FDA 510(k) clearances — page 337
clearances on record, most recent first.
Clearances — page 337
33,601–33,700 of 176,542- K143713 — Lustre PRO Light System
- K151029 — Phadia Prime
- K151969 — Hospira Extension Sets
- K152215 — DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR
- K152613 — True Flow Valvuloplasty Perfusion Catheter
- K152793 — Unison-C Anterior Cervical Fixation System
- K152980 — Flo Trac sensor, Volume View sensor
- K153333 — Epic Extremity Cannulated Screw System
- K153373 — CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device
- K153618 — Capillus202
- K153664 — M.U.S.T. Pedicle Screw System
- K153669 — MultiFIX S Ultra Knotless Fixation System
- K143153 — EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180V
- K150409 — VIVACE Electrosurgical System
- K151075 — BR-ABVS Viewer 1.0
- K151081 — MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge
- K151228 — PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2: .30mm
- K151269 — ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
- K151320 — BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
- K151491 — Falck Medical Multifunction Tonometer, FAT1
- K151661 — Renovo Life Hard Carbon Coated Drill Bit
- K151794 — da Vinci Xi Surgical System
- K151848 — Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System
- K152134 — Reprocessed Vessel Sealer
- K152450 — Esophageal Cooling Device
- K152522 — ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes
- K152531 — InstaClear Lens Cleaner
- K152620 — Spine Wave Gen II Expandable Interbody System
- K152669 — PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)
- K152690 — DISPOSABLE THERMOMETER PROBE SHEATHS
- K152697 — INFX-8000C, V6.20
- K152777 — Bovie Disposable Bipolar Ablator
- K153289 — HEALTHMYNE
- K153598 — Medtronic Bio-Medicus Adult Cannula Kit
- K153675 — Paragon T2 Wand with Integrated Cable
- K150032 — GluStitch Twist Tissue Adhesive
- K151039 — ATLANTIS Abutment for NobelActive 3.0
- K151141 — Cronus HP - High Pressure Peripheral Balloon Catheter
- K151468 — ARIX Wrist System
- K151487 — Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method
- K151842 — Rainbow Shine
- K151846 — Rainbow LS Pressing
- K152361 — OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension; Injector, OptiOne Base System
- 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¿
Data sourced from openFDA. This site is unofficial and independent of the FDA.