FDA 510(k) clearances — page 107
clearances on record, most recent first.
Clearances — page 107
10,601–10,700 of 175,620- K223552 — Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial
- K230023 — ART-Plan
- K230053 — SimpliFix Hip System
- K230090 — Diode Laser Hair Removal
- K230766 — Altus Spine Monaco Pedicle Screw System
- K213170 — SENSOSEEG Depth Electrodes
- K221895 — Terumo Advanced Perfusion System 1
- K223513 — UniVy OsteoVy-Ti Cervical IBF System
- K223784 — Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200
- K230494 — ClotTriever BOLD Catheter
- K230698 — Anivia SG1000 Pump Console
- K230764 — OsteoCentric Integrated Hip Fastener System
- K230820 — SofWave System
- DEN220059 — NTX100 Tonic Motor Activation (NTX100 ToMAc) System
- K222469 — TIB Abutments
- K222829 — Curian® Shiga Toxin
- K223454 — Custom-made Invisible Aligners
- K223564 — X-CUBE 50, X-CUBE 60
- K223577 — Localite TMS Navigator TS
- K230429 — Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device
- K230544 — SnugFit All-Suture Anchor extension
- K230749 — TriMed Threaded Intramedullary Nail System
- K230772 — Quantib Prostate
- K213676 — Masimo Rad-G with Temperature
- K221974 — EpiFinder
- K220345 — STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
- K220854 — TrachCuff Cuff Controller
- K221865 — BTL-094
- K222066 — LINK MobileLink Acetabular Cup System
- K223018 — OSPREY PERIPHERAL IV Catheter System
- K223509 — Compremium Compartment Compressibility Monitoring System (CPM#1)
- K223566 — ELITA Femtosecond Laser System, ELITA Patient Interface
- K223705 — EndoflipTM 300
- K223785 — N9+
- K230411 — Dragonfly OpStar Imaging Catheter
- K230685 — AutoContour Model RADAC V3
- K193514 — AUTION MAX AX-4060 Urinalysis System
- K213986 — CerebralGo Plus
- K220763 — ALPCO Calprotectin Immunoturbidimetric Assay
- K222185 — Stratus Infusion Catheter
- K222200 — CIRRUS HD-OCT
- K222350 — Sterile Nitrile Surgical Gloves Powder Free
- K222738 — Point implant system
- K223435 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- K223879 — Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
- K230010 — ADSEAL Plus
- K230098 — Trusana
- K230143 — DESS Dental Smart Solutions
- K230264 — Ezra Flash
- K230387 — ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S)
- K230393 — UniCam Evo Software
- K230412 — Symmed Elite Aesthetic
- K230694 — NaviCam Xpress Stomach System, NaviCam Xpress System
- K230719 — BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
- K230868 — SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
- K220312 — Polyfusion IV Administration Sets
- K223332 — Task Force CORE
- K223838 — Catalys Precision Laser System
- K230424 — Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System
- K221303 — Neuspera Nuity System
- K222781 — Augmento
- K222910 — Bronchoscope System
- K223530 — Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
- K223763 — ZeptoLink IOL Positioning System
- K223830 — Ultrasound System 2300
- K230402 — ENROUTE® Transcarotid Neuroprotection System
- K230705 — POT PTCA Balloon Dilatation Catheter
- K230732 — Eagle S/Saevo Slim/D700 Slim
- K230753 — RCT800
- K230754 — L12 LED Light Source with AIM
- DEN220033 — MISHA Knee System
- K222887 — Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
- K223176 — Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister
- K223550 — DMX
- K230122 — IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
- K230164 — TENS and EMS Stimulation (OTC)
- K230360 — IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
- K230366 — Arthrex Univers Revers Monoblock Stem Size 4/33
- K230695 — APRO 70 Catheter and Alembic Aspiration Tubing
- K230699 — ARIA Radiation Therapy Management (v18.0)
- DEN210055 — The N-SWEAT Patch
- K220456 — Elecsys FT4 IV
- K222909 — Axiostat Gauze
- K223052 — Peri-Guard and Supple Peri-Guard
- K223088 — BD SmartSite Needle-Free Connector
- K223373 — Enivo
- K223640 — Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axoguard HA+ Nerve Protector (AGHA36); Axoguard HA+ Nerve Protector (AGHA48)
- K223772 — PRO Plating System, Stryker Trauma Pelvic Set (Matta)
- K223816 — Dental CT Scanner AXR
- K230064 — Mazor X System (Mazor X Stealth Edition)
- K230318 — Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring
- K230575 — Limbus Contour
- K230658 — SKOUT® system
- K222023 — RayFlow
- K222197 — F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
- K222360 — AI-Rad Companion (Cardiovascular)
- K222739 — Disposable Insulin Pen Needle
- K223458 — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
- K223531 — CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
- K223774 — Contour ProtégéAI
Data sourced from openFDA. This site is unofficial and independent of the FDA.