FDA 510(k) clearances — page 31
clearances on record, most recent first.
Clearances — page 31
3,001–3,100 of 175,620- K243539 — Apollo TMS Therapy System
- K243604 — Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid
- K250167 — Evolution Spine Navigation Instruments
- K250271 — Neodent Implant System - Zirconia Implant System
- K251086 — PnueAira (PNCU-01)
- K251161 — ANTHEM® Fracture System
- K251913 — OsteoCentric® UnifiMI® TCS Plating System
- K243650 — Zio® monitor (DFG0001)
- K243851 — CHLOE BLAST
- K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
- K250170 — PHAROS
- K250397 — Helios Dermal Scaffold
- K250620 — KLS Martin Ixos System
- K250818 — Nerveblox
- K250867 — Dunamis Screw and Suture Locking System
- K251243 — OneRF Trigeminal Nerve Radiofrequency Probes
- K251747 — VEA Align; spineEOS
- K251834 — Persona Partial Knee
- K251871 — FEATHER 01 02 03 04 (Model:01)
- K251877 — JMS CAVEO A.V. Fistula Needle Set
- K251969 — Atlas Spine Project X Expandable Posterior Lumbar Interbody System
- K251972 — Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (OG-H180)
- K252236 — CP Relief Wand Rx - TENS/NMES
- K252259 — AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
- K243437 — mOm Essential Incubator (ME1)
- K243544 — BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
- K243600 — 3nethra neo HD FA; 3nethra neo HD
- K243905 — Stitch Cerclage Suture Tapes
- K250164 — Cassette Autoclave (ACA5)
- K250898 — Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm)
- K250916 — WinForth (LM-E470KA)
- K251012 — TRUDERMAL Pro (ZLD-390)
- K251062 — Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack
- K251176 — IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)
- K251526 — FilmArray GI Control Panel M238
- K243279 — DOLORCLAST Focused Shock Waves
- K243579 — AeroJet Ventilation Catheter
- K243653 — KARL STORZ HOPKINS Telescopes for Urology
- K250163 — T2 Alpha Femur Retrograde Nailing System
- K250841 — Electrotherapy Electrodes
- K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)
- K251033 — Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons
- K251046 — S.I.N. Dental Implant System
- K251495 — MBT Compass HT CA Software; MBT FAST Shuttle US IVD
- K251519 — RelieVRx (Pico G3)
- K251569 — Bone Screw
- K252192 — Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25)
- K252201 — HS Fiber
- K252226 — Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
- K243562 — CuffGuard
- K250294 — Straumann® RidgeFit Implants
- K250755 — DS Core Diagnosis
- K250836 — 14F Duo-Flow® Side X Side Double Lumen Catheter
- K251494 — Eko Foundation Analysis Software with Transformers (EFAST)
- K251879 — Sulopenem SPM 2 µg
- K252083 — HOTWIRE System RF Generator and Footswitch (optional accessory)
- K232456 — RW-1
- K241731 — Outlook Surgical Versa One System (8900139)
- K250207 — eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)
- K250462 — UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
- K251098 — Identity Revision Humeral Stems
- K251125 — MagVenture TMS Therapy System
- K251245 — OxyMinder Pro (10310)
- K251327 — XERF
- K251823 — UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchoscopes (EBS-500C); UE BRONCHO Single-Use Bronchoscopes (EBS-600C); UE Display (UE-M10S)
- K251862 — External Fixation Bone Distractor
- K251873 — Saige-Dx
- K252211 — Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH); Duoblade Prime (DB1P, DB1P-T, DB1P-H, DB1P-TH)
- K243254 — Parkell Pit and Fissure Sealant
- K243395 — MICOR 700 with Auto I/A
- K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
- K243972 — Plain Water-based Lubricant
- K250142 — Water-based Lubricant
- K250472 — SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
- K250540 — SABER-C System
- K250718 — swiftPro System (SWF-SPS); Swift System (SWF-SYS)
- K250817 — Coretech Compression System (Coretech RHB3003)
- K251119 — MagVenture TMS Therapy System
- K251226 — Aqua Medical RF Vapor Ablation System
- K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
- K251801 — Diode laser device (BM091)
- K252170 — OptiVu Shoulder
- K252176 — Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)
- K243021 — Longboard Revision Hip Stem
- K243765 — LuMon(TM) System
- K250309 — BTL-199
- K250622 — Succession AFN System
- K250664 — Navigo Workstation 2.3 (FPRMC00039)
- K251247 — GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)
- K251629 — UNiD Spine Analyzer
- K251667 — LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)
- K242895 — Aevumed PHANTOM Suture Anchors
- K243552 — Codman Libertís 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)
- K250124 — Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532)
- K250130 — Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532)
- K250569 — Cardiologs Holter Platform
- K251038 — Digital Radiographic Imaging Acquisition Software - DR (RiasDR)
- K251120 — Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)
- K251432 — Olo
- K251854 — SteadiSet infusion set
Data sourced from openFDA. This site is unofficial and independent of the FDA.