FDA 510(k) clearances — page 77
clearances on record, most recent first.
Clearances — page 77
7,601–7,700 of 176,479- K240465 — O-arm O2 Imaging System
- K240631 — V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
- K240643 — MissLan® Early Detection Pregnancy Test Strip +2 more
- K240649 — Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW)
- K240663 — Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
- K240728 — CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test
- K240862 — Medicom Sterilization Wrap
- K241117 — M6-C Single Use, Disposable Instrumentation
- K241442 — eZSURE Empty Fluid Container with ProSeal Injection Site
- K241459 — MOTUS PRO Family
- K241476 — ToxiSeal Vial Adaptor with External Flip Balloon
- K241519 — Invictus® Small Stature Spinal Fixation System
- K230675 — VITEK REVEAL GN AST Assay and VITEK REVEAL AST System
- K232161 — DeepRhythm Platform
- K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
- K233158 — Copra Smile, Copra Supreme Hyperion
- K233162 — Freedom Peripheral Nerve Stimulator (PNS) System
- K233225 — SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
- K240611 — IVYLASER Diode laser hair removal system (IVY-HR-Alloy)
- K240613 — APTUS Elbow Dorsal Olecranon Plates
- K240642 — SMART Bun-Yo-Matic CT
- K240669 — ACTIFY 3D Total Knee System, ACTIFY Total Knee System
- K240673 — Electric wheelchair
- K240688 — RODIN Titan 3D Resin
- K240830 — Reef TO/TA System +10 more
- K241435 — Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue +3 more
- K241466 — Shoreline ACS Interbody System +10 more
- K241627 — Safety Lancet (XXXV)
- K232997 — EVIS Exera III Gastrointestinal Videoscope GIF-1TH190
- K233036 — Ultrasonic Surgical System
- K233294 — Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
- K233553 — MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
- K233867 — Fitbone Trochanteric
- K240196 — Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
- K240552 — Irrisept Antimicrobial Wound Lavage
- K240583 — IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W)
- K240678 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
- K240774 — Pen Injector
- K241412 — Invisalign System
- K232258 — XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter
- K233060 — Elecsys Folate III
- K233255 — CROSSNAV Navigation Enabled Instruments
- K233256 — Robotic Integration Instruments
- K233324 — Molecular Transport Media - MTM
- K233331 — MediOMx
- K233987 — VERABAND
- K240684 — Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System
- K240747 — Medical Diode Laser (M2-GK)
- K241416 — Ion 3D
- K241428 — AllTest Multi-Drug Urine Test Cup; AllTest Multi-Drug Rapid Urine Test Cup
- K231116 — Multi-parameter detector
- K241469 — iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask
- K230668 — Disposable High-pressure Extension Lines
- K232812 — Fluidshield* 2 Fog-Free Surgical Mask (62113) +3 more
- K232879 — Roche Digital Pathology Dx (VENTANA DP 200)
- K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)
- K233043 — Smart Scope® CX
- K233079 — Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS) +4 more
- K233228 — Spine Navigation and Robotic-Assistance Device
- K233238 — Air Pressure Therapy System (Model:VU-IPC4M)
- K233254 — TELIGEN System Navigation Ready Instruments
- K233496 — EndeavorOTC
- K233707 — HFT150
- K233955 — Clarius OB AI
- K233991 — CanGaroo RM Antibacterial Envelope
- K240002 — G-Vitri Vitrification Straw
- K240124 — BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA Reader
- K240696 — Airdog X8 Air Purifier (KJ800F-X8)
- K240721 — ExcelsiusFlex
- K240729 — Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)
- K240817 — VersaWrap
- K241082 — INNOVERSE Navigation Instruments
- K241083 — SIS System
- K241250 — 3DMax Light Mesh
- K241407 — Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
- K231060 — ProMin Dental Desensitizing Gel
- K232930 — VERVE
- K232953 — AquaBplus; AquaB LITE
- K233321 — Double Balloon Endoscope EN-840T, Over-tube TS-1214C
- K233662 — Radiography 7300 C
- K233821 — F&P Optiflow Oxygen Kit (AA451J)
- K233892 — 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)
- K233925 — Relu Creator
- K240017 — InMode System with the Morpheus8 90 Applicator
- K240149 — Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium
- K240460 — FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
- K240815 — Arthrex Cannulated Screw System
- K241358 — BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
- K241370 — Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)
- K241499 — 21.3 5MP Color LCD Display UMD5-21B01
- K232950 — Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
- K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
- K233007 — Picosecond Nd:YAG Laser System; PICO LEGEND
- K233266 — MEDIBLU ECG SYSTEM
- K233610 — ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System
- K233613 — ACUSON SC2000 Diagnostic Ultrasound System
- K240050 — SOUNDSTAR CRYSTAL Ultrasound Catheter
- K240256 — Remunity System
- K240504 — PLASMA EDGE System
- K240516 — RS85 Diagnostic Ultrasound System
Data sourced from openFDA. This site is unofficial and independent of the FDA.