FDA 510(k) clearances — page 23
clearances on record, most recent first.
Clearances — page 23
2,201–2,300 of 176,479- K253920 — CO2 Laser Treatment Machine (CFR3M1)
- K254245 — ZAFIRA®
- K260010 — TMINI® Miniature Robotic System
- K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
- K260682 — Bond-PR Universal Adhesive
- K251777 — MESI mTABLET SPIRO
- K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
- K252531 — Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
- K252632 — Microwave Ablation Device
- K253380 — FLNT Base and FLNT Temp
- K253593 — Clarius Ejection Fraction AI
- K253771 — Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)
- K253798 — UltraPrint-Dental Hard Splint UV
- K254054 — VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System
- K254229 — Arthrex Nano FiberTak Suture Anchor
- K260003 — KARL STORZ Mediastinoscopes and Instruments
- K251998 — Atellica CH Diazo Total Bilirubin (D_TBil)
- K252448 — AViTA Pulse Oximeter (SP61)
- K252714 — C-Lant Port
- K253535 — Ligence Heart
- K253536 — Evala Nerve Stimulator (EPNR002)
- K253695 — LigaMend
- K253778 — Allday Moisturizing Rinse
- K253797 — One-Stop
- K253828 — Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)
- K253829 — Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)
- K254249 — HKT Anatomical Locking Trauma System
- K260292 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- K251700 — Ganymede 2cm diameter (FG100300) +14 more
- K251860 — Copioumed AAMI 3 Surgical Gown
- K252166 — RIB LINK Fixation System
- K253021 — ANNE Maternal
- K253328 — GMK 3D Metal Tibial Tray Extension
- K253578 — BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax +3 more
- K253641 — Owl Night Guard
- K253764 — ENOS Software Guided External Fixation System
- K253791 — PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid
- K254017 — SWINGO-3D Lumbar Cage System
- K254182 — Aster
- K254242 — KARL STORZ ICG Imaging System with RUBINA® Lens
- K254251 — InnovexView (GC146-17, GC150-20, GC155-23)
- K254271 — CAPRI
- K260254 — Enbio PRO
- K251687 — Konig Bell Circumcision Clamp
- K251724 — Remi Impression Material
- K253472 — FIREFLY® Pedicle Screw Navigation Guide
- K253559 — Ventana A Anterior Lumbar Interbody System
- K253789 — Electric wheelchair
- K253996 — BD Surgiphor Antimicrobial Irrigation System (910110)
- K260222 — Mako Total Knee Application
- K251678 — Swift Ray 1
- K252599 — Diode Laser Therapy Systems (WLA-02)
- K253186 — HemoSphere Nano Monitor (HSNANO1)
- K253707 — Electric wheelchair (W1,W3)
- K253714 — IntraSight Plus
- K253978 — Universal Seal (5-12 mm)
- K254055 — OSSIOfiber® Suture Anchor
- K254247 — OSTEOMNI SPINAL FIXATION SYSTEM
- K254267 — NanoPress 760A-BT (760A-BT)
- K260217 — AI Platform 2.2 (AIP002)
- K260287 — SP Electrocautery Device (SP20)
- K260377 — XSense Cryoablation System with CryoProbes
- K251587 — VITA VMLC Primer
- K251661 — Mariana Minerva; Mariana Nimbus
- K251864 — Rubber Utility Catheter
- K252795 — ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit) +3 more
- K253068 — Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
- K253169 — Duet Spinal Fixation System
- K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR)
- K253244 — AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
- K253486 — SKIA-Head (Model: SKIA-ST00)
- K253531 — Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402) +1 more
- K253583 — LUX Expandable Lumbar Interbody System
- K253631 — Mobility Scooter (CL-Q3, CL-Q4)
- K253648 — Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
- K253666 — IPL Hair Removal Device (Models: T31A, T32A)
- K260043 — Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)
- K260265 — MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
- K253646 — Single Use Distal Cover MAJ-2315 (MAJ-2315)
- K251692 — Advanced Tissue Resection Device
- K251653 — SPRY TMS Therapy System (0550)
- K251890 — Disposable Ureteral Stents
- K252500 — CARA System
- K252619 — QSCHECK UISACR
- K252672 — CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)
- K252972 — CARTO 3 EP Navigation System V8.4
- K252989 — POINT Kinguide Agile Hybrid Navigation System; DRF Accessories Set
- K253445 — BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)
- K253605 — Safety Heel Lancet
- K253653 — Xpert Hemorrhagic Fever
- K253660 — KLS Martin Pure Pectus System
- K253683 — FAQ (LED Panel); FAQ (Dual LED Panel)
- K254162 — KLS Martin Ixos System
- K260181 — LF Process Indicator Tape for Steam Sterilization
- K251903 — Erchonia DPN Laser (Model# EVRL)
- K252002 — Monaco RTP System (6.3)
- K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
- K252733 — ATLAS Expandable Osteotomy Wedge System
- K252814 — Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe +3 more
- K253002 — SkinStylus SteriLock MicroSystem (MP1209SL)
Data sourced from openFDA. This site is unofficial and independent of the FDA.