FDA 510(k) clearances — page 134
clearances on record, most recent first.
Clearances — page 134
13,301–13,400 of 175,699- K213114 — BentrioTM Allergy Blocker
- K213250 — Secret Duo
- K213439 — FlexBoardTM, EagleBoardTM, BreastBoard SXTM
- K213789 — Intelligence LaserComb
- K214123 — T-FIX® 3DSI Joint Fusion System
- K220300 — OTOPLAN
- K220377 — Procedure Mask
- K220575 — MAGNETOM Free.Max, MAGNETOM Free.Star
- K220801 — ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
- K220942 — 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)
- K221524 — Sugita AVM Microclip Applier
- K221834 — Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
- K201788 — EDEN Spinal Fixation System
- K211173 — maxmorespine Bipolar Electrodes
- K213194 — HD Mediastinoscope
- K213233 — EZYPRO ECG Recorder (Model: UG02)
- K213338 — CORE-CLIP
- K213349 — Catalyst R1 Reverse Shoulder System
- K213612 — SYLFIRM X
- K220494 — BreathID Hp Lab System, BreathID Smart System
- K220497 — CoLumbo
- K220514 — bite away neo
- K220732 — Mural Perinatal Surveillance
- K220756 — Introcan Safety 2 IV Catheter
- K220993 — Ultrasound System SONIMAGE MX1
- K221188 — ZEPTO Precision Capsulotomy System
- K221204 — Excipio SV Thrombectomy Device
- K221511 — Axial3D Cloud Segmentation Service
- K211877 — Klassic Knee System
- K212665 — Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)
- K213230 — T3 Platform Software
- K213274 — Qlicksmart BladeFlask UNIVERSAL
- K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
- K213345 — Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
- K213682 — HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote
- K213739 — Nitrile Examination Gloves
- K213765 — Glidewell 3DP Denture Base Resin
- K220413 — Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
- K220586 — Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
- K221008 — HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
- K221185 — TC Gloves
- K221192 — Disposable Nitrile Powder-Free Examination Gloves
- K221482 — Esophageal TTS Stent
- K203791 — Stainless Turbine
- K210766 — AcQMap 3D Imaging and Mapping Catheter, Model 900009
- K211148 — CORE-Trocar
- K211979 — Lumenis Y&R Laser System
- K213220 — Revaree Plus Vaginal Suppositories
- K213665 — Syngo Carbon Space VA20A
- K220270 — Aspirex Thrombectomy System
- K220478 — NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System
- K220482 — Sherlock
- K220800 — Venue Go
- K220856 — Vial Adapter Ø13mm
- K213228 — NeuroLine Disposable Cranial Perforator with Hudson end
- DEN210004 — Zuno Smart Sterilization Container
- K211099 — Freezen Clear Skin Clinic Warts & Tags
- K212871 — Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
- K213037 — IDx-DR v2.3
- K213197 — MyOnyx System
- K213255 — CipherOx CRI Tablet
- K220210 — Disposable Endoscopy Adapter Set
- K220431 — Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
- K220523 — restor3d TiDAL Lumbar Interbody Fusion Device
- K220572 — Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
- K220813 — ART-PLAN
- K221117 — RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
- K221217 — SPY Laparoscope
- K221408 — ARIA Radiation Therapy Management (v16.1 MR3)
- K221463 — ElucidVivo A.3
- K221465 — Baby Gorilla/Gorilla Plating System
- K221470 — Langston dual lumen catheter
- K201037 — FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
- K201348 — DePuy 3D Additive TriFlange Acetabular Cup
- K203624 — Custom-made Invisible Aligners
- K212426 — Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])
- K212788 — Seer Home
- K212870 — TLC Unicompartmental Knee System
- K213504 — Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
- K220299 — Ion Endoluminal System (IF1000)
- K220399 — WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
- K220440 — Dentis s-Clean Abutment Mini
- K220469 — Disposable Vinyl Examination Glove
- K220878 — Straumann TLX Variobase C
- K221186 — TC Gloves
- K221226 — 1st Glove Blue Nitrile Examination Gloves Powder Free
- K221345 — Wireless Digital Flat Panel Detector
- K212325 — EEG-acp
- K213088 — ZQuiet Advance
- K213626 — VITROS AFP
- K213684 — SurgiCase Viewer
- K220106 — QardioArm 2
- K220614 — MEDOJECT fine Pen Needles
- K220804 — Dia-X Bond Universal
- K221448 — ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)
- K211466 — Yomi Robotic System with YomiPlan Go
- K212808 — Logic Hd camera head green, System green
- K213467 — EVA NEXUS Ophthalmic Surgical System
- K220004 — Zsquare ENT-Flex Endoscope
- K220550 — Disposable Surgical Face Mask (M663BE, M663BT)
Data sourced from openFDA. This site is unofficial and independent of the FDA.