FDA 510(k) clearances — page 74
clearances on record, most recent first.
Clearances — page 74
7,301–7,400 of 176,479- K240401 — ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
- K240509 — STAR Apollo Mapping System
- K241028 — Luja female (4 models)
- K241078 — Tandem Mobi Insulin Pump with interoperable technology
- K241187 — Alien Aligners
- K241494 — Pantheon Pedicle Screw and Iliac Bolt Fixation System
- K241515 — NEXA NPWT System
- K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
- K241845 — Introcan Safety® 2 IV Catheter
- K241866 — InnovaMatrix®FD
- K241883 — DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00) +4 more
- K241898 — Symbia SPECT and SPECT/CT Systems
- K233372 — KARL STORZ Fiber Telescopes for Urology
- K233563 — Navident
- K240886 — Fluent Pro Fluid Management System (FLT-200) +4 more
- K241063 — s-Clean ScanHealing Abutment
- K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH)
- K241171 — Spine Guidance Software (Version 5.1) +4 more
- K241203 — PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)
- K241361 — Arthrex Synergy Vision Endoscopic Imaging System
- K241864 — Grappler Interference Screw System
- K241887 — GI Genius Module 100 (GGM100.US) +4 more
- K230305 — THE Graft Collagen
- K231251 — FlexWing Anterior Cervical Plate System
- K233352 — Aptima HCV Quant Dx Assay
- K233865 — X-Smart Pro; X-Smart Pro+
- K240044 — CADDIE
- K240431 — ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface
- K240457 — C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
- K240714 — Insure® Universal; Insure® Universal Automix
- K240780 — InMode RF System
- K241130 — POINT Kinguide Agile Hybrid Navigation System (PSHF01-000)
- K241150 — MISTI Silicone Implant
- K241243 — Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters) +1 more
- K241502 — P-SCOPE
- K241789 — Non-Sterile Ultrasound Transmission Gels
- K241863 — Erisma® Lp Spinal Fixation System; Erisma® LP MIS
- K240756 — AITRICS-VC
- K240906 — TE Air Diagnostic Ultrasound System
- K241114 — EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)
- K241296 — Gaudi Proximal Humerus Plate
- K231133 — neo315
- K234091 — Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
- K240339 — Electric Wheelchair (Robooter E60) (8 models)
- K240558 — NAVOYCDS
- K240704 — ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System
- K241116 — Onycho Laser V
- K241119 — Transcutaneous Electrical Nerve Stimulator (K6106)
- K241445 — K-Bond Universal
- K241482 — Kinos Total Ankle System
- K240347 — PTG-05
- K233067 — Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
- K233866 — Senhance Surgical System
- K233976 — VasoGuard (V10, V8, V6, V4, V2)
- K233979 — VACUETTE® QUICKSHIELD Complete (Plus)
- K240480 — IntelliBlate Microwave Ablation System Console (IB-CON) +4 more
- K240538 — Premium Teeth Resin
- K240835 — Suture Button Repair System
- K241809 — coactiv+ Antimicrobial Wound Gel
- K212521 — Field Shield Wound Dressing
- K221495 — SOLID CLIP Single Use Clip Applier
- K233482 — Equinoxe® Central Screw Baseplate System
- K233768 — Papacarie Duo
- K233917 — ICHOR 7F Embolectomy System (ICH-7F)
- K234029 — CEFALY Connected - OTC, CEFALY Connected - Rx
- K240340 — Surgical Drive System (Model: ES70, ES90, E8)
- K240821 — B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
- K241060 — HardyDisk AST Cefiderocol 30µg (FDC30)
- K241206 — Quantum Perfusion Hybrid System
- K241240 — Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
- K241321 — Juliet® Ti LL Lumbar Interbody Device
- K241463 — Electric Wheelchair (MP201C); Electric Wheelchair (MP201L)
- K241879 — vRad Viewer
- K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
- K240503 — Sonata Transcervical Fibroid Ablation System 2.2
- K240609 — S.I.N. Dental Implant System
- K240705 — Vitrea Software Package, VSTP-002A V2.0
- K240845 — Rayvolve
- K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System
- K241121 — MICSI-RMT
- K241413 — sagAlign Lumbar Cage System (Various PNs)
- K241467 — Stable-C Interbody System
- DEN230061 — allay Nerve Cap
- K233778 — Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH)
- K240272 — Electric Scooter (M2085, S2091)
- K240944 — Swoop® Portable MR Imaging® System
- K241050 — CrossRoads Modular Tray System
- K241056 — Light Cure Adhesive
- K241441 — RadiForce RX670; RadiForce RX670-AR
- K241740 — Finesse Injectable PTA Balloon Dilatation Catheter
- K241741 — SAFElife Fentanyl Urine Home Test (Cassette) +3 more
- DEN230092 — Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
- K233449 — Avantik VTM
- K233458 — CM005 Standard (CM005); CM004 Mini (CM004)
- K233460 — CM00622 LINC Skin Closure System (CM00622 LINC)
- K240178 — RFG-01
- K240285 — Huxley SANSA Home Sleep Apnea Test (1000-00)
- K240616 — FAQ (102)
- K241032 — BellaTek Bars
- K241739 — Endoscopic Applicator, 41 cm
Data sourced from openFDA. This site is unofficial and independent of the FDA.