FDA 510(k) clearances — page 350
clearances on record, most recent first.
Clearances — page 350
34,901–35,000 of 176,542- K151586 — Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens
- K140907 — LEECH, MEDICINAL
- K143017 — Urgoclean Ag, Antibacterial Absorbent Wound Dressing with Silver
- K143758 — PerioType Rapid
- K150022 — Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
- K150665 — Philips Spectral CT Applications
- K151164 — Assure Prism multi Blood Glucose Monitoring System
- K151241 — Synchro-Medical TIGER TRACK Screw System
- K151353 — syngo.MR Neurology, syngo.MR Oncology
- K151369 — .decimal p.d
- K151373 — Corvocet Coaxial Introducer
- K151409 — Selectra Catheters and Selectra Accessory Kit
- K151583 — Digital Automatic Wrist Blood Pressure Monitor MD3900
- K151587 — Digital Automatic Wrist Blood Pressure Monitor MD3200
- K151653 — 8ch Foot Ankle Coil
- K151657 — Shielded Applicator Set, Cervical Stop
- K151863 — Precision Spine Interspinous Plate System
- K151867 — STA R MAX
- K151877 — MicroTract Access System
- K151880 — Wingman Crossing Catheter
- K151924 — Q-Rad Radiographic System with Auto-Tracker Option
- K152054 — Confida Adaptive Sheath
- K142689 — GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System
- K143534 — Elecsys CA-125 II assay
- K143752 — Total Knee Application (TKA)
- K150095 — ReDs Wearable System
- K150398 — EUM 100Pro
- K150614 — Reveal LINQ
- K150819 — Triglycerides
- K151000 — O-Arm O2 Imaging System
- K151061 — Cornea Cold
- K151128 — CAPSTONE Spinal System, CLYDESDALE Spinal System
- K151232 — VIKINI Diode Laser System
- K151235 — Medline Foot Plates and Screws
- K151374 — NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System
- K151623 — Penumbra System 110 Aspiration Tubing
- K151802 — Resolution Clip
- K151856 — ABL80 FLEX CO-OX with AQURE connectivity
- K151879 — VariAx 2 One-Third Tubular Plating System
- K151897 — MultiFIX® P Knotless Fixation Device
- K132929 — SD GLUCONAVII MENTOR NFC MULTI BLOOD GLUCOSE MONITORING SYSTEM, AND SD GLUCONAVII MENTOR NFC BLOOD GLUCOSE MONITORING SYSTEM
- K143700 — CPAP Cannulaide
- K150086 — Titan
- K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System
- K151023 — COMPACT PIEZO LED
- K151157 — NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges
- K151286 — OPTIS Integrated System Mobile Workstation
- K151818 — SImmetry Sacroiliac Joint Fusion System
- K143292 — TheraCal DC
- K143554 — Venus Legacy CX
- K150735 — Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot
- K150871 — ForeFoot STP System
- K150929 — CareView 1500Cw X-ray Flat Panel Detectors
- K150973 — NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs
- K151219 — Models 2200DR and 1600DR Digital Stationary Radiographic Systems
- K151325 — Bovie J-Plasma Handpiece
- K151561 — Leksell Gamma Knife Icon
- K140432 — HI-LIGHT, HI-LIGHT PLUS
- K142943 — Metallic Locking Bone Plate and Screw
- K150465 — Medtronic Confida Brecker Guidewire
- K150865 — Metacross RX PTA Balloon Dilitation Catheter
- K151687 — QuantorView
- K141970 — DIGITEK TITANIUM ABUTMENT
- K142040 — OCS-B COLLAGEN
- K142813 — Biogensis Implant System-Kisses
- K143219 — NIRO-200NX
- K143418 — STRONG Dental Handpieces
- K143532 — Durex Silicone
- K143676 — B40i Patient Monitor
- K150021 — Z5m(t)
- K150068 — Unimicro Veress Needle
- K150214 — OneTouch Verio Flex Blood Glucose Monitoring System
- K150641 — MagVita TMS Therapy System
- K150752 — GME ExSys 308
- K150874 — NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
- K151053 — PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner
- K151204 — HEMO-Bandage
- K151363 — Zephyr Vascular Compression Device
- K151483 — Biomet Spine Fusion System
- K151568 — Arthrex OrthoVis Preoperative Plan
- K151813 — Sniper Spine System
- K151904 — SyncVision System
- K151963 — SmartSite Vented Vial Access Device
- K142790 — OneTouch Lubricant Gel
- K150316 — Polypectomy Snare
- K150371 — Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
- K151177 — XenMatrix AB Surgical Graft
- K151199 — SmartDrive Wheelchair Power Assist
- K151298 — Gemini XXP-HP
- K151883 — 5MP Monochrome LCD Monitor, RadiForce GX540
- K151889 — Infinity ERCP Sampling Device
- K143277 — Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl Patient Examination Glove (Non-Sterile),
- K143278 — LnK Posterior Cervical Fixation System
- K143368 — GenIQ
- K150107 — Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
- K150377 — Sony LMD-X310S LCD Monitor, Sony LMD-X310MD LCD Monitor, Sony LMD-X310NB LCD Monitor, Sony LMD-X550S LCD Monitor, Sony LMD-X550MD LCD, Sony LMD-X550NB LCD Monitor
- K150505 — Cellfina System
- K151015 — ECHELON Oval V 5.0 MRI System
- K151808 — 3D/5D Viewer
- K151829 — Atlas SPEEDER Header/Neck
Data sourced from openFDA. This site is unofficial and independent of the FDA.