FDA 510(k) clearances — page 364
clearances on record, most recent first.
Clearances — page 364
36,301–36,400 of 176,542- 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 +1 more
- 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
- K141434 — SATURN 5 LASER
- K141587 — E-Z CLEAR SMOKE EVACUATION ELECTROSURGICAL PENCIL; CLEAR NOZZLE EXTENTION, ULPA FILTER, CHARCOAL FILTER, ADAPTER
- K142774 — Polysmith Sleep System
- K143270 — Optima XR646
- K150246 — Medtronic Model 5392 External Pulse Generator (EPG)
- K140913 — NUROS BONE GRAFT SUBSTITUTE
- K141738 — MEDEOR MATRIX WOUND DRESSING
- K142476 — Master Caution Device MCD
- K142991 — LifeGlobal Global Total w/HSA, LifeGlobal Global Total for Fertilization w/HSA, LifeGlobal Global Total w/HEPES W/HSA
- K143080 — FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
- K143183 — Maxima XTEND Handpiece Maintenance System
- K143337 — CONELOG Titanium base CAD/CAM
- K150105 — Klassic Knee System-Sombrero Patella
- K140881 — DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
- K141205 — LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6
- K141274 — QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.
- K141316 — COGNISION EEG/EP SYSTEM
- K141375 — ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250
- K141946 — DIGITAL ELECTROCARDIOGRAPH
- K142064 — GALILEO NT
- K142156 — SEEGENE ANYPLEX II HSV-1/2 ASSAY
- K142298 — Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
- K142374 — ivWatch Model 400
- K142775 — Neuwater TM (HydrocynTM aqua)
- K142881 — DMRC Dual Cure Orthodontic Band Cement
- K142924 — Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
- K143058 — PuraDerm Gel
- K143127 — CO2-Mas, Oxygen Delivery/ CO2 sampling cannula style, CO2 sampling only style
Data sourced from openFDA. This site is unofficial and independent of the FDA.