FDA 510(k) clearances — page 25
clearances on record, most recent first.
Clearances — page 25
2,401–2,500 of 176,479- K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
- K252873 — Q Interbody Instruments
- K253221 — Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
- K253568 — Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
- K253780 — SIGNA Bolt
- K253852 — MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture
- K253927 — LiveMedica Enterprise PACS
- K251517 — Encora X1
- K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
- K253779 — SIGNA Sprint Select
- K253959 — Primevision 3D
- K260028 — CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister
- K250773 — Luna® Ti Interbody Fusion System
- K252301 — Henan Yadu Level 4 Surgical Gowns (Reinforced)
- K252623 — G7® Revision Acetabular System
- K260012 — UltraScore Focused Force PTA Balloon
- K260038 — E3D-C Interbody System
- K260104 — Signature ONE System
- K250644 — MSS - Monobloc stem
- K252048 — 808nm semiconductor laser hair removal machine
- K252087 — Navigation Module of the Cortium® System
- K252438 — Explant Express
- K252676 — The Circadia C300 System (C300)
- K252909 — Diagnostic X-Ray Equipment Model POCT22
- K253282 — ZSmile System
- K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
- K253701 — SmartGuard Technology; Predictive Low Glucose Technology
- K253737 — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
- K251200 — Vital Signs
- K251582 — Redermax Antibacterial Wound Matrix
- K252011 — CHIKAI Nexus petit
- K252286 — BIORES Dental Implant System
- K252649 — TAP2D
- K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
- K250983 — Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)
- K251407 — Motor Handpiece and Control Unit (SDI10)
- K251769 — RevealAI-Lung
- K251981 — Boston PICO (Boston PICO)
- K252457 — Disposable Distal End Tape Hood
- K253318 — Clungene RSV Antigen Rapid Test
- K253671 — Dual Stage Venous Cannulae
- K253833 — Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
- K254283 — BruxZir® Shaded 16 PLUS
- K254290 — ZenTite (4 models)
- K254305 — BAROguard Donor Lung Preservation System
- K243732 — Multi-Unit DAS System
- K251274 — EZ-Protect Hydrophilic Closed System Intermittent Catheter +1 more
- K251354 — UV Smart D60
- K251427 — EK MULTI ANGLED 30 ABUTMENT
- K251923 — Medical Shaver System (Morcellator) (YSB-IIIA)
- K252091 — Surgical Reality Viewer
- K252275 — Electric Scooter (DDF100)
- K252347 — Electric Scooter (Mojo-T580)
- K252349 — Electric Scooter (Mojo-T330)
- K252496 — Neurophet AQUA AD Plus
- K252684 — Labcorp Fentanyl Urine Visual Test
- K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
- K253611 — Falco Fusion System
- K253632 — Manual Wheelchair (W50)
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.