FDA 510(k) clearances — page 72
clearances on record, most recent first.
Clearances — page 72
7,101–7,200 of 176,479- K241496 — Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
- K241738 — PYXIS 3D Titanium Cervical Cage system
- K241848 — MedtFine Safety Lancet
- K242134 — ClearCap Distal Attachment
- K242189 — CELERITY HP Indicator Tape (PCC077)
- K240235 — OmniTrans Transport System
- K241023 — Negative Pressure Wound Therapy Device (V-Move, V-Grand)
- K241275 — Histolog® Scanner (Hardware 2.4, Software 3.3)
- K241282 — RibFix Titan Fixation System
- K241440 — HealthCCSng
- K241504 — iFuse TORQ TNT Implant System
- K241870 — OnPoint Augmented Reality Spine System
- K242432 — MT-Bone
- K240234 — BTL-899MS
- DEN230090 — First To Know Syphilis Test
- K222126 — VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose Monitoring System, VivaChek Fad Sync Blood Glucose Monitoring System
- K223700 — BOSS
- K231979 — Mecun SpO2 sensor
- K233499 — Sapphire NC ULTRA Coronary Dilatation Catheter
- K233700 — Avicenna Roboflex
- K233755 — HeartKey® Rhythm
- K233896 — JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus
- K240081 — Human Lubricant
- K240133 — Xenograft Bovine Bone Particulate
- K240307 — VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
- K240573 — iTero Lumina Pro
- K240740 — qCT LN Quant
- K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
- K241236 — XTRA Collection sets; XTRA Sequestration set X
- K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled)
- K242108 — Ambu® aScope 5 Uretero (Standard Deflection); Ambu® aScope 5 Uretero (Reverse Deflection); Ambu® aView 2 Advance
- K242127 — ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
- K242239 — HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
- K233505 — Sapphire ULTRA Coronary Dilatation Catheter
- K233965 — UltraDrape UGPIV Barrier and Securement (34-15)
- K240837 — TOV Dental Implant System
- K240961 — Disposable Pen Injector Assembly
- K241211 — CoLumbo
- K241401 — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
- K241522 — NPseal (20 and 25)
- K241596 — uMI Panvivo
- K241750 — Medifun Safety Lancet ( MSL1 series)
- K241754 — NCB® Polyaxial Locking Plate System +3 more
- K241810 — MICROLET®NEXT Lancet
- K242061 — Reusable Interface Cable 1.5 m (PRD-IFC-002)
- K232836 — Family of DIMAR DMAX NIV masks
- K240595 — Utepreva Endometrial Sampler (UP01)
- K240713 — TRAUMAGEL®
- K240957 — Catapult Guide Sheath
- K241510 — CROSSLEAD Tracker
- K241571 — BostonSight® Specialty Lenses
- K241748 — Intimate Rose Vaginal Dilators
- K241969 — Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel
- K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)
- K242059 — Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)
- K242077 — PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
- K240807 — VM-2000
- K241094 — Bullsai
- K241387 — CoLink NeoFuse MIS Plating System (see attached parts list)
- K241429 — ECHELON Synergy MRI System
- K241547 — Diode Laser Therapy Device (DF-DIODE LASER-S1)
- K241686 — Power wheelchair (N6101)
- K241699 — SUPER VELOCE
- K241813 — SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
- K241978 — Shinetell Digital Pregnancy Test
- DEN210037 — SoClean 3+ Bacterial Reduction Device
- K233367 — iDart Lyme IgG ImmunoBlot Kit
- K240868 — Ultravision2 IonPencil
- K241328 — aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF) +2 more
- K241365 — Pixie Pulse (SM9068)
- K241402 — Medical Monitor (32HR734S)
- K241656 — Eneka Selectif
- K241846 — E3D-C Interbody System
- K242054 — OptimMRI (v2)
- K242096 — dS FootAnkle Coil 8ch 1.5T
- K222688 — The Trust
- K231950 — MEDIDIODE
- K232404 — CHOLESTEROL; HDL-cholesterol; LDL-cholesterol; TRIGLYCERIDES
- K233643 — F&P Airvo 3 NIV (PT311US)
- K233697 — SonoMax Series Digital Color Doppler Ultrasound System
- K234053 — F&P Optiflow Flow Diverter
- K240079 — Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)
- K240469 — Access TPO Antibody
- K240664 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
- K241376 — HyperSuture All Blue Extension Line
- K242016 — EnSite X EP System
- K231775 — GR Resin System MSI
- K233312 — SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499) +2 more
- K233315 — HipXpert and HipInsight System
- K233356 — Illusion Aligner Pro: Illusion Aligner FLX
- K233702 — SMARxT Tubing and Connectors
- K233720 — Luminopia
- K233822 — i2Contour
- K233844 — OdneClean
- K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
- K240229 — Masimo W1
- K240724 — SynthVISION 1.0.0
- K241665 — Omni Legend
- K242009 — 360CAS Knee
- K212969 — Liposaver
Data sourced from openFDA. This site is unofficial and independent of the FDA.