FDA 510(k) clearances — page 115
clearances on record, most recent first.
Clearances — page 115
11,401–11,500 of 176,479- K230553 — LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
- K230829 — TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
- K220513 — NITRO Interbody Fusion Cage System Family
- K222676 — Ceevra Reveal 3
- K223139 — Wallaby 017 Micro Catheter
- K230056 — MiVu Esophageal Endo Cap
- K230202 — TMINI Miniature Robotic System
- K230204 — ALPHALOK Plating System
- K230218 — DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
- K230223 — iCAC Device
- K230503 — Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable
- K230549 — IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG
- K230594 — Tigereye ST CTO-Crossing Catheter
- K230906 — Konicaminolta DI-X1
- K220261 — NEST-C Interbody System
- K220274 — Kisar Stratford SI Screw System
- K222330 — The Heart Seat
- K222690 — SmartGUIDE deflectable hydrophilic guidewire
- K223141 — STR8 Clear Aligner
- K223372 — Omnipod GO Insulin Delivery Device
- K230103 — Klockner Abutments
- K230136 — TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
- K230140 — TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)
- K230704 — RAIN Sheath Tibial Pedal Introducer
- K221142 — Kyphoplasty Balloon System
- K221742 — CONNEQT PULSE
- K222210 — AEON Endoscopic Stapler
- K222291 — Paradigm System
- K222604 — dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
- K223069 — Modular Rotating Hinge Knee Systems and Compatible Components
- K223300 — Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument
- K223501 — ViewFinder Software Version 1.1
- K230084 — HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System
- K230468 — EzDent Web
- K230783 — Anatase Spine Surgery Navigation System
- K230789 — Knee+
- K230808 — PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
- K230811 — Digital Intraoral X-Ray Sensor
- K230816 — Intense Pulsed Light Treatment System
- K230819 — OmniGuide RFID Surgical Laser Fibers
- DEN220082 — Breast Implant Removal Device (BIRD)
- K211153 — Inomax DSIR
- K212220 — ArtFX Spinal Fixation System
- K220981 — SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
- K222095 — BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
- K222261 — Flexible Video-Choledochoscope System
- K223238 — STARband 3D
- K223287 — Velacur
- K223662 — Neodent Implant System - Helix Short Surgical Kit Cases
- K223768 — RadiForce RX270
- K230565 — HILINE Fixation System
- K230785 — Precision1, Precision1 for Astigmatism
- K230807 — Deep Learning Image Reconstruction
- K211748 — Selux AST System; Model AST Gen 1.0
- K220288 — NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector
- K221042 — Renova RP Centesis Pump
- K221220 — Montross Extremity Medical Hemi Implant System
- K223168 — Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface
- K223201 — TAP Lancet
- 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 +1 more
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.