FDA 510(k) clearances — page 24
clearances on record, most recent first.
Clearances — page 24
2,301–2,400 of 175,620- K250330 — 3mensio Workstation
- K250392 — ZAP-X Radiosurgery System (ZAP-X)
- K251532 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
- K251626 — Midmark Dental Delivery System
- K252458 — Kyphoplasty Balloon Dilatation Catheters
- K252481 — cobas CMV
- K252484 — cobas HCV
- K252671 — Electric wheelchair (NSDS-01)
- K252698 — NightGuard Aire Max
- K253448 — Sonosite MT Ultrasound System
- DEN240074 — Pulsenmore ES
- K250306 — Chex-All Sterilization Pouches and Tubes
- K250338 — MSS - Humeral reverse liners extension
- K250358 — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
- K250917 — Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
- K251041 — GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100
- K251381 — Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
- K251547 — DESS Dental Smart Solutions
- K252060 — GREEN
- K252074 — Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
- K252088 — Firebird SI Navigation System
- K252160 — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))
- K252412 — Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
- K252427 — Diode Laser Hair Removal Machine (GLD01)
- K252442 — Kii Structural Balloon Access System
- K252777 — Freedom Metaphyseal Cone Implants (Metaphyseal Cones)
- K253501 — Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);
- K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent
- K250325 — BD Alaris Pump Infusion Set
- K250337 — AiORTA - Plan
- K250632 — Arctx Cool Catheter Set
- K251531 — AIR COMPRESSION BOOTS 1018195,1018196
- K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)
- K251938 — GEN5 and GEN5+ Dental Implant System
- K252046 — Zoom System (Zoom 4S Catheter)
- K252387 — Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
- K252414 — Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
- K252430 — Freeprint® denture flex
- K252529 — Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120)
- K252607 — AllTest Urinary Tract Infection Test
- K252752 — ellacor System with Micro-Coring Technology
- K253327 — HANAROSTENT Esophagus Upper (CCC)
- K253376 — OBSIDIO Conformable Embolic (M0013972101010)
- K250316 — Meduloc Intramedullary Fracture Fixation (IFF) System
- K250618 — Medi Lift Essential Eye Mask
- K250882 — SANSA HSAT
- K251643 — Synchfix EVT
- K251772 — Navilas Laser System 577sl (156691)
- K251963 — LOGIQ E10s
- K251985 — LOGIQ E10
- K252314 — Arthrex SutureTak Suture Anchor
- K252390 — Telescope Guide Extension Catheter
- K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
- K252697 — 3D Laparoscope
- K253153 — SER Pen Carain MicroSystem (MP1209SP)
- K253232 — Seguin Annuloplasty Ring
- K253242 — LCD Monitor (C1216W, C822W, C821W)
- K253283 — Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)
- K253314 — Freedom Infinia Total Knee System
- K253323 — Protrieve Sheath
- K253345 — JARVIS Diaphyseal Stem Standard
- K253355 — Difiney Advanced Anti Snoring Device 4.0
- K250275 — PrecisePath Radiofrequency Puncture Generator and PrecisePath Footswitch
- K251466 — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr
- K252165 — ZIRCONOMER P
- K252351 — UniSpace® TPLIF Cage
- K252376 — Yomi S Robotic System
- K252547 — TheraSphere 360 Y-90 Management Platform
- K252742 — Navigated Instruments
- K253300 — Fine Osteotomy
- K253399 — Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter
- K250297 — TECHFIT Patient-Specific Cranial System
- K250520 — OsteoCentric Navigated Instruments System
- K251027 — cvi42 Coronary Plaque Software Application
- K251331 — Blood Pressure Monitor (B73, BE23T)
- K251824 — Patriot Duo
- K251875 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
- K252053 — VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)
- K252467 — Disposable Vinyl Examination Gloves
- K252629 — Electric Breast Pump (HL-3058, F5112)
- K252630 — Electric Breast Pump (HL-3060, F5113)
- K250345 — Medline Bag Decanter
- K250687 — Cocoon Solo (DX-7020s)
- K250696 — AccuCheck
- K250904 — Atalante X
- K251059 — Syngo Carbon Clinicals (VA41)
- K251312 — Vesalio Peripheral System
- K251372 — VersaD Delivery Catheter
- K251710 — Mobile X-ray unit (!M1)
- K251784 — Hushd Pro Z-Link
- K251827 — Azurion R3.1
- K251974 — Arctic Sun Temperature Management System (Model 5000)
- K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components
- K252238 — CoroFlow Cardiovascular System
- K252357 — Glucose2
- K252645 — LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
- K252646 — Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)
- K252730 — Fule Spinal Fixation System
- K253106 — AngioVac Cannula
Data sourced from openFDA. This site is unofficial and independent of the FDA.