FDA 510(k) clearances — page 106
clearances on record, most recent first.
Clearances — page 106
10,501–10,600 of 176,479- 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
- K231589 — Blood Tubing Lines for Hemodialysis AV06C-E
- K231618 — 3 Layer Surgical Mask (134252531)
- K231931 — Adena-Zina Spinal System
- K231951 — SI-Cure Sacroiliac Joint Fusion System
- K212077 — Teleflex Rusch SoftSimplastic Foley Catheters
- K223591 — cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
- K230074 — Rapid Aneurysm Triage and Notification
- K230838 — Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets
- K231044 — R2P Navicross
- K231195 — Brainomix 360 Triage ICH
- K231221 — MDx-Chex for BC-GP
- K231223 — MDx-Chex for BC-GN
- K231236 — IBS-B MIS Beveled Screw System
- K231261 — Altaviz Needle Kit II
- K231555 — LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
- K231886 — SURGIVISIO Device
- K231912 — Therm-X
- K220765 — HS Fiber Cerclage
- K222874 — CarboClear Cervical Cage System, CarboClear Cervical VBR System
- K222994 — Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
- K231038 — Global Hypoperfusion Index (GHI) Algorithm
- K231172 — ApolloKnee
- K231572 — uMI Panorama
- K231787 — ecoFIX®
- K231922 — DEPUY SYNTHES MAXFRAME AUTOSTRUT System
- K213536 — DEKA ACE Pump System
- K221605 — Emit® II Plus Buprenorphine Assay
- K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl)
- K223473 — ME-APDS; MAGENTIQ-COLO
- K230365 — Sonio Detect
- K230455 — Enamel Coating Resin
- K230540 — Patient Specific Planning Solution 3D Bone Models
- K230576 — IDENTIFY
- K230730 — Apyx
- K230913 — ANDI
- K231275 — Exceed Biplanar Expandable Interbody System
- K231577 — MOBILETT Impact
- K231621 — Reprocessed ViewFlex Xtra ICE Catheter (D087031)
- K231878 — Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101
- K231900 — A-TAP (previously called Arthrotap)
- K231924 — EZ-IO Intraosseous Vascular Access System
Data sourced from openFDA. This site is unofficial and independent of the FDA.