FDA 510(k) clearances — page 294
clearances on record, most recent first.
Clearances — page 294
29,301–29,400 of 176,542- K162588 — Möller Medical Biopsy Needles and Systems
- K162641 — Smith & Nephew, Inc. R3 Constrained Liner
- K162788 — ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
- K162886 — DEKA MOTUS AX
- K163029 — Hydris Oral Rinse
- K163506 — Coalesce (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System
- K170669 — Insulia Diabetes Management Companion
- K170693 — Phantom Small Bone Intramedullary Nail System
- K170893 — Materialise Glenoid Positioning System
- K170903 — Compex Wireless USA
- K161533 — A1C EZ Glycohemoglobin Analysis System
- K161582 — DORA Tubing Sets for Hemodialysis
- K162215 — Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
- K162659 — Diode Laser Hair Removal System
- K162674 — BioPro Foot Plating Systems
- K163676 — Silhouette InstaLift
- K170066 — Green16/Green18 (Model: PHT-65LHS)
- K170191 — SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System
- K170474 — Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter
- K170843 — Alians Fragment Specific
- K170909 — Infinix INFX-8000V, V6.40
- K171223 — Quantum TTC Biliary Balloon Dilator
- K171481 — MagVita TMS Therapy System
- K171538 — Cure Lumbar Plate System
- K161177 — Axiom PX
- K162459 — AccuPoint Electrode
- K162673 — Aptima Herpes Simplex Viruses 1 & 2 Assay
- K162749 — FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
- K162826 — Encore Neutral
- K163084 — Merit Coronary Control Syringe
- K163632 — Katalyst Cyclophotocoagulation Probe
- K170198 — Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
- K170263 — AcuNav Diagnostic Ultrasound Catheter 8F,10F
- K170288 — BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell
- K170499 — sensiLift
- K170569 — SeaSpine Shoreline ACS - Anterior Cervical Standalone System
- K170803 — HydroMARK Breast Biopsy Site Markers
- K170806 — ATTUNE Cemented Tibial Base, Fixed Bearing
- K170849 — SIMPLANT Guide
- K170850 — Alma Q
- K170992 — AcuNav V 10F Ultrasound Catheter
- K171494 — TroClose1200, TroClose1200 Cannula
- K160890 — Howell Biliary Introducer Needle
- K161216 — Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
- K161970 — Follicle Aspiration Set
- K162719 — iTotal® Hip Replacement System
- K163420 — UltraScore Focused Force PTA Balloon
- K163467 — C-Line Orthodontic Ceramic Bracket
- K170238 — BodyTom Elite
- K170396 — MAGNETOM Vida
- K170457 — EVOS Small Fragment Lower Extremity Plates
- K170847 — EchoPAC Software Only, EchoPAC Plug-in
- K170848 — Alzair Allergy Blocker
- K170878 — Vivid S60N, Vivid S70N
- K170966 — TONOPORT VI
- K171231 — Endoform Topical Matrix
- K171484 — hema-screen SPECIFIC Gold
- K160753 — COOK Vacuum Pump
- K163060 — Deep Conical (DC) Implants and Accessories
- K163079 — HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System
- K170325 — SECRET RF
- K170713 — da Vinci Xi Surgical System
- K171111 — Sculpsure
- K171426 — da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree
- K171427 — Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette
- K171468 — FUSE Spinal System
- K161354 — MELODY, Remote Control System for Ultrasound Probe
- K162625 — SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters
- K162755 — Picocare
- K162986 — SPIRA Open Matrix ALIF
- K170823 — Vivid E80, Vivid E90, Vivid E95
- K171417 — 1417WGC_127um and 1417WGC_140um
- K171418 — 1417WCC_127um and1417WCC_140um
- K171437 — SonoSite X-Porte Ultrasound System
- K171509 — Iliad® Pedicle Screw System and Zenius® Pedicle Screw System
- K161883 — CompuFlo Epidural Computer Controlled Anesthesia System
- K162569 — YES oil-based Personal Lubricant, YES Water-based Personal Lubricant, YES Vaginal Moisturizer
- K162685 — 2-Piece Hammertoe Correction System
- K163313 — ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor
- K163475 — iVue
- K163636 — ePlex Respiratory Pathogen Panel
- K163652 — ePlex Instrument
- K170169 — PRECICE Intramedullary Limb Lengthening System
- K170515 — Sterile Nitrile Surgical Gloves, Powder-free
- K170730 — JAZZ System, including JAZZ Band
- K170747 — syngo Application Software
- K170762 — Cardinal Health Non-Reinforced Surgical Gown
- K170792 — Diamondback 360 Peripheral Orbital Atherectomy System
- K170996 — Wingman 14C Crossing Catheter
- K171419 — 1717SGC_127um and 1717SGC_140um
- K171420 — 1717SCC_127um and 1717SCC_140um
- K161327 — SYNTEC HUMERAL NAIL SYSTEM
- K162610 — NEXA Negative Pressure Wound Therapy System
- K162689 — Vibrance Pelvic Trainer
- K162996 — INVISIKNOT Ankle Syndesmosis Repair Kit
- K163193 — UTF Stem, reduced, #0, #00
- K163580 — ASD Oral Appliances
- K170101 — Valiant Curing Light
- K170366 — Laser Peripherals, LLC Family of Bare Laser Fibers
- K170460 — Sorin Connect
Data sourced from openFDA. This site is unofficial and independent of the FDA.