FDA 510(k) clearances — page 40
clearances on record, most recent first.
Clearances — page 40
3,901–4,000 of 176,479- K251033 — Unscented menstrual long applicator tampon +3 more
- 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) +1 more
- 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) +3 more
- 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) +6 more
- 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) +1 more
- 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 +11 more
- 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
- K252239 — InVision 3T Recharge Operating Suite
- K252326 — InterSpace GV Hip Spacer
- K244016 — iPETcertum (v1.0)
- K250246 — uMR Jupiter
- K250434 — trophon2
- K250934 — Respiree Cardio- Respiratory Monitor System
- K251411 — Chemfort Female Luer Lock Adaptor
- K252113 — PRADO Lumbar Interbody Fusion System
- K252141 — AltiVate Reverse® Glenoid
- K250950 — CUTIVA Topical Skin Adhesive (RM1700); CUTIVA PLUS Skin Closure System (RM1739)
- K251087 — Blood Volume Analyzer (200)
- K251113 — iHealth Compare Wireless Blood Pressure Monitor(BP-300C) +9 more
- K251122 — Terragene® Bionova® BT20 Biological Indicator
- K251223 — HnX-P1, HnX-PB
- K251762 — Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG)
- K243427 — QuickSleeper 5
- K243448 — Equinoxe® Shoulder System
- K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more
- K243462 — Diazyme Colorimetric Lithium Assay
- K243483 — Access hsTnI
- K243496 — MycoMEIA Aspergillus Assay
- K243841 — Sparta Infusion Set for Insulin
- K250315 — RONAVIS FX (FX-001)
- K250381 — Deepsight NeedleVue LC1 Ultrasound System
- K250495 — MINI VP1 (PL67_F); MINI VP1 (PL61_F)
- K250508 — AK 98 Dialysis Machine (955607)
- K250541 — Self-Forming Magnet (Flexagon Plus OTOLoc)
- K250790 — INNOVISION-DXII
- K250941 — Revolution Vibe
- K251252 — NOBILCAM IMPAK Disc
- K251652 — Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo
- K251707 — IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)
- K252094 — eZSURE Empty Fluid Container
- DEN240068 — ArteraAI Prostate
- K241461 — Mpact Constrained Liner
- K242728 — BeneVision Central Monitoring System
- K243341 — Genius AI Detection 2.0
- K243455 — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
- K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
- K243656 — U2 Total Knee System PF+ Patella; USTAR II System PF+ Patella
- K244060 — eCO2 3D
Data sourced from openFDA. This site is unofficial and independent of the FDA.