FDA 510(k) clearances — page 286
clearances on record, most recent first.
Clearances — page 286
28,501–28,600 of 175,699- 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
- K170661 — Novosyn Quick Absorbable Suture
- K170681 — Continuous Single Culture -NX (CSCM-NX)
- K170763 — Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend
- K170821 — ChoiceSpine Proliant® Posterior Pedicle Screw and Hook Fixation System
- K170961 — NuVasive CoRoent Small Interlock II System
- K170967 — Intraskan DC Plus
- K171066 — BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
- K171086 — Accuray Precision Treatment Planning System
- K171112 — Trifore(tm) Cervical Plating System
- K171222 — Vitrea Software Toshiba Package; VSTP-001A
- K171256 — Quingo Flyte Mobility Scooter
- K160673 — Insulin Algorithms System
- K162109 — Kwart Retro-Inject Ureteral Stent
- K162564 — Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System
- K163357 — OneTouch Via On-Demand Insulin Delivery System
- K163531 — Advanced Perfusion System 1
- K163679 — Digital Automatic Blood Pressure Monitor MD3600
- K170144 — StentBoost Live
- K170250 — SmartTarget
- K170354 — Straumann Variobase Abutments
- K170356 — Straumann Variobase Abutments
- K170412 — Vantage Titan 1.5T, MRT-1510, M-Power GX
- K170602 — Continuous Single Culture-NX Complete (CSCM-NXC)
- K170728 — E. HISTOLYTICA QUIK CHEK
- K170736 — HySil Impression Materials
- K170751 — MRIdian Linac System with 138-leaf Collimator
- K170772 — Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
- K171088 — Cochlear Baha SoundArc
- K171335 — Venture 038 catheter
- K171353 — CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris
- K171357 — SurgiMend PRS Meshed, Revize-X
- K161420 — MOVES SLC
- K162372 — QT Ultrasound Breast Scanner-1
- K163603 — Digital Thermometer
- K170044 — Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System
- K170155 — EK12 Algorithm
- K170374 — SonoBook Series Diagnostic Ultrasound System
- K170591 — Altomed Malhotra Platinum Segments
- K170687 — Flower Bone Screw Set
- K170709 — CURVE Laser System
- K171347 — Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
- K171429 — Magnetic Surgical System
- K163228 — APVolution System
Data sourced from openFDA. This site is unofficial and independent of the FDA.