FDA 510(k) clearances — page 42
clearances on record, most recent first.
Clearances — page 42
4,101–4,200 of 175,620- K250869 — Parietene Macroporous Mesh (PPM5050 )
- K250944 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl
- K241931 — OcuMet Beacon (OCUB100)
- K242247 — ARIX Femur Nail System
- K242542 — Medentika CAD/CAM Abutments
- K243343 — BD CTGCTV2
- K243386 — Ventris Intervertebral Body Fusion Device
- K243621 — Evoblock, Perléon
- K243944 — Aperta NSE PTA Balloon Dilatation Catheter
- K250669 — Adaptix Interbody System with Titan nanoLOCK Surface Technology
- K242254 — D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter
- K243383 — CHIKAI Nexus 014
- K243508 — Wearable breast pump (model S12A)
- K243651 — VersaViewer
- K243875 — Spectricept Skin and Wound Cleanser
- K250176 — DAND Dental Implant System
- K251196 — Composite Orthodontic Brackets and Buttons
- K240355 — FROG (Filter Removal of Glass)
- K240775 — PeriBeam® Pericardial Membrane
- K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System
- K241996 — ULTRA 1040
- K242170 — K-ASSAY CRP (Ver.2)
- K243013 — LIAISON PLEX Gram-Negative Blood Culture Assay
- K243734 — Wireless/ Wired X-Ray Flat Panel Detectors
- K250146 — SofWave System
- K250224 — handLITE (TN19S)
- K250459 — DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
- K250481 — Extension Feeding Set with ENFit Connectors
- K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter)
- K250842 — PADLOCK CLIP EFTR Kit (00713229)
- DEN240062 — Minder System
- K242056 — miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus
- K242129 — VitalRhythm
- K242337 — FlowGuide (FG60F); GuidionShort (GS60F)
- K242992 — RayCare (2024A SP1)
- K243337 — Dental Cone Beam Computed Tomography System
- K243459 — Ultimate rTMS for OCD (M-series)
- K243460 — Ultimate rTMS
- K243750 — SimpleStitch Suturing System
- K243878 — CLARUS (700)
- K250270 — Luja Set
- K250455 — FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
- K250499 — RELiZORB (100300/100301)
- K250829 — Lacevo Wearable Breast Pump (Model S70)
- K250889 — EXULT Knee Replacement System
- K241733 — HEBE (NP0000763)
- K242500 — LARALAB
- K242647 — MySegmenter (v2.0.0)
- K242806 — Medyssey Navigation System
- K243513 — DCM (PW-DCM)
- K243853 — Clarius Prostate AI
- K250809 — Stellar M22
- K250850 — Nanox.ARC X
- K242658 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL
- K242773 — Electro Lube NXT
- K242786 — TearCare MGX System
- K242932 — Skin Clinic Nitro Clear Wart Remover
- K243055 — Préime DermaFacial Collagen+
- K250212 — LapBox Power Tissue Containment System
- K250327 — OptaBlate Radiofrequency (RF) Generator System
- K250650 — SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
- K250803 — Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup
- K250824 — Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set
- K250833 — SwissMembrane X; SwissMembrane X Socket
- K243852 — Elfor-L
- K250094 — Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)
- K250301 — Merge Universal Viewer (MUV)
- K250402 — AVAVA Skin Treatment System
- K250802 — STERRAD® 100NX Sterilizer with ALLClear Technology (10104)
- K250823 — Any-Com Flow
- DEN240064 — CT-132
- K242098 — Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
- K242120 — OTOPLAN
- K242600 — Second Opinion Periapical Radiolucency Contours
- K242646 — Dental Implant Unit
- K242748 — Oncospace
- K242772 — AirSurgN Insufflator (10030/AirSurgN)
- K243044 — Alma Harmony
- K243260 — FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R
- K243346 — cobas liat SARS-CoV-2 v2 nucleic acid test
- K243356 — Asiga DentaBASE
- K243537 — XeliteMed VertehighFix High Viscosity Spinal Bone Cement System
- K243558 — Canvas Dx
- K243710 — Disposable ureteral access sheath
- K243857 — Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US)
- K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System
- K243898 — Chlorine Sentinel II
- K243921 — LED Curing Lights (DB686 HALO)
- K250081 — Atlantis® Abutments in Titanium
- K250416 — GBrain MRI
- K250438 — CooperSurgical Milex® Pessaries
- K250748 — KLAXON (TWIST); KLAXON (TWIST R)
- K250811 — Dental Zirconia Ceramic
- K242045 — Initia T3 Acetabular Hemispherical Shell System
- K242089 — Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)
- K242561 — Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)
- K242928 — Tesera-k SC System
- K243145 — syngo.CT LVO Detection
- K243240 — Vitrea CT VScore
- K243943 — TriMed® Compression Screws
Data sourced from openFDA. This site is unofficial and independent of the FDA.