FDA 510(k) clearances — page 29
clearances on record, most recent first.
Clearances — page 29
2,801–2,900 of 176,479- K252235 — PVAD IQ Software
- K252320 — SIMDA Abutments
- K252348 — Tomey Optical Biometer OA-2000 (OA-2000)
- K252402 — Midline Catheter
- K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
- K252793 — ARMI® Endoscopic Video Image Processor (JY-MIP-3000) +1 more
- K252956 — Helo Thrombectomy System
- K252976 — Park Dental Nylon MAD
- K253516 — Assert-IQ (DM5100)
- K253518 — FX CorAL 40; FX CorAL 50
- K253758 — Dental Cone; Dental Sponge
- K253915 — MOVIVA® Hybrid Ablation Probe
- K250854 — Multi-parameter Patient Monitor (6 models)
- K251416 — UltraSight Guidance
- K252191 — BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System
- K252398 — SURFLO Hybria Closed System Safety IV Catheter
- K252417 — Amplatzer Piccolo Delivery System (9-PDS-04F-045)
- K252508 — Intri26 Introducer Sheath
- K252518 — DuoprossTM Smart Cap (Type I)
- K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C) +6 more
- K252922 — Neosoma Brain Mets
- K252983 — Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)
- K253093 — Vital Spinal Fixation System
- K253710 — Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K253719 — Unscented Menstrual Long Applicator Tampon +2 more
- K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K253839 — Elecsys Anti-SARS-CoV-2
- K250925 — ADVIA Centaur Cytokeratin Fragment 21-1
- K251256 — PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
- K251745 — Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
- K251763 — IRISeg
- K251771 — Cambridge Partial Knee
- K251893 — SKAN C PULSAR
- K251951 — Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3) +2 more
- K252111 — Versius Surgical System (Versius Plus)
- K252204 — prolaio eVO2peak Module (Version 1.0)
- K252268 — V series portable oxygen concentrator (V5, V5C, V6, V6C)
- K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology +6 more
- K252468 — Single-use Digital Flexible Ureteroscope (GY-UR9.3) +3 more
- K252919 — IDENTIFY (5.0)
- K252940 — VR® Personal Protective Level 3 Gown (VR Gowns)
- K253118 — Companion Spine DIAM Instrumentation
- K253620 — TroClose 1200
- K250319 — MFUSE (MS001)
- K251302 — OptiMesh Multiplanar Expandable Interbody Fusion System
- K251770 — SleepRes PAP System
- K252574 — Erchonia CLX (Model # CFL)
- K252675 — da Vinci SP Surgical System (SP1098)
- K252898 — Triathlon® Tritanium® Asymmetric Patella +5 more
- K252935 — Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml)
- K252950 — Paradigm System
- K253101 — HyperVue Imaging System - Integrated
- K253403 — FemVue® Controlled Saline-Air Device (FSA-300)
- K253677 — Tembo Embolic System
- K253741 — VStick Vascular Access Set
- K250851 — Hypnos (369054-200)
- K242817 — Jason membrane
- K250488 — Cerynë Intimate Care
- K250821 — Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300) +2 more
- K250847 — VaporShield
- K250863 — FUJIFILM Ultrasonic Endoscope EB-710US
- K250974 — Bio Arterial Deluxe (IC-BAP-DX)
- K251085 — iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro
- K251089 — EXEL Disposable Syringe +3 more
- K251092 — iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
- K251177 — Self-Seal Sterilization Pouch and Roll
- K251989 — VizMark Preloaded Tissue Marker Device (VM-0001)
- K252090 — Pterygoid Indication for GM Helix Implants
- K252120 — Fundus On Phone Non Mydriatic (FOP NM-10)
- K252273 — Therapy US
- K252391 — Revi System
- K252681 — EnCor EnCompass Breast Biopsy and Tissue Removal System
- K252745 — Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
- K252785 — TopCEM Vigor SA Self-Adhesive Resin Cement
- K253489 — Swoop® Portable MR Imaging® System
- K253609 — TRAUMAGEL® 2.0 Hemostatic Gel
- K253749 — Affixus® Natural Nail® Proximal Humeral System
- K250988 — KLS Martin Pure Pectus System
- K251883 — MIM LesionID Pro
- K252482 — CogNet AI-MT+
- K252694 — Target Detachable Coil
- K252897 — APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw) +5 more
- K252941 — HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
- K252997 — HyperFlex® Bunion Correction System
- K253141 — DeepRhythmAI
- K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA)
- K250192 — Verisafe Safety Retractable Insulin Syringes
- K251598 — Intellidrop
- K252497 — SANSA HSAT
- K252826 — ARIX Femur Nail System
- K243449 — INFINITT DPS
- K250742 — Focused Cryotherapy System
- K250805 — DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
- K251199 — Allia Moveo
- K252154 — Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)
- K252343 — Atlantis® Abutments in Titanium
- K252808 — GlasIonomer FX-LC
- K253706 — Lancing device (HH-XV-T)
- K250190 — Sequential Compression System (SCD600)
- K250258 — HeartBeam AIMIGo with 12-L ECG Synthesis Software System
Data sourced from openFDA. This site is unofficial and independent of the FDA.