FDA 510(k) clearances — page 19
clearances on record, most recent first.
Clearances — page 19
1,801–1,900 of 176,428- K260466 — Multifunctional Operational Dissectors (Electrosurgical Pencils) +1 more
- K260860 — Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
- K260942 — AuST Steerable Sheath
- K250208 — SPECTRA Wearable 2
- K252182 — SV70 Ventilator (SV70)
- K252765 — ProSomnus RPMO2 OSA Device (RPMO2 OSA)
- K252809 — in2 Smart (in2S)
- K253025 — Ricoh 3D for Healthcare Bolus
- K253036 — Light-curing Coloring Materials (ALCM)
- K253288 — 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
- K253862 — APERTO Lucent MRI System
- K254084 — AETOS Shoulder System - CONCELOC Glenoids
- K254091 — GLOSSY COAT (15ML)
- K260397 — SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)
- K260459 — VANES Delivery System (VDS)
- K260521 — ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)
- DEN240071 — neuropacs
- K250074 — HYALEX® MTP Hemiarthroplasty Implant
- K252386 — Hot and Cold Compression System (A02-C-032)
- K252495 — LSSA (NP-200)
- K252744 — Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
- K253042 — Tyber Medical Trauma Screw
- K253056 — Disposable Stone Extraction Basket
- K253340 — Electric Wheelchair (AL-208S-063)
- K253674 — Blueprint Patient-Specific Instrumentation
- K253962 — ClearCheck (RADCC V2.7)
- K254060 — Life Saving Tourniquet
- K254066 — Etiometry Platform
- K254153 — Single-use Video Scope; PB Digital Controller
- K260363 — Ceribell Brain Monitor Headband
- K260524 — uMI Panvivo (5 models)
- K260718 — mGRIP Partial Prosthesis (0.75 mm) (58669) +10 more
- K260719 — mGRIP Total Prosthesis (3.00 mm) (58689) +11 more
- K260720 — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717) +9 more
- K260724 — MAGENTIQ-COLO (ME-APDS)
- K260786 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K250516 — SMART M-CELL PRP Concentration System
- K250518 — SMART M-CELL Bone Marrow Concentration System
- K252079 — Disposable Infusion Bag for Parenteral Nutrition
- K252130 — LifeShield Infusion Safety Software Suite
- K252137 — BD Insyte IV Catheter
- K252198 — Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
- K252229 — BELLIGER ACE
- K252246 — Leforte MMF System
- K252709 — Wireless Probe Type Ultrasound Scanner
- K253076 — Cryopush Cold Compression Device (A02-P-001)
- K254022 — FLASH Flex Aorto-Ostial Angioplasty System
- K260026 — Tina-quant Cardiac high sensitivity CRP III
- K260184 — Onclarity Self-Collection Kit
- K260647 — SPECCHIO
- K260796 — Tahoe Unicondylar Knee System with TiNbN Overcoat
- K242303 — MOD-C
- K252513 — Polywin Safety (14G x 51mm +17 more
- K252876 — GEM Flex Coil 16-L Array, 3.0T Receive Only +2 more
- K252943 — GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
- K253405 — Prana System
- K253473 — Synchrony
- K253582 — Medical Imaging Calibration Feature (MICF)
- K253586 — RM Electrode (RMH 25-01)
- K253718 — enHAnce PEEK Bunion System
- K254015 — CoLumbo C-Spine
- K254225 — Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
- K260007 — Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA 10 mg)
- K260276 — Arm Blood Pressure Monitor Models: ARM-30C+ +26 more
- K253029 — RW-1
- K253598 — InjecSURE Injection System
- K260093 — Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
- K260191 — Safety lancet (XXXVII)
- K260319 — K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
- K260375 — Nd: YAG Laser Therapy Systems
- K252158 — Sagami Original 002 Polyurethane Male Condom
- K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
- K252269 — FINDER Flu A&B/SARS-CoV-2 Test
- K253654 — IntelliVue Measurement Rack 6000 (867317)
- K253950 — Avatar Medical Vision
- K254122 — FLOW FLEXTEND Wand (72290039)
- K254207 — AiORTA - Plan v2.0
- K260037 — implantcast Packaging System Update
- K260370 — Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- K260812 — Francisella tularensis Real-time PCR Assay
- K252360 — ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
- K260257 — CO2 Laser System
- K251273 — Asurys Fluid Management System
- K252006 — OTTO Disinfecting Cap
- K252064 — MedCAD® AccuStride System
- K252081 — SportLinc Syndesmosis Device
- K252148 — Butterfly Gestational Age Tool
- K252195 — ARTICOR planner
- K252295 — Ryurei
- K252893 — ExaStim® Stimulation System (EXA-001) +3 more
- K253270 — Contour ProtégéAI+
- K253307 — Electric wheelchair
- K253392 — Synergy Disc Instruments
- K253572 — STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device
- K253595 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
- K253625 — Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
- K253649 — Spectral CT Verida Family
- K253822 — GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
- K253980 — Electrically Powered Wheelchair (Model YC-01)
- K254099 — EVO Q30 Diagnostic Ultrasound System +8 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.