FDA 510(k) clearances — page 51
clearances on record, most recent first.
Clearances — page 51
5,001–5,100 of 175,620- K241808 — ApolloHipX (THR.SS.0001)
- K242019 — GXR-Series Diagnostic X-Ray System
- K242588 — COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)
- K243259 — MASADA Modular Spinal Fixation System
- K243335 — Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
- K241904 — DermiSphere Dermal Template
- K242123 — Brainomix 360 e-CTA
- K242139 — Mobility Scooter (YL-09B, YL-07)
- K242488 — Soteria E-View
- K242499 — Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
- K242753 — SD TL Implant System
- K242760 — WHILL Model R
- K243466 — Conformity Stem Extension Line, #0
- K243481 — TMINI Miniature Robotic System
- K233118 — DUET-V (Model: ESK-3261DV)
- K233419 — GBR System
- K240346 — NobelProcera Zirconia Implant Bridge
- K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System
- K241283 — Elemental Granulate
- K241350 — Clarify DL
- K241757 — syngo.CT Dual Energy
- K242110 — PENTAX Medical Video Colonoscope (EC38-i20cWL)
- K242119 — INNOVISION-EXII
- K242578 — EVOLVE Nitric Oxide Delivery System
- K242726 — Synapsys VHIT
- K243363 — JLK-ICH
- K243737 — Inbella RF System
- K250015 — Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive
- K241005 — Haemostasis Clips
- K241388 — Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter
- K241568 — CrystLCare PRO Biorestorative, Fluoride-Plus
- K241696 — Ortho AI
- K242326 — Wave Electrode (AE02-60); Wave Electrode (AE02-50)
- K242334 — Ezra Flash
- K242448 — Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)
- K242789 — Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)
- K243049 — Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)
- K241338 — Peak Flow Meter
- K241852 — Nasal Aspirator (NS 13)
- K242468 — Power Wheelchair (D10, D12, D15, D17, D20, D37)
- K242989 — Electric Wheelchair (MODEL H)
- K243224 — MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801)
- K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
- 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 (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)
- 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 (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)
- 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); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)
- 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; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5;
- 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 (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)
Data sourced from openFDA. This site is unofficial and independent of the FDA.