FDA 510(k) clearances — page 83
clearances on record, most recent first.
Clearances — page 83
8,201–8,300 of 176,479- K240884 — Glide (91000-GL-X)
- K232175 — XN Knee Prosthesis System
- K222766 — Disposable Extension Set
- K232060 — TOSAMA Reusable Applicator
- K232164 — Access NT-proBNP
- K232200 — Disposable Injection Needles
- K232489 — VenusX
- K232587 — MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
- K232608 — Duo Hands-free Breast Pump
- K233034 — Mobility+ Enteral Feeding System OTC
- K233624 — HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx
- K240109 — Medical electronic thermometer (FC01, FC02)
- K240238 — Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR
- K240418 — Stryker Orthopaedics Hip Systems Labeling Update
- K240419 — UltraThineer Zirconia Slurry (5Y-B)
- K240452 — Ceramic Femoral Head
- K240571 — OASIS MRI System
- K240686 — Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
- K240703 — Fine Osteotomy
- K202531 — Azer Scientific Universal Transport Medium
- K221847 — Ni2 Implant System
- K232999 — Lyric4 Hearing Aid
- K233698 — True Enhance DL
- K233757 — TitanPico Laser Workstation (PICO-450)
- K240719 — OC JuggerKnot Soft Anchor
- K240720 — TiLink-P SI Joint Fusion System
- K232409 — Electromagnetic Stimulation Systems
- K232523 — Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%
- K232641 — Neorad Pacs (Neorad Pacs)
- K233313 — Keikku Electronic stethoscope
- K233509 — Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System
- K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
- K233789 — 8Q10 Surclear Smoke Plume Evacuation System
- K234057 — NIRVANA
- K240089 — Face Patches (MT-12MA, MT-12MC)
- K240654 — SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette
- K240744 — uMR 680
- K240760 — CELERITY HP Indicator Tape
- DEN230023 — Rho
- K232147 — CAAS Workstation
- K232599 — TransForm McCarthy Mitral Annuloplasty Ring (TF)
- K232623 — Universal Endometrial Applicator Set (GM11009840)
- K233263 — Disposable Trocars
- K233999 — GalaFLEX LITE Scaffold
- K212878 — Sample preservation solution
- K231728 — BiWaze Clear System
- K240021 — Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K240291 — EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
- K240423 — TDM Anterior Cervical Plate System
- DEN210058 — ELEOSx Limb Salvage System
- DEN220015 — Orthobond Mariner Pedicle Screw System
- DEN230032 — Symani Surgical System
- K223914 — ACTIV Cap
- K232103 — Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
- K232115 — TDM Large Bone Plate and Screw System
- K232792 — icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)
- K232823 — MCG-S (AM1000)
- K232919 — Ambu® aScope Gastro Large; Ambu® aBox 2
- K233192 — Wireless Smart Thermometer
- K233249 — APPRAISE-HRI
- K233666 — CorVista System with PH Add-On
- K233779 — LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
- K233935 — DigiLine Direct Print Aligner System
- K234105 — Catalyst F1x Shoulder System
- K234152 — ACESO Early Pregnancy Test
- K240360 — Wrinkle Treatment Device (JM2)
- K240647 — Virage® Navigation System
- K240737 — G Surgical Marksman MIS System
- K231834 — VSP PEEK Cranial Implant
- K232027 — CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
- K232037 — Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath
- K232114 — TRIBRID® Unicompartmental Knee System
- K232227 — ABLATE-IQ
- K232790 — KONG®-TL VBR System and KONG® C VBR System
- K233026 — Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
- K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
- K233837 — Agile Esophageal Stent System
- K233910 — Vertex Hip Fracture Nailing System
- K240038 — Clear Moves Aligners
- K240071 — Peleton Universal Single Use Power System and Attachments
- K240172 — Preview Shoulder
- K240361 — Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL) +2 more
- K240639 — PINNACLETM Constrained Acetabular Liners
- K240652 — Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
- K230889 — Digital Thermometer
- K232653 — Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
- K232899 — AI-Rad Companion Organs RT
- K233548 — Uresta®
- K233618 — Oxevision Sleep Device
- K240135 — Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000)
- K240282 — IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)
- K240350 — AnyPlus II Spinal Fixation System
- K240618 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens +3 more
- DEN230036 — Sepsis ImmunoScore
- K211815 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
- K232112 — R&G Surgical Mask
- K232835 — Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
- K233750 — ECG-less Cardiac
- K233975 — Zoom 6F Insert Catheters
- K240080 — Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Data sourced from openFDA. This site is unofficial and independent of the FDA.