Camera System (Nuvis-2K)
- K243753 — cobas liat Bordetella panel nucleic acid test
- K250643 — Disposable Polymer Ligation Clips
- K250963 — PlanOne 1
- K251365 — OptumSI Implant System
- K251822 — MAGNETOM Free.Max; MAGNETOM Free.Star
- K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01) +1 more
- K252625 — The Response Ortho Smart Fixator - Hexapod System
- K252846 — TaperSet Hip System
- K253007 — Laser Fiber (6 models)
- K253070 — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
- K253105 — HardyDisk AST Cefiderocol 30µg (FDC30)
- K253123 — CuRAS hybrid
- K253190 — CORUS-LX Implant
- K253324 — UltraPrint-Dental Denture UV
- K253495 — syngo.MR Applications (VB80)
- K242603 — MyPAO SA guides
- K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
- K250651 — OptiPAP Junior Flexi Tube US (OPTIPAPFUS) +10 more
- K250912 — IntelliSep Test
- K251910 — Focal One®
- K252642 — Microcurrent Facial Device (CEC101, EEI101)
- K252661 — SternaFuse Ti Fixation System
- K252884 — Guided Aarhus Applicator Set
- K253035 — IPL Hair Removal Device (SYL001AZ, SYL002AZ)
- K253073 — LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)
- K253197 — ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
- K243981 — Hexoskin Medical System (7100-00016)
- K251191 — Collagen Dura Regeneration Membrane - Repair
- K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (5 models)
- K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (3 models)
- K252281 — ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
- K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom
- K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
- K252582 — Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems
- K252636 — Fluido Compact System
- K252729 — Universal Spinal System
- K252818 — Dexcom Smart Basal
- K253411 — Miniature Telescope for Urology (27033AA)
- K253423 — ToeJack MIS Bunion System
- K250588 — Access Rubella IgG
- K251141 — Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more
- K251566 — TS-RF Generator (STS10)
- K252086 — DTX Studio Assist
- K252330 — DeepRESP
- K252792 — PM2 System with ECGuide Connector
- K253487 — ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultrasound System
- DEN250015 — Neurolyser XR (NXR100)
- K250471 — AquaC UNO H
- K250501 — System Sophi
- K250525 — Second Opinion® Panoramic
- K250865 — KLS Martin IPS Forearm System
- K251078 — AutoDensity
- K251538 — Status COVID-19/Flu A&B
- K251659 — Mesh Nebulizer (H6)
- K251756 — Sterilization Trays
- K251821 — ARC-EX System
- K251872 — Biomoneta Avata Rx
- K252618 — IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)
- K252627 — Lyme-ID IgG Test; Bio-ID800
- K251314 — Rosa® Knee System
- K251662 — Air Compression Therapy Device (4 models)
- K251842 — Dental Computed Tomography X-ray System
- K252308 — LED Beauty Mask (RLBXX)
- K252592 — TELLTALE Electrosurgical Guidewire System
- K252949 — Geminus Volar Distal Radius Plating System
- K253457 — ACUSON Juniper Diagnostic Ultrasound System; ACUSON Juniper Select Diagnostic Ultrasound System
- K243715 — Synthes Patient Specific Implants
- K243897 — PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
Data sourced from openFDA. This site is unofficial and independent of the FDA.