FDA 510(k) clearances — page 362
clearances on record, most recent first.
Clearances — page 362
36,101–36,200 of 176,542- K141278 — MAGEC SPINAL BRACING AND DISTRACTION SYSTEM
- K142448 — VARIANT II TURBO HbA1c Kit - 2.0
- K142649 — Progressive Orthopedic Total Knee System
- K143095 — MiniStim MS-IVB Peripheral Nerve Stimulator
- K143096 — SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA
- K143287 — Fluidshield* Surgical Mask with Expanded Chamber
- K150193 — Customer Remote Console (CRC)
- K150368 — Tarsa-Link Wedge Fixation System
- K140477 — BIOGEL PS SURGICAL GLOVE SERIES, BIOGEL SKINSENSE SURGICAL GLOVE SERIES
- K140806 — IBS IMPLANT SYSTEM
- K140954 — LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING
- K141938 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET (DISPOSABLE BLOOD TUBING SET)
- K142236 — BioniCare Hand System
- K142402 — BigEasy Non-Rebreathing Valve
- K142776 — Flow-Screw
- K143173 — Stryker CMF MEDPOR Customized Implant
- K143207 — Revitive IX (OTC)
- K150099 — Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)
- K150469 — Integra Laminoplasty System
- DEN130047 — PROLONG
- K140356 — SUMMED HIGH PRESSURE LINE
- K141460 — FINAPRES NOVA NONINVASIVE HEMODYNAMIC MONITOR
- K141493 — PROXIMAL HUMERUS PLATING SYSTEM
- K142174 — BIOMATE DENTAL IMPLANT SYSTEM
- K142332 — BT-400
- K142344 — DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System
- K142531 — F1-Modular Pedicle Screw System
- K142545 — SonoFlow Sonohysterography and Sonohysterosalpingography Device
- K142561 — LM-9300 ELMA Lithotripter
- K142711 — ONFLEX Mesh
- K142769 — Fetal Doppler
- K142778 — ARROW Reverse Shoulder long keel and short keel glenoid base
- K142959 — Vyntus Walk
- K143010 — LENSAR Laser System - fs 3D
- K143128 — mDIXON XD
- K143158 — Xenco Medical Lumbar Interbody System
- K143211 — myVision Track Model 005
- K143279 — LnK Anterior Cervical Plate System
- K143313 — NxStage Therapeutic Plasma Exchange (TPE) Cartridge
- K143404 — SurgiQuest AirSeal iFS System
- K143626 — inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System
- K143668 — Navio
- K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM
- K150422 — EOPA 3D Arterial Cannula
- K150441 — Volcano iFR Modality, iFR Scout feature
- K150449 — LITe Plate System
- K141042 — MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
- K142337 — Blackford Analysis Registration Product Family
- K143463 — IS4/DF4 Port Plug
- K143503 — BioMonitor
- K143546 — Imbibe Aspirating XIA Taps
- K143717 — Treace Medical Concepts(TMC) Plating System
- K150003 — Aquilion LB, TSX-201A/3, V6.0
- K150448 — NMI PICC III and NMI PICC IV
- K133788 — COOK HOLMIUM LASER FIBER
- K142001 — SYNTEC WETALI ORTHODONTIC MINI SCREWS
- K142886 — DMRC Self-Cure Bracket Adhesive One Step and Primer
- K142992 — TULIP Natural Rubber Latex Surgeon's Glove (Powdered)
- K143218 — Penumbra Smart Coil
- K143580 — PeriCoach
- K143601 — U-Lite
- K143651 — Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack
- K143703 — NICAL SMART MICRO CR system for intraoral dental images
- K143184 — Evolve UniPolar Head
- K143216 — Assurance Alar / Nasal SpO2 Sensor
- K143329 — AmpliVue Trichomonas Assay
- K143663 — MiroCam Capsule Endoscope System
- K141164 — ARTEMIS LIGHT ENGINE
- K141455 — EASYDRILL AUTOSTOP CRANIAL PERFORATOR
- K141595 — O-TWO E700,O-TWO E600,O-TWO E500
- K141929 — ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
- K142988 — Sleepware G3
- K150030 — Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
- K150180 — InTone
- K150225 — NovaGold High Performance Guidewire
- K150390 — Nautilus Spinal System
- K141237 — HARMONY LITE
- K141665 — NuVasive CoRoent System
- K141944 — HOME ACCESS AIC TEST
- K142206 — Dental Unit
- K142877 — EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
- K143379 — Liquichek Maternal Serum II Control
- K143386 — Progrip Laparoscopic Self-Fixating Mesh
- K141524 — NEURO-AUDIO
- K142352 — CardiacLinx
- K142634 — Biomet Spine Fusion System
- K142766 — I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear
- K142801 — Triton Canister System
- K142873 — OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners
- K143598 — Lapro-Clip Auto Suture Reusable Long Clip Applier
- K143662 — Bissinger Monopolar Forceps and Cables
- K133838 — STERILIZATION POUCH/ROLL MADE WITH TYVEK
- K141159 — KONUS DENTAL IMPLANT SYSTEM
- K141837 — DRX-EVOLUTION
- K142736 — XIDF-AWS801, Angio Workstation, v5.31
- K143316 — Attain Hybrid Guide Wire
- K150375 — LIAISON VZV IgG, LIAISON Control VZV IgG
- K141624 — PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113
- K142068 — BULLDOG BIOPSY VALVE, OLYMPUS AND FUJINON; PENTAX COMPATIBLE; DISPOSABLE RRIGATING ADAPTOR, STERILE AND NON-STERILE
- K142439 — Martinez Prostate Template Set
Data sourced from openFDA. This site is unofficial and independent of the FDA.