FDA 510(k) clearances — page 19
clearances on record, most recent first.
Clearances — page 19
1,801–1,900 of 175,620- K253793 — Materialise TKA Guide System
- K251630 — Atellica IM Total PSA II (tPSAII)
- K251668 — SurfRider 13 Microcatheter
- K251757 — Puracyn® Plus Antimicrobial Irrigation Solution
- K252018 — HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
- K252650 — Disposable Medical Face Mask
- K252988 — ChartCheck (RADCH V1.6)
- K253008 — maiLink
- K251178 — Ready to use Nelaton Catheter
- K252817 — Mobility Scooter (BC-MS310)
- K253854 — MONTAGE XT Cranial Cement
- K253867 — FiberLocker Implant ; FiberLocker Instrument ; FiberLocker PowerUnit
- K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
- K252901 — Tyber Medical Trauma Screw
- K252951 — Genesis Sleep
- K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
- K253888 — MOLLI 2 System
- K242492 — Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)
- K250168 — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer
- K251091 — Lipids
- K253532 — TruSPECT Processing Station
- K253844 — AnyScan 3.0 NM Scanner Family
- K253895 — Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
- K251025 — Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)
- K251123 — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
- K251313 — Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT
- K251534 — Oxygen Concentrator (J10A)
- K253325 — ZipToe Hammertoe Fusion System
- K253343 — Celebrace Software
- K253881 — Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)
- K253279 — Feather/numiere 05 06 07 (05)
- K253342 — PICO-K
- K253349 — Hair Regrowth Cap (Model: T-119-HRC)
- K253400 — LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)
- DEN250004 — QIKCAP System
- DEN250032 — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
- K250476 — NizPlant Dental Implant System
- K251268 — Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
- K251683 — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)
- K251800 — Healgen® URS Test Strips
- K251958 — VEINOPLUS Back
- K251978 — LIAISON NES FLU A/B, RSV & COVID-19
- K251991 — SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)
- K252145 — GEN5 and GEN5+ 3.3mmD Dental Implants
- K252146 — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
- K252187 — Aura Glide (FC40)
- K252379 — AIR Recon DL
- K252493 — NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)
- K252633 — UNITY DX (UDX)
- K252835 — Electric Scooter (S202572J, S2060, M2089, S2050)
- K253072 — Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D)
- K253091 — ART-Plan+ (v3.1.0)
- K253122 — Sim&Size
- K253135 — LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)
- K253217 — MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
- K253239 — Active-V Total Knee System; World Total Knee System
- K253281 — UpDoc
- K253312 — OrangeCAD Med Abutments
- K253341 — Custom Abutments AS
- K253567 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
- K253675 — OsteoRemedies Hip Spacer System
- K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D)
- K253754 — Philips Lumea IPL
- K254163 — VarioSurg 4
- K243342 — KP Protective Face Mask
- K250756 — Pression Wave PRO External Counter-Pulsation System
- K250959 — BioticsAI
- K251019 — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
- K251105 — Tetra (TM-20); Tetra (TM-50)
- K251159 — Power wheelchair
- K251605 — DIMPLO Implant System
- K251764 — Oxygen Concentrator-P2-O5E
- K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs
- K252068 — MC2 Portable X-ray System
- K252109 — RayStation (2024A SP3)
- K252361 — AccurECG Analysis System (v2.0)
- K252557 — Lumify Diagnostic Ultrasound System
- K252611 — aprevo® cervical plating system
- K252616 — Portable oxygen concentrator (JLO-190P)
- K252673 — LacertaMatrix
- K252743 — STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device
- K252856 — PeekMed web
- K252981 — EmbraceMini
- K253222 — Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
- K253339 — Theracor
- K253661 — TMINI Miniature Robotic System
- K253664 — SKOUT system
- K253727 — Syndesmosis TightRope PRO
- K253769 — Instylla Delivery Kit
- K253781 — InnoClip Clip Applier
- K253876 — HEDRON Cervical Spacers (HEDRON C-MIS Spacer)
- K253903 — InnoClip Disposable Clip Applier
- K232365 — Vivo 45 LS
- K250314 — Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
- K250864 — MatriDerm pluS+ Bi-Layer
- K250976 — Airbile-100
- K250998 — CO2 Laser Therapy System (Model: LFS-D9U)
- K251011 — Chiavaye Personal Moisturizer
- K251037 — Rectal Applicator
- K251050 — Pectus Versa System
Data sourced from openFDA. This site is unofficial and independent of the FDA.