FDA 510(k) clearances — page 79
clearances on record, most recent first.
Clearances — page 79
7,801–7,900 of 176,479- K240394 — multiFlux 1000 (F00012408)
- K240612 — CINA-VCF
- K240912 — Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)
- K240913 — Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)
- K240969 — IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)
- K241055 — Electro Lube NXT
- K241218 — Tyber Medical Anatomical Plating System
- K241226 — Fixtemp® C&B 4:1
- K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1)
- K232505 — Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter
- K232934 — Sunsphere
- K233025 — Revolution External Plating System
- K233126 — aetherSlide
- K233674 — Freedom Wrist Arthroplasty System
- K234003 — The Circadia C200 System
- K240687 — SofWave System
- K240838 — Spectrum Spine Cervical Cage System
- K241194 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
- K241289 — SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative Control
- K232672 — EasyScreen Gastrointestinal Parasite Detection Kit
- K232741 — SmartAdjust(TM) technology
- K233166 — NET Recovery Corp/NET Device
- K233389 — EK Digital Abutments
- K233481 — AltiVate Reverse® Glenoid
- K233655 — Lingo Glucose System
- K240049 — LINK(TM) External Fixator
- K240159 — InnoVoyce VYLO
- K240784 — Temperature Sensor Probe (ABL-18TP20)
- K241190 — PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
- K241207 — SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02)
- K241235 — Arthrex TightRope II
- K223629 — SpiroSphere, SpiroSphereECG, CardioSphere
- K233076 — Laser Speckle Imaging System (RFLSI CZW)
- K233344 — Regenalase Laser System
- K240304 — Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
- K240305 — ANNE Limb
- K240410 — EVOLVE Nitric Oxide Delivery System
- K240629 — Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
- K240749 — PILLAR SA Ti Spacer System (82-XXX)
- K240874 — Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)
- K241177 — React 71 Catheter
- K231426 — 8plant Implant System
- K231939 — Renasys Edge
- K232632 — Racz Neurostat RF Generator
- K232639 — Apollo TMS Therapy System
- K232646 — Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)
- K232788 — INSPIRA ART100
- K233089 — NeoSpan® Compression Implant System
- K233111 — ALGS2 Ag Alginate Wound Dressing Rx +3 more
- K233285 — KATANA Zirconia ONE For IMPLANT
- K233386 — Monik - Disposable Endoscopic Trocar
- K233777 — PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
- K234154 — uPMR 790
- K240592 — Wolff's Law Anterior Cervical Plate System
- K240723 — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
- K240769 — LVivo IQS
- K240810 — Anti Grinding Guard
- K240827 — SET-5002
- K240864 — PacePro Wire
- K241178 — DEKA ACE Pump System
- K232602 — 3DMatrix Surgical Mesh
- K232603 — CamAPS FX
- K232642 — AirKEE T900
- K233108 — VinDr-Mammo
- K233120 — CWM-930S, FIXER DV9
- K233251 — NOxBOXi Nitric Oxide Delivery System
- K233868 — dima Print Teeth & Temp
- K240294 — Syngo Carbon Enterprise Access (VA40A)
- K240701 — Drill Guide; Drill Bit; Spine & Trauma Navigation
- K241134 — 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10)
- K241396 — uCerv Flux-C 3D Porous Titanium Cervical Interbody
- K232655 — Bonvadis®
- K232740 — Paltop Short Implants
- K233099 — Gladiator
- K233268 — Impress Angiographic Catheter
- K233819 — Fogarty Venous Thrombectomy Catheters
- K233820 — Fogarty Arterial Embolectomy Catheter with Gate Valve
- K233884 — INUMI Flex Needle
- K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
- K240199 — IntraOp Alignment System
- K240224 — Zenition 90
- K240456 — Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap
- K241014 — Biomet Kirschner Wires (K-Wires)
- K241100 — Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
- K241106 — Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)
- K241126 — OviTex PRS
- K241143 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- DEN230068 — 3M Attest eBowie-Dick Test Card 10135 3M Attest eBowie-Dick Card Holder 10135CH 3M Attest eBowie-Dick Auto-reader 1190
- K232677 — Reia pessary
- K232759 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
- K232946 — Yumizen H2500
- K233336 — 21.3 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
- K233442 — troCarWash System
- K233543 — YSIO X.pree
- K240433 — ProSeal Injection Site Extended Male Luer Lock (422140)
- K240806 — Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
- K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
- K223399 — AViTA Pulse Oximeter
- K232702 — Solo+ Tympanostomy Tube Device (TTD)
- K233341 — Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410)
Data sourced from openFDA. This site is unofficial and independent of the FDA.