FDA 510(k) clearances — page 77
clearances on record, most recent first.
Clearances — page 77
7,601–7,700 of 175,620- K233747 — Concha Sol Hearing Aids (CL-1001)
- K233748 — CIARTIC Move (VB10)
- K233799 — Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R)
- K233814 — 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M)
- K233881 — ivWatch® Model 400
- K233986 — BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL)
- K234104 — PICOANDY (Q-Switched Nd:YAG Laser)
- K234115 — APRO 55 Catheter
- K240112 — Light Cure Composite
- K240117 — Aventus Thrombectomy System (IM-2001/IM-0002)
- K240430 — Otoport Pro
- K240441 — MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw
- K240454 — RESPONDER® Polysaccharide Hemostat
- K240466 — STARband 3D
- K240539 — Vital Spinal Fixation System
- K240694 — FORMA Composite (Shade A3D)
- K231529 — CloudPoint FastDesign Chairside
- K231850 — QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments
- K232301 — Define RF Microneedling System
- K232567 — Myriad SPECTRA Light Source
- K232610 — da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation
- K232803 — NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
- K232980 — SpermAlign Sperm Separation Device
- K233542 — Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System
- K233853 — LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub
- K233958 — hekaDrill
- K232022 — CAS-One IR
- K233070 — Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
- K233136 — Hygeia Express Powered Breast Pump
- K233466 — Edison System
- K233592 — BioPoly Radial Head Implant
- K233930 — MRCP+ version 2 (MRCP+ v2)
- K233946 — IMMULITE® 2000 BR-MA
- K233949 — ACCORD Cable System
- K233952 — DEKA ACE Pump System
- K233968 — CINA-iPE
- K234002 — ICEfx Cryoablation System (FPRCH8000-02)
- K234008 — CERAMENT G
- K234055 — DEKA Loop
- K231849 — MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
- K232564 — Align Studio
- K233381 — DRX-Evolution Plus System
- K240132 — EmoLED (v. 2-USA)
- K240416 — Tranquil-C Interbody System
- K240424 — Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix
- K240497 — Smartxide Tetra Pro
- K231758 — NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)
- K231789 — Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
- K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100
- K232140 — OTS Hip
- K233724 — 28mm/38D MDM X3 Insert for MDM Liner
- K233912 — ARIX Cannulated Screw System
- K233922 — SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG
- K234000 — VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
- K234015 — Caphosol® Artifical Saliva (32 doses sachet box)
- K233083 — Osteon Precision Milled Suprastructure
- K230195 — Neo ADVISE software
- K231056 — Esperance Distal Access Catheter
- K231734 — STERiJECT Low Dead Space, STERiJECT The Invisible Needle
- K231760 — HP-OCT (HP-OCT)
- K231813 — Ultrasonic Gastrovideoscope
- K231904 — Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
- K232826 — Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824)
- K233038 — Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
- K233177 — Nest VT Vitrification Device
- K233198 — OSSIOfiber® Threaded Trimmable Fixation Nails
- K233359 — DOMINION Expandable Corpectomy System
- K233421 — RESCAN 700
- K233438 — SleepStageML
- K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro)
- K233705 — CellFX Percutaneous Electrode System (SYS3000)
- K233758 — Trivicta Hip Stem
- K233899 — Knee+
- K233943 — Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
- K234046 — WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
- K240264 — Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)
- K240384 — SENDERO Microcatheter
- K240396 — Elite iQ PRO (M122K1)
- K232207 — D·Kutting PTA Scoring Balloon Dilatation Catheter
- K232781 — Safety Sliding Blood Collection Set
- K233692 — Voluson Signature 20, Voluson Signature 18
- K240371 — 0909FCC, 0909FCC-HS
- K240407 — ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor
- K240458 — Synthetic Bone Putty
- K231403 — evoDrill Cranial Perforator
- K231497 — Choledochoscope System
- K231677 — EdgeFlow UH10
- K231786 — Gynethotics Pessary
- K232004 — Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector
- K232270 — DVT Motion Pneumatic Compression Device
- K232424 — CurrentBody Skin RF
- K232703 — Disposable Bipolar Forceps
- K233021 — BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device
- K233075 — BioGend Interbody Fusion System 001 Cage
- K233572 — Autofuse
- K233794 — Insulin Syringe
- K233880 — Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141)
- K240273 — Access Free T4
- K240351 — FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
- K240352 — Defendo Single Use Cleaning Adapter for Olympus Endoscopes
Data sourced from openFDA. This site is unofficial and independent of the FDA.