FDA 510(k) clearances — page 342
clearances on record, most recent first.
Clearances — page 342
34,101–34,200 of 175,770- K151702 — Reusable Full Silicone Cover
- K151801 — Arc Endocuff Vision
- K151981 — Turnpike catheter
- K150564 — Spaulding Electrocardiograph 2100iQ
- K151064 — Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System
- K151256 — Arthrex BioSync® Bone Wedge
- K151407 — RECON system
- K151462 — SI-TECHNOLOGY® SI-DESIS® SCREWS
- K151663 — RS80A Diagnostic Ultrasound System
- K151776 — Central Venous Pressure System
- K151859 — Synapse Cardiovascular
- K151929 — PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE
- K151935 — Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only
- K151947 — LightSheer Desire Light Laser System
- K142765 — TM SAFETY NEEDLE
- K143148 — Disposable Pressure Manometer (DPM)
- K143583 — Cathivex ¿GV filter units
- K150745 — syngo.CT Single Source Dual Energy
- K150757 — syngo.CT Dual Energy
- K151850 — McKesson Cardiology
- K141594 — Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar
- K150395 — Omega LIF System
- K150814 — Straumann Screw-Retained Abutment
- K150928 — Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides
- K151057 — WASTON Metallic Bone Plate and Screw Systems
- K151216 — Everest Spinal System
- K151247 — NC Straumann Screw Retained Abutments
- K151264 — Restoration Anatomic Shell
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.