FDA 510(k) clearances — page 329
clearances on record, most recent first.
Clearances — page 329
32,801–32,900 of 175,699- K152475 — FORZA PTC Spacer System
- K152869 — LipiView II Ocular Surface Interferometer
- K152966 — Aequalis Fx2
- K152972 — Amendia Stand-Alone Cervical System
- K153025 — Turbett Surgical Container
- K153338 — Tiger Cannulated Screw System
- K153356 — Spine Innovation Interbody System
- K153466 — PillCam COLON 2 Capsule Endoscopy System
- K153591 — ebb Complete Tamponade System
- K153601 — Spectra Optia Apheresis System
- K150019 — TheraVision Ultrasound Ablation System and ACOUSTx Applicators
- K151070 — Sonishield 100 Antimicrobial Ultrasound Gel
- K151312 — VerteLP Interbody Fusion Device
- K151621 — BioHorizons CAD/CAM Abutments
- K151725 — STERRAD NX Sterilizer, STERRAD 100NX Sterilizer
- K152374 — LL TENS 160A, LL TENS 160B
- K152541 — Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
- K152627 — IFS Fixation Scaffold System
- K152684 — Nerve Capping Device
- K152733 — FFRct
- K152854 — S50 Digital Color Doppler Ultrasound System
- K152942 — NuVasiveNVM5 System
- K153125 — IntraNovo Microcatheter
- K153242 — Frontier Medical Devices In-Line Orthopedic Cable Cerclage System
- K153415 — Reprocessed Stryker External Fixation Devices
- K153635 — SALVATION(R) External Fixation System
- K150515 — IQSense Flow Sensor Mouthpiece
- K151152 — ImplantMax Software
- K151282 — core nova Complete Operating Room Endoscopy
- K151450 — Endoscope Sterilization Tray
- K152509 — CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)
- K152589 — Bio2 CLM BG Bioactive Scaffold
- K152696 — INFX-8000V, V6.20
- K152880 — Biograph Horizon PET/CT
- K152993 — MUSE Cardiology Information System
- K153012 — Sofia Influenza A+B FIA
- K153147 — Cios Connect
- K153354 — 3MP Color LCD Monitor, RadiForce RX350
- K150678 — Sysmex Automated Blood Coagulation Analyzer CS-5100
- K151051 — Universa Soft Ureteral Stents and Stent Sets
- K151328 — PURE Ceramic Implants
- K151884 — K-Y Marilyn Pleasure Gel
- K153197 — Fortress Introducer Sheath SYstem
- K143169 — MyGlucoHealth Wireless System
- K150969 — Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
- K151018 — Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
- K151083 — BioBridge Collagen Matrix
- K152245 — ONLINE TDM Vancomycin Gen.3
- K152356 — Sapphire
- K152392 — VINTAGE LD
- K152876 — LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM
- K153039 — MRI Dynamic Analysis Plus
- K153435 — Direct HDL Cholesterol (HDL)
- K143445 — Tellos ISQ Buddy
- K151084 — Well Lead Ureteral Access Sheath
- K151960 — Sterile High-pressure Angiographic Syringes for Single-use
- K152924 — TIVA¿
- K153069 — Edwards Balloon Catheter
- K153214 — Full Automatic (NIBP) Blood Pressure Monitor
- K153217 — ConforMIS iTotal Posterior Stabilized Knee Replacement System
- K153336 — VuePoint OCT System
- K153427 — Volpara Imaging Software
- K153531 — Treace Medical Concepts (TMC) Plating System
- K153541 — Coldplay CryoBalloon® Ablation System
- K151104 — OTELO LL
- K151287 — Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
- K151310 — Amendia Interbody Fusion Devices
- K151662 — iRestore
- K152313 — Medline ReNewal Reprocessed Endopath Endoscopic Instruments
- K152604 — KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
- K152944 — Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems
- K153233 — Galaxy UNYCO System
- K153259 — VasoStat Hemostasis Device
- K153502 — ClariVein IC
- K153536 — Piccolo Composite® Nailing System
- K143004 — VENTURI MiNO TG600/14
- K150459 — FloSure Ventilation Patch
- K151771 — Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
- K152498 — SoloPath Re-Collapsible Access System
- K152536 — MyOn HC Manual Wheelchair
- K152872 — K2M Fenestrated Tap System
- K152954 — Quell
- K153190 — Zenysis Short-Term Dialysis Catheter
- K153265 — New Deantronics Disposable Laparoscopic Electrodes, non-coated, and coated
- K151273 — InMode FRF Applicator
- K151511 — ROSA Spine
- K153037 — LOGIQ V1/ LOGIQ V2
- K153052 — Erchonia PL Touch
- K152746 — Ez3D Plus
- K150585 — Ascent 3D
- K152508 — Ageless Health Medical Digital Thermometer
- K152644 — KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100
- K152809 — Giraffe Incubator Carestation CS1
- K153094 — Visions PV .035 Digital IVUS Catheter
- K153208 — Internal Joint Stabilizer - Elbow
- K151255 — Navigator Aesthetic Delivery System
- K151686 — HumanPen Ergo II
- K151876 — Bio2 Fusion Implant System
- K151907 — Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables
- K152201 — MedActive Oral Gel and Spray
Data sourced from openFDA. This site is unofficial and independent of the FDA.