FDA 510(k) clearances — page 97
clearances on record, most recent first.
Clearances — page 97
9,601–9,700 of 175,620- K222439 — Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
- K223633 — Rubicon Control Support Catheter (H749394323506A1)
- K223924 — LW Implant System
- K230551 — Visual-ICE Cryoablation System
- K230620 — Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter
- K231857 — Arthrex TightRope II
- K232008 — Disposable Medical Examination Nitrile Gloves
- K232052 — Ceribell Instant EEG Headband
- K232100 — Efai Pacs Picture Archiving and Communication System Pro
- K220828 — SQA-iO Sperm Quality Analyzer
- K223476 — V-PRO maX 2 Low Temperature Sterilization System
- K223713 — Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K230376 — Reprocessed Agilis NxT Steerable Introducer
- K231098 — LineSider® Spinal System
- K231488 — Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape
- K231490 — Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator
- K231500 — Vis-U-All Low Temperature Sterilization Pouches
- K231501 — PRO-LITE Sterilization Tray
- K230733 — Stryker Resorbable Fixation System
- K220031 — Alinity h-series System
- K221138 — Titus Titanium Cervical by SAGICO
- K222635 — Premier Resolution System
- K223431 — Citric Complete Liquid Citric Acid Concentrate
- K223507 — CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE)
- K223673 — Surgeon Controlled Arm
- K223787 — ECGenius System
- K230126 — Dentis s-Clean Regular Abutment
- K230672 — Annabella Breast Pump
- K231333 — STRETTO Cable System
- K231370 — Dewin Blastocyst Medium (with HSA and without HSA)
- K231400 — Bladeless Trocar Artemis Lap Cannula
- K231404 — T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button
- K232005 — HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid)
- K232006 — LEGACY® IPC
- K232010 — iTEMPSHIELD
- DEN230003 — Viz HCM
- K221894 — Lumbar Expandable lnterbody Spacers -Additional Indications/Implants
- K223122 — MENIX®; MENIX® DUO
- K223133 — VisiRad XR
- K223542 — TubaVent Balloon Dilatation System
- K223551 — Sterile Water for Inhalation in 1L Flexoval ® bottles.
- K230380 — Surgical Face Masks, Model: EFMDS-L50Pn BLU
- K230419 — Sequel Tampon with Plastic Applicator
- K231458 — Extremity Staple
- K231548 — Medical Diode Laser, Model S1Pro
- K231654 — NorthStar OCT System
- K231831 — TiLink-L Joint Fusion System
- K232015 — ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)
- K232058 — YosemiteView 4343W/YosemiteView 3643W
- K232132 — LifeSPARC System
- K221114 — Immunoglobulin G (IgG)
- K223114 — Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
- K223553 — Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
- K223689 — Disposable Needle Guides and Grids
- K223821 — Self-Cath Closed System
- K230613 — SKEEPER
- K230748 — Disposable Ureteral Access Sheath
- K231126 — Eblator Device
- K231174 — BPBIO750
- K231286 — Chemfort® Catheter Adaptor
- K231344 — ActivSight Intraoperative Imaging System
- K231593 — Sapphire X3 Anterior Cervical Plate System
- K231942 — Mineral Collagen Composite Bioactive Extra Moldable
- K232030 — Ingenia Elition R5.7.1 SP4 MR Systems
- K230162 — uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis
- K230873 — Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
- K231278 — Knotless Suture Anchor
- K231602 — Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing
- K231620 — Nuubo Smart
- K231954 — Aristotle 18 Guidewire; Aristotle 24 Guidewire
- K231959 — EXPD 4357; EXPD 4357P
- K231963 — REAL INTELLIGENCE CORI
- K221767 — Surgical Sutures with or without Needle
- K223097 — RenaNav Ureteroscope System
- K223567 — CNS-2101 Central Monitor
- K230004 — Disposable Hemoclip
- K230630 — ZENEX Implant System_Narrow
- K230858 — QUATERA 700
- K230956 — BD Respiratory Viral Panel for BD MAX System; BD Respiratory Viral Panel-SCV2 for BD MAX System
- K231321 — Nooance Led And Laser Helmet
- K231591 — V-Print c&b temp
- K231613 — Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.
- K231698 — AllTest Fentanyl Rapid Test (Urine)
- K232088 — Altris IMS
- K222862 — SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC
- K222587 — PatCom Distal Chip Endoscope
- K222735 — HJY VisualNext Endoscopic Vision System
- K222794 — FlowStar Touch Digital Mixer Flowmeter
- K222902 — Electrocardiograph: SE-1200 Pro and SE-1201 Pro
- K223670 — MESI mTablet ECG Diagnostic System, MESI mTablet ECG
- K223710 — i-STAT CG8+ cartridge with the i-STAT 1 System
- K223781 — Quantisal II Oral Fluid Collection Device
- K230801 — Pathfinder Endoscope Overtube with Balloon Device
- K230813 — BlueStar and BlueStar Rx
- K230898 — FLUOBEAM® LX Red
- K231073 — SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
- K231249 — PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
- K231313 — Therapy Mask 3100 NC/SP
- K231480 — Bright MTA Sealer Plus
- K231552 — Dia-Cem
Data sourced from openFDA. This site is unofficial and independent of the FDA.