FDA 510(k) clearances — page 116
clearances on record, most recent first.
Clearances — page 116
11,501–11,600 of 176,479- K222350 — Sterile Nitrile Surgical Gloves Powder Free
- K222738 — Point implant system
- K223435 — FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System
- K223879 — Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
- K230010 — ADSEAL Plus
- K230098 — Trusana
- K230143 — DESS Dental Smart Solutions
- K230264 — Ezra Flash
- K230387 — ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C) +4 more
- K230393 — UniCam Evo Software
- K230412 — Symmed Elite Aesthetic
- K230694 — NaviCam Xpress Stomach System, NaviCam Xpress System
- K230719 — BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
- K230868 — SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control
- K220312 — Polyfusion IV Administration Sets
- K223332 — Task Force CORE
- K223838 — Catalys Precision Laser System
- K230424 — Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System
- K221303 — Neuspera Nuity System
- K222781 — Augmento
- K222910 — Bronchoscope System
- K223530 — Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
- K223763 — ZeptoLink IOL Positioning System
- K223830 — Ultrasound System 2300
- K230402 — ENROUTE® Transcarotid Neuroprotection System
- K230705 — POT PTCA Balloon Dilatation Catheter
- K230732 — Eagle S/Saevo Slim/D700 Slim
- K230753 — RCT800
- K230754 — L12 LED Light Source with AIM
- DEN220033 — MISHA Knee System
- K222887 — Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor
- K223176 — Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire, Cleaner Plus Handpiece with 135cm Maceration Wire, Cleaner Plus Aspiration Canister
- K223550 — DMX
- K230122 — IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
- K230164 — TENS and EMS Stimulation (OTC)
- K230360 — IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
- K230366 — Arthrex Univers Revers Monoblock Stem Size 4/33
- K230695 — APRO 70 Catheter and Alembic Aspiration Tubing
- K230699 — ARIA Radiation Therapy Management (v18.0)
- DEN210055 — The N-SWEAT Patch
- K220456 — Elecsys FT4 IV
- K222909 — Axiostat Gauze
- K223052 — Peri-Guard and Supple Peri-Guard
- K223088 — BD SmartSite Needle-Free Connector
- K223373 — Enivo
- K223640 — Axoguard HA+ Nerve Protector (5 models)
- K223772 — PRO Plating System, Stryker Trauma Pelvic Set (Matta)
- K223816 — Dental CT Scanner AXR
- K230064 — Mazor X System (Mazor X Stealth Edition)
- K230318 — Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo 4D Semirigid Annuloplasty Ring
- K230575 — Limbus Contour
- K230658 — SKOUT® system
- K222023 — RayFlow
- K222197 — F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
- K222360 — AI-Rad Companion (Cardiovascular)
- K222739 — Disposable Insulin Pen Needle
- K223458 — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
- K223531 — CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)
- K223774 — Contour ProtégéAI
- K230069 — S.I.N. Dental Implant System
- K230097 — IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
- K230169 — EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert
- K230313 — QUANTUM Patient Specific Instrumentation (PSI) System
- K230341 — ACRIFIX
- K230640 — Affinity Fusion Oxygenator System
- K211556 — N2
- K214009 — D·Kaptain PTA High Pressure Balloon Dilatation Catheter
- K221118 — CO2 Mainstream Sensor
- K221493 — MicroScan Prompt Inoculation System-D
- K221537 — Nightwear Aligners
- K222012 — FAQ 101
- K222677 — Intermittent nelaton catheter for single use
- K223256 — Optimos Cystotome
- K223310 — Antimicrobial Silicone PHMB Foam Wound Dressing
- K223630 — Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
- K230033 — Da Vinci SP Surgical System (SP1098)
- K230035 — BioSci Disposable Virus Sampling Tubes
- K230107 — Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588
- K230336 — CurrentBody Skin Led Hair Regrowth(Model: MZ-07)
- K230689 — T-FIX 3DSI Joint Fusion System
- K213584 — Reprocessed NRG Transseptal Needle
- K220142 — BRM Digitalis Spacer
- K230029 — NeuroStar Advanced Therapy System (Version 3.7)
- K230385 — Ballancer Platinum (1222)
- K213749 — G7, Dental Operative Unit and Accessories
- K220454 — Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application
- K221802 — iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
- K222006 — Sclerotherapy & Endoscopic Needles
- K222865 — M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle
- K223240 — Annalise Enterprise CTB Triage Trauma
- K230028 — Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
- K222370 — SpO2 Extension Cable
- K221734 — Maxtec MaxO2 ME+p
- K230568 — FiberTak Suture Anchor
- DEN200011 — Masimo SafetyNet
- K211059 — CereFlow V1.2
- K213272 — Formus Hip
- K213660 — RadAlly
- K220068 — Butterfly iQ/iQ+ Ultrasound System
- K220780 — ROVO Mechanical Thrombectomy Device
Data sourced from openFDA. This site is unofficial and independent of the FDA.