FDA 510(k) clearances — page 356
clearances on record, most recent first.
Clearances — page 356
35,501–35,600 of 175,770- K150085 — GE EchoPAC
- K140990 — EMS PIEZON 707 BIK AND PIEZON 707 BIK LED
- K141123 — ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM
- K141183 — EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES
- K141468 — BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)
- K141559 — V-GUIDE FOR VENTRICULOSTOMIES
- K141922 — IRIS INTELLIGENT RETINAL IMAGING SYSTEM
- K142119 — PROCOTYL L-O ACETABULAR SYSTEM
- K142172 — LIGHTMED TRUSCAN 577
- K142731 — HEARTWAY Electrically Powered Wheelchairs
- K143303 — Single Use Biliary Balloon Dilator
- K143314 — Progressive Orthopaedic Total Hip System
- K143439 — KATANA Zirconia
- K143576 — Exactech Ambassador
- K150201 — Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
- K142178 — PROROOT MTA WHITE, PROROOT MTA GRAY
- K142498 — MAGNIFY and MAGNIFY-S Spacers
- K142576 — Spinal System
- K142623 — PANAVIA SA Cement Plus Handmix
- K142985 — UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
- K143228 — Ancora LLC Interbody Fusion Device
- K143323 — OS2-V Varisation Staple
- K143373 — IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
- K143415 — Air Bubble Based Infuser (ABBI)
- K143652 — Vector PTA Balloon Dilatation Catheter
- K150162 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
- K150174 — EMMA
- K150190 — IntraTemp Solution Warmer
- K150233 — NIOX VERO Airway Inflammation Monitor
- K141506 — MCC Para-Fix CARY BLAIR MEDIUM
- K142823 — Biomet Microfixation Thoracic Fixation System
- K143015 — Hospira Primary Sets
- K143088 — GastriSail Gastric Positioning System
- K143230 — Palladian Lumbar Pedicle Screw System
- K143350 — Nile Alternative Fixation
- K143417 — ANAX 5.5 Spinal System
- K143636 — IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material
- K150009 — Baide
- K150020 — Irritrol, EDS Combo-Rinse
- K150179 — CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
- K150200 — CD HORIZON Growth Rod Conversion Set
- K141504 — T-8000 THEROZONE UNIT
- K141657 — THD REVOLUTION
- K141694 — AESCULAP ORTHOPILOT NEXT GENERATION
- K142296 — Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, Disposable Inner Cannula
- K142479 — MEGNA BREAST PUMPS
- K142848 — EAZY PRIMER
- K142937 — Endoscope Sterilization Tray
- K142956 — NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit
- K143123 — Synergetics PHOTON EX
- K143319 — Syngo X-workplace SW VD10
- K150336 — Photonica Professional
- K141429 — SORRENTO BONE GRAFT SUBSTITUTE
- K142128 — KANGAROO ENTERAL FEEDING SYRINGES WITH ENFIT CONNECTOR
- K143105 — Picosure Workstation
- K143214 — SCARLET® AC-T Secured Anterior Cervical Cage
- K143260 — Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider
- K143382 — DentiAnn Smart Sil
- K143395 — Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
- K150121 — Zimmer Periarticular Plating System
- K150166 — Extremity Medical Suture Anchor
- K141246 — LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM
- K142345 — Talos-C(HA) Cervical Intervertebral Body Fusion Devices
- K132220 — PJ'S SERENITY
- K132868 — CARRICELL
- K133019 — FIBERION OPHTHALMIC ENDOLASER PROBE
- K141401 — EASY OUT
- K142167 — MEDENTIKA ABUTMENT SYSTEM
- K142205 — NuVasive X-CORE(R) Expandable VBR System
- K142248 — Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope
- K142432 — StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit
- K142435 — 3S Safety Syringe with/without Needle
- K142511 — U50 Diagnostic Ultrasound System
- K142693 — ZywieAI Software Library
- K142888 — Fingertip Pulse Oximeter
- K143122 — Volcano iFR Harvest Software (Offline)
- K143135 — Spring Coil Guidewire
- K143191 — IntelliSense Drill
- K143431 — Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
- K143635 — KINETIS Total Knee System
- K143705 — NeedleCam HD Visualization System
- K150024 — Bissinger Monopolar Cables
- K150148 — Terason uSmart3300 Ultrasound System
- DEN140044 — 23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
- K141285 — BUSSE EXTENSION SET
- K141410 — ORAGENE DX OGD-500.001
- K141798 — SYPHER SPACER SYSTEM
- K142358 — Osstell IDx
- K142436 — 3S Safety Insulin Syringe
- K142597 — Vienna System
- K142996 — StaXx(R) XD System
- K143005 — FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0
- K143049 — LYNC intramedullary implant
- K143111 — Codman Certas Plus Programmable Valve; Codman Certas Toll Kit
- K143381 — Sensititre Susceptibility Plates
- K143457 — NeuroBlate System
- K150005 — Checkpoint, Checkpoint Head & Neck
- K150097 — GM60A-32S & GM60A-40S
- K150147 — Lubrigyn cream
- K140045 — BODY COMPOSITION ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.