FDA 510(k) clearances — page 46
clearances on record, most recent first.
Clearances — page 46
4,501–4,600 of 176,479- 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) +12 more
- 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 (5 models)
- K251452 — Celerity 5 HP Biological Indicator (LCB052) +3 more
- 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 (8 models)
- 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
- K250001 — Patriot SI Implant System
- K250529 — Globe Introducer (601-01001)
- K250598 — Endoform Reconstructive Template - PLGA
- K250657 — gi2000 Electrosurgical Generator
- K250682 — BD Nexiva Diffusics Closed IV Catheter System and BD Nexiva Diffusics Closed IV Catheter System with BD MaxZero Needle-free Connector
- K251035 — DISINTEK PA Test Strips
- K251127 — PENTAX Medical Video Processor (EPK-i8020c)
- K250410 — GORE® Tri-Lobe Balloon Catheter
- K250452 — CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)
- K250844 — PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop
- K250965 — Automated Blood Coagulation Analyzer CN-Series (CN-6000)
- K251335 — Tera Lumbar Interbody Fusion System (Various PNs)
- K251376 — LimFlow ARC
- DEN240047 — Allix5
- K241313 — OHC COVID-19 Antigen Self Test
- K242635 — Endoscopic Distal Attachment (AF-D series)
- K242640 — FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
- K242725 — Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
- K242751 — ARIX Pectus Bar System
- K242830 — LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
- K242926 — XBody Go USA, XBody Pro USA
- K243005 — AudaxCeph Cephalogram Analysis Software
- K243010 — Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804) +5 more
- K243505 — 5008X Hemodialysis System
- K243522 — ViVi® Toga Premium
- K243530 — Dynamic TiBase
- K243654 — DentalJect
- K243863 — Opulus Lymphoma Precision
- K250024 — TE Air Diagnostic Ultrasound System
- K250078 — Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
- K250150 — VANGUARD Blood cardioplegia Systems (3 models)
- K250195 — MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
- K250236 — Swoop® Portable MR Imaging® System (V2)
- K250317 — EsFlow PLUS
- K250365 — Motif Aura Glow breast pump (Model Motif Aura Glow)
- K250368 — Wearable Breast Pump (Model S21)
- K250581 — KALA Red Light Face Mask (KALA-01)
- K250637 — VCFix Spinal System
- K250957 — Disposable Biopsy Forceps (4 models)
- K251063 — TekBrace Solo Soft Tissue Reinforcement Device
- K251238 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000) +2 more
Data sourced from openFDA. This site is unofficial and independent of the FDA.