FDA 510(k) clearances — page 280
clearances on record, most recent first.
Clearances — page 280
27,901–28,000 of 175,699- K170984 — LG BEAUTY LED MASK
- K171244 — Physiotrace
- K172104 — Ozark(tm) Cervical Plate System
- K172214 — Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters
- K172227 — Endoscopic Injection Needle
- K172262 — EVOS Small Fragment Plating System
- K162540 — INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
- K163342 — i-STAT Hematocrit test with i-STAT Alinity System
- K163695 — Borrelia B31 ViraChip IgM Test Kit
- K170642 — GRAVITY Soft Tissue Repair System
- K170911 — NEOCERA Advanced Barrier Cream
- K171041 — SilverSeal
- K171140 — Matrixx System
- K171504 — VERIFY Assert VH2O2 Self-Contained Biological Indicator
- K171523 — Monopolar Single Use Laparoscopic Instrument
- K171587 — VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator
- K171617 — OKI Surgical Planning Software
- K171895 — Grivamax Hair Growth System
- K172364 — EzDent-i / E2 / Prora View
- K172367 — Stryker Integrated Bipolar Cord and Tubing Sets
- K163375 — INFINITY OCT System
- K171024 — ShockPulse-SE Lithotripsy System
- K171225 — Sorbact Wound Dressing-Ribbon Gauze
- K171276 — Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs
- K171452 — MAMBA and MAMBA FLEX Microcatheters
- K171459 — Ceribell Instant EEG Headband
- K171511 — RIDA GENE Norovirus GI/GII
- K171526 — Zenius, lliad and Kora Spinal Fixation Systems
- K171897 — Approach CTO Microwire Guide
- K172107 — Threshold V2 Pedicular Fixation System, Threshold Pedicular Fixation System, Fortress Pedicular Fixation System, Palisade Pedicular Fixation System
- DEN160025 — ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
- K161679 — s LDL-EX SEIKEN
- K163359 — ARK Methotrexate Assay
- K163418 — Diazyme DZ-Lite Total beta-hCG Test System
- K170003 — Zip 4 Skin Closure Device
- K170149 — 3DMetal Tibial Cones
- K170431 — CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip
- K170667 — QEVO System with KINEVO 900
- K170782 — Medline UNITE® Snap-Off Screws
- K170800 — NuVasive LessRay with Enhanced Tracking
- K170825 — SnoreRx
- K171143 — Relievant Medsystems RF Generator
- K171183 — OmniTom
- K171227 — StarWalker
- K171261 — ScannerSide DoseCheck
- K171406 — Optum TeleHealth Application
- K171407 — ExsoMed ArcPhix and ExsoMed ArrowPhix
- K171660 — Duo Lumbar Interbody Fusion Device
- K171738 — Supria True64
- K171845 — EMBA Hourglass Peripheral Embolization Device
- K171898 — Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs
- K171900 — Acclarix AX4 Diagnostic Ultrasound System
- K172139 — Streamline OCT Occipito-Cervico-Thoracic System
- K172182 — QUANTIEN Measurement System
- K172194 — Connector System
- K172216 — ACIST RXi Mini System
- K172359 — UroLift System (UL500)
- K162917 — Allerhope Allergy Skin Tester
- K163321 — Rocket Indwelling Pleural Catheter (IPC) Insertion Kit
- K163339 — SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
- K163500 — IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)
- K170384 — Dentium NR Line CAD/CAM Abutments
- K170531 — Ureteral Dilators and Percutaneous Nephrostomy Dilators
- K170555 — U Deliver Bolink ENFit Enteral Feeding Sets
- K170979 — ARIX Ankle Fibula Hook Plate System
- K171028 — CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories
- K171156 — OMNI Anseris Hip Stem
- K171475 — DeRoyal Laprador Specimen Retrieval System
- K171793 — Sequential Circulator SC-2004FC-OC
- K171983 — Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
- K171993 — Zimmon Needle Knife Papillotome
- K172165 — Q-Fix Suture Anchor
- K172204 — BD Intima II PLUS Closed IV Catheter System
- K172220 — Advanced Perfusion System 1
- K162768 — ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables
- K163568 — SHOFU RESIN GLAZE
- K170064 — GLUCOCARD W Blood Glucose Monitoring System
- K170910 — Medacta Anatomic Shoulder Prosthesis
- K170968 — PROPHECY INVISION Pre-operative Navigation System
- K171651 — EXCELSIUS GPS
- K171950 — Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B)
- K172162 — ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems
- K172175 — CapSure® PS System
- K172426 — Clear Blue Digi LED Curing Light
- K163483 — PANA SPRAY Plus
- K163570 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
- K170222 — Rapid Tox Cup II
- K170872 — Aisys CS2
- K171118 — Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s)
- K171162 — Surgical Earloop Face Mask with Bottom Gap Shield and Surgical Tie-On Face Mask with Bottom Gap Shield
- K172163 — Eclipse Treatment Planning System
- K172374 — ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System
- K163398 — ATLANTIS suprastructures
- K170321 — 3M Comply Hydrogen Peroxide Chemical Indicator 1248
- K170780 — ARIX Foot System (2.3/2.8)
- K171332 — Artemis Neuro Evacuation Device
- K161225 — Paonan Armstrong Posterior Spinal Fixation System
- K162729 — Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
- K162977 — ADVIA 2120i, ADVIA 2120
- K163166 — EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only
Data sourced from openFDA. This site is unofficial and independent of the FDA.