FDA 510(k) clearances — page 22
clearances on record, most recent first.
Clearances — page 22
2,101–2,200 of 175,620- K252786 — Led Light Phototherapy Bed (Pro 450/ GY-680A)
- K252827 — IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)
- K253250 — Minuteman® G6 MIS Fusion Plate
- K250636 — Sophy Mini Monopressure Valve (SM1)
- K252217 — CT VScore+
- K252658 — Medical Diode Laser Systems (TR-B)
- K253303 — Dendrite Imaging System
- K252760 — Carriere® Motion Pro® Clear Bite Corrector
- DEN240077 — MuReva OM
- K242976 — Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
- K251058 — Tru Kidney Health Test Panel; Tru Analyzer
- K251674 — Fenom Flo FeNO Monitoring System
- K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
- K252000 — uDR Arria & uDR Aris
- K252248 — CEREC Tessera Abutment System
- K252260 — RELIEEV HSG Catheter (HSG7FA1)
- K252355 — K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing
- K252388 — Vanquish Water Vapor Ablation Device
- K252405 — Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter
- K253168 — 0.014 Willow Guidewire
- K253269 — OEC One CFD
- K250635 — FEops HEARTguide Simulation Application
- K250694 — Scaida BrainCT-ICH (v1.0)
- K251070 — Akura Thrombectomy System
- K251401 — PennPET Explorer Positron Emission Tomograph
- K251550 — NX01 (NX01)
- K251798 — RCT700
- K251932 — Spectra Platinum
- K252004 — enCore Night Guard
- K252161 — Hushd Avera
- K252253 — Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®
- K252289 — Eva Scalp Cooling System
- K252555 — Medusa Orthopedics Boa External Fixation System
- K252610 — ZSFab Lumbar Interbody System
- K252762 — HALO AP Dx
- K252889 — Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
- K253219 — LeafPure-Echo (LM-LPNdA)
- K253304 — IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)
- K253310 — 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
- K253344 — BELLUS-Q
- K253365 — LuxCreo Flexible Partial Denture Resin
- 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 (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)
- 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 (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)
- 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 (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)
- 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); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)
- K252625 — The Response Ortho Smart Fixator - Hexapod System
- K252846 — TaperSet Hip System
- K253007 — Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)
- 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); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun
- 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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.