FDA 510(k) clearances — page 37
clearances on record, most recent first.
Clearances — page 37
3,601–3,700 of 175,620- K243234 — Second Opinion® CS
- K243608 — TRIGEN Stable Lock Nut & Washer
- K243683 — Deka Bluebeam
- K243973 — FIX-L PEEK PLIF and T-PLIF System
- K250559 — GMReis Fibula Nail System
- K250782 — Fractional CO2 Laser Machine
- K250789 — Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50
- K250826 — Multi M Series
- K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)
- K250936 — Q-Switched Nd:YAG Laser (SHE-LSP101-1)
- K251153 — Aurora
- K251154 — RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments
- K251193 — Grafton DBM; Grafton Plus DBM Paste; Magnifuse Bone Graft
- K251209 — Medical Monitor (32HS710S)
- K251279 — Disposable Cytology Brush BC-202D/203D Series
- K251459 — OneLIF Interbody Fusion System
- K251557 — Bard® Mesh; Bard® Mesh Pre-Shaped
- K240852 — da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
- K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
- K243482 — Self-Forming Magnet (Flexagon)
- K250269 — Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection)
- K250584 — Rezum System
- K250646 — Impact PEEK Union Nail System
- K250710 — Injectable Root Canal Bioceramic Sealer (nRoot SP)
- K250787 — Liberant Thrombectomy System
- K250933 — LORRAINE 2.5/3.5mm Distal Humerus System
- K251499 — Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)
- K242921 — 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm
- K242996 — EndyMed PRO MAX
- K243512 — FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP
- K243956 — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
- K250010 — EXTRON 3; EXTRON 5; EXTRON 7
- K250354 — Viz Subdural+, Viz SUBDURAL PLUS
- K250735 — Dental Barrier and Sleeves
- K250768 — Elecsys Anti-SARS-CoV-2
- K250465 — CO2 Laser Machine (Lume)
- K250830 — LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
- K251093 — Bonvadis®
- K251500 — MallyaG Injection Pen Adapter (MallyaG)
- K250746 — Magnetic Surgical System
- K240983 — Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
- K242431 — Omnia Medical PsiF DNA System
- K242737 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
- K242759 — Geister K-Rex rongeurs
- K242774 — SpydrBlade Flex Instrument (PRD-RG1-001)
- K242907 — DELPHI System
- K243002 — MBA Biotech Implant System
- K243456 — ONVOY Acetabular System
- K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay
- K243550 — KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
- K243694 — Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue
- K243994 — Steam Sterilizer (2545D)
- K250109 — TYBR Collagen Gel
- K250321 — GCI Sterilization Wrappers
- K250591 — Anovo Surgical System (6Ne)
- K250722 — Nd: YAG Laser Therapy System (QN-1)
- K250891 — Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C
- K251009 — Cirrus Resting State fMRI Software
- K251042 — Light Therapy System (M500, L6)
- K251131 — Annex® 2 Adjacent Level System
- K251283 — Once-Fil Flow
- K251450 — Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)
- K251452 — Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
- K251525 — SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System
- K242464 — Stealth Spine Clamps; ModuLeX Shank Mounts
- K242704 — Synchrony (20-3000)
- K242736 — Portable Oxygen Concentrator (Spirit-3)
- K242744 — Trinity EVO Acetabular Shell
- K242750 — Central Station
- K243639 — Portare System (FA-001)
- K243667 — Sonic DL
- K243703 — TechLive
- K250467 — Red Light Hair Growth Cap (LP-RJVGRW-BLK)
- K250545 — Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)
- K250616 — Clave Neutral-Displacement Needlefree Connectors
- K250701 — Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)
- K250800 — UroNav 4
- K251084 — zirkon; structure; LFU shades, stains and glazes
- K251456 — BrightHeart View Classifier
- K240788 — Ultrasound Stimulator
- K241433 — EVE Synergy (EVE-20M)
- K242712 — LubriZenzs
- K243368 — Montblanc Plate System
- K243499 — NG-Test® CTX-M MULTI
- K243810 — TraumaCad Neo (1.1)
- K243843 — Tendon Protect (50242)
- K250118 — Disposable Balloon Catheter B5-2C
- K250259 — TeleRehab Aermos Cardiopulmonary Rehabilitation
- K250749 — PhysCade System
- K250804 — ID LIGHT CURE SYSTEM
- K250879 — Paradigm System
- K250961 — Blood collection tube holders
- K251216 — 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line
- K251397 — Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System
- K251433 — Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)
- K242897 — Partial Flex
- K243205 — EVAC
- K243382 — RZ Resectoscope System
- K243796 — GLOVEONE Powder-Free Nitrile Examination Gloves Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl]
- K243948 — Raptor Aspiration Catheter; Balt Aspiration Tubing Set
Data sourced from openFDA. This site is unofficial and independent of the FDA.