FDA 510(k) clearances — page 17
clearances on record, most recent first.
Clearances — page 17
1,601–1,700 of 175,620- K253763 — Y-Knotless Flex Anchors
- K251043 — Mpact 3D Metal Implants Extension DMLS Technology
- K251306 — Seg Pro V3 (RT-300)
- K251347 — Sterilization Pouch/Roll
- K251622 — Hand Massager (SM004D)
- K251896 — XeliteMed SuperM-Fix Spinal Bone Cement
- K252015 — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
- K252164 — NorthStar Mapping System
- K252603 — HIGHERDOSE Body Sculptor (Model: GS-03)
- K252834 — Sacroiliac Joint Truss System (SJTS)
- K253224 — MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
- K253254 — GBT Machine Airflow Prophylaxis Master
- K253388 — Sleepiz One+ (Model 2.5)
- K253842 — Vena MicroAngioscope System
- K260004 — Aevumed PROTEKT Suture Anchor
- K251195 — BriefCase-Triage
- K251435 — InbellaIgnite RF System
- K251995 — Access anti-HAV IgM
- K254220 — Reusable 3 Button Fingerswitch Wand
- K254221 — Optima Coil System (OptiOne Coil System)
- K251670 — MAC 7 Resting ECG Analysis System
- K253412 — Tablo Hemodialysis System (PN-0008000, PN-0006000U)
- K253499 — Ascent3T Neonatal Magnetic Resonance Imaging System
- K252753 — Vydence Family of Lasers
- K253633 — Holmium Laser Therapeutic Apparatus (HZ-40)
- K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0)
- K250741 — Evidence MultiSTAT DOA Urine MultiPlex
- K251351 — AccuContour 4.0
- K252568 — New Day Skin Spray
- K252755 — POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
- K252957 — Pneumo Dissector Hook
- K253160 — Syntex Exam Gloves
- K253285 — Elitone for Men
- K253669 — TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)
- K253712 — LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)
- K253738 — 3.0T AIR 32CH HNA
- K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System
- K253761 — HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)
- K251323 — Device 104 Particulate
- K251511 — PhenoMATRIX
- K252307 — Getinge GSS67N Series Steam Sterilizer
- K252352 — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System
- K252885 — OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
- K252984 — Perin Health System (PHD80060-2)
- K253057 — AI-Rad Companion Brain MR
- K253253 — IPDmilled Blanks
- K253315 — Straumann Variobase Abutments XC for Bridge/Bar
- K253498 — Pump In Style® Pro+
- K253652 — Genie MAX Large Bore Introducer Sheath
- K253735 — AV Vascular
- K251281 — Nova Max Creat eGFR Monitoring System
- K251286 — Affirm 400
- K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)
- K252369 — Boston Pico755
- K252977 — Halcyon, Ethos Radiotherapy System (5.0)
- K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System
- K253730 — RoVo Mechanical Thrombectomy System
- K254165 — Infinity OCT System
- K260170 — LumiCera
- K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
- K251318 — VariFuse Adjustable Infusion Catheter
- K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)
- K252537 — Rusch SoftSimplastic Foley Catheters
- K253173 — uCT 780 with uWS-CT-Dual Energy Analysis
- K253291 — Excelsior System
- K253597 — Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System
- K253698 — Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes
- K253998 — Clearview Intracoronary Shunts
- K254085 — CARTO 3 EP Navigation System V9.0 with PIU Plus
- K254114 — Baylis Connector Cable
- K251970 — Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
- K253363 — NeuroSpan Bridge
- DEN250005 — Sana Device
- K250135 — WAVE Clinical Platform (2.0.000)
- K251249 — Tru Hematology Test
- K251341 — VITAL Tubing Sets for Hemodialysis
- K251353 — Eyer 2
- K251367 — OptoMonitor 3
- K251448 — FL-10000U Respiratory Humidifier
- K251714 — Ion-C
- K251721 — Xpert GI Panel
- K251739 — da Vinci Surgical System (IS5000)
- K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter
- K251790 — SeptAlign
- K251900 — MY01 Continuous Compartmental Pressure Monitor
- K251934 — qXR-Detect
- K252205 — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System
- K252297 — Toro 88 Superbore Catheter
- K252634 — Imagine® Enterprise Suite
- K252767 — actiTENS mini
- K252775 — NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, Egg
- K252960 — SOLIUS PRO UVB Light Panel
- K253082 — LZI Buprenorphine II Enzyme Immunoassay
- K253408 — CoolTone
- K253556 — da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator
- K254126 — Natrelle 133S Tissue Expanders
- K254186 — Azurion R3.1
- DEN250009 — VitaSmart Hypothermic Oxygenated Perfusion System
- K251254 — Ignite RF System
- K251308 — SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
Data sourced from openFDA. This site is unofficial and independent of the FDA.