FDA 510(k) clearances — page 70
clearances on record, most recent first.
Clearances — page 70
6,901–7,000 of 175,620- K240603 — Ti-Base & Master Fix
- K240648 — Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE)
- K241262 — Baby Gorilla/Gorilla Plating System; Monster Screw System
- K232773 — da Vinci SP Surgical System (SP1098)
- K232820 — HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
- K233971 — Arthrex AlloSync PushLock Suture Anchor
- K234032 — Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line
- K240100 — SAM Model 9-10000
- K240222 — Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)
- K240463 — Slow Wave DS8 (SWDS802)
- K240505 — Eminent Spine SI Screw System
- K240627 — LIAISON PLEX Yeast Blood Culture Assay
- K240877 — Monteris Medical NeuroBlate System
- K241258 — Ingenix Spinal System
- K231291 — Perforated Baskets
- K233587 — LOCATOR Angled Abutment (Various)
- K233751 — Milieve (YPS-301BD)
- K240251 — ANNE Chest
- K240598 — Maestro System (REF100)
- K240617 — Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
- K240834 — EcoFit® short stem cementless cpTi
- K240947 — TENSOR® Suture Button System
- K241259 — Amplatz Goose Neck Snare Kit
- K220062 — QIAstat-Dx Gastrointestinal Panel 2
- K222196 — Deep TMS System
- K223427 — Mimics Enlight CMF
- K231151 — Kenota 1 Total IgE; Kenota 1 (instrument)
- K232080 — Puracyn® Plus Antimicrobial Irrigation Solution
- K232107 — °M Warmer System
- K232333 — Anti-bacterial bandage
- K232601 — BroncTru Transbronchial Access Tool
- K232715 — Distinct® Digital Pregnancy Test
- K232738 — BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)
- K232821 — S.I.N. Dental Implant System
- K232943 — Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe
- K233295 — LFR-260
- K233591 — Stylus
- K233729 — Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58
- K233842 — iHealth COVID-19 Antigen Rapid Test
- K240254 — Blood Pressure Monitor (TMB-2296-BT)
- K240281 — Bone Suppression Software
- 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; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.