FDA 510(k) clearances — page 20
clearances on record, most recent first.
Clearances — page 20
1,901–2,000 of 175,620- K251074 — Tru Liver Health Test Panel
- K251077 — JOULE 1064nm System and Accessories
- K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)
- K251152 — DBLG2
- K251402 — LIA-1 Catheter (542-1)
- K251469 — Endura Ureteral Stent and Stent Set
- K251572 — eRapid with eTrack System
- K251730 — LIA Console (542-7)
- K251751 — Spo2 Sensor CSS032D
- K252029 — AI-CVD
- K252167 — Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
- K252284 — eMurmur Heart AI
- K252342 — Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)
- K252480 — CE Deliver (DLV)
- K252670 — Alzevita
- K252754 — Wearable Electric Breast Pump (YM-8803)
- K252780 — LCD Monitor (CL1902A, CL2103F)
- K252781 — MSFX MIKRON PEEK CAGES
- K252838 — MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise
- K252863 — ClearCalc Model RADCA V2.6
- K252877 — SANDRO Dual
- K252892 — SCOUT MD Surgical Guidance System
- K252974 — EMPOWR Knee
- K253054 — LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)
- K253086 — LED Light Therapy Device (Models: SG-FM, SG-FE)
- K253161 — Balanced Knee System TriMax Porous Femoral Components
- K253202 — Hoffmann LRF System
- K253358 — Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
- K253373 — Southern Craniomaxillofacial (CMF) System
- K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
- K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
- K253577 — IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
- K253613 — Monkey Rings External Ring Fixation System
- K253616 — ProtekDilate Vascular Access Kit
- K253733 — STAR Apollo Mapping System
- K254063 — iCEM Universal Plus
- K250914 — MediAI-BA
- K250993 — Single Use Cytology Brush V (BC-V600P-3010)
- K251562 — OTSCneo System Set (100.03n-14n, 100.27n-31n)
- K251915 — Amethyst HP PTA OTW 0.035 Catheter
- K252071 — RefleXion Medical Radiotherapy System, Reflexion X2
- 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); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)
- 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 (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
- 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); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHICON 4000 45mm Long Stapler (EC3DT45L); ETHICON 3D 45mm White Reload (ER45W); ETHICON 3D 45mm Blue Reload (ER45B); ETHICON 3D 45mm Green Reload (ER45G); ETHICON 3D 45mm Black Reload (ER45T)
- 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; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons
- 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); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)
- 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; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology
- K252468 — Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)
- 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; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper
- 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); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)
Data sourced from openFDA. This site is unofficial and independent of the FDA.