FDA 510(k) clearances — page 60
clearances on record, most recent first.
Clearances — page 60
5,901–6,000 of 176,479- K243224 — MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)
- K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S) +2 more
- K243670 — Idys® LIF
- K242376 — Next Generation Access Platform
- K242804 — PAL Aspiration System
- K243394 — AF531 Oro-Nasal SE Face Mask
- K243445 — Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
- K233119 — 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
- K240828 — OEC One ASD
- K241127 — INNO SLA Mini Plus® Implant System
- K241924 — Elastic Impression Material
- K241972 — BLUEDIAMOND IMPLANT
- K242252 — Power Wheelchair
- K242480 — FLASH EVD System (10-0002)
- K243084 — BioTraceIO Precision (2.0)
- K243835 — TiLink-P SI Joint Fusion System
- K232966 — FISIOWARM 7.0
- K233252 — Straumann CARES Visual and Nova Dental CAD
- K240517 — ProSeal Vented Universal Vial Adaptor
- K243037 — Diode Laser System model Dawn-S
- K243097 — RM STAR EX with RMS Needle
- K243141 — Diode Laser System (5 models)
- K243658 — TMC Compression Implant System
- K243677 — iovera° System
- K242434 — Insulin Syringes
- K243623 — SpineAR SNAP (SyncAR Spine)
- K233614 — Genadyne DUO NPWT
- K240890 — PanopticAI Vital Signs
- K240975 — Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)
- K241091 — SIMEOX 200 Airway Clearance Device
- K241288 — Noxturnal Web
- K241856 — Sofjec (3 models)
- K242091 — Bolo Button System
- K242143 — Angiography Injector
- K242403 — Aquilion ONE (TSX-308A/3) V1.5
- K242573 — NIDO Baby Magnetic Resonance Imaging System
- K242735 — Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min) +1 more
- K242782 — GlassBone Granules
- K242797 — OsteoFlo HydroFiber
- K242939 — ARTFX Trauma Bone Plate and Screw System
- K242948 — Adora DRFi (04550010)
- K243103 — Denture Base
- K243177 — SACS PRO
- K243248 — INHANCE INTACT
- K243693 — NEO Pedicle Screw System
- K243121 — SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA +48 more
- K243085 — IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)
- K243147 — LGO-Surgical Laser Fibers
- K233639 — SmartClip Secure Soft Tissue Marker
- K240435 — Alpha Dent Implants Dental Implants System
- K241167 — BioSphere Putty; BioSphere MIS Putty
- K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip
- K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)
- K241652 — DASH® SARS-CoV-2 & Flu A/B Test
- K241670 — Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)
- K241680 — Momcozy Wearable Breast Pump (BP311)
- K241888 — Single-use Balloon Dilatation Catheter
- K242168 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K242281 — Arrow Endurance Extended Dwell Peripheral Catheter System (4 models)
- K242362 — Lightning Viewer
- K242529 — Tigon Medical All-Suture Anchors (ASA)
- K242530 — HF-Etchant Hydrofluoric Acid Etching Gel
- K242534 — HandPICO Fractional Laser Handpiece Tip
- K242572 — TopCEM-Try in Veneer Try-in Gel
- K242599 — aprevo® Digital Planning
- K242628 — Scooter (PS30)
- K242644 — SENDERO MAX Delivery Catheter
- K242688 — Finiff System
- K242923 — SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)
- K242929 — Fas Aligner System
- K242953 — KIDS Arterial Filters
- K243024 — Cellbrick Knee Spacer
- K243040 — LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)
- K243149 — Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
- K243293 — Zimmer® Persona® Personalized Knee System
- K243308 — Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
- K243607 — Moda-flx Hemodialysis System Cartridge (102121-001 )
- K243629 — Momcozy Wearable Breast Pump (5 models)
- K243671 — ExcelsiusGPS® Instruments
- K243675 — InkSpace Imaging Small Body Array
- K243759 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
- K243911 — HPR Cordless Hygiene Handpiece
- DEN240014 — ARC-EX System
- K232813 — Therapy EC, Therapy XT
- K240348 — Quantum Mitohormesis (QMT) (M2101)
- K240885 — Shadow Catheter
- K241168 — System 83 Revolve Endoscope Washer/Disinfector
- K241322 — Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010)
- K241637 — Echo Intracranial Base Catheter
- K241768 — Broadway 8 Catheter
- K241778 — Hudson RCI Comfort Flo® CubCannula
- K242063 — LibAirty Airway Clearance System
- K242270 — OrthoNext Platform System
- K242370 — Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937 (ESE103A))
- K242467 — IQ-UIP
- K242700 — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)
- K242819 — IPD Dental Implant Abutments
- K242892 — Cristaline Aligners Z FLX
- K242908 — UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD) +1 more
- K242954 — Integrity V500 (Integrity, Integrity with VEMP)
Data sourced from openFDA. This site is unofficial and independent of the FDA.