FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
6121–6144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2024
Sphere-9Dx Diagnostic Catheter (AFR-00009)
K233433 · MTD
Medtronic
Cardiovascular · 300d
Cleared Aug 07, 2024
Liposaver
K212969 · QPB
Lhbiomed Co., Ltd.
General & Plastic Surgery · 1056d
Cleared Aug 06, 2024
Abiomed 14Fr Low Profile Introducer Kit
K241708 · DYB
Abiomed, Inc.
Cardiovascular · 54d
Cleared Aug 06, 2024
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis...
K241528 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 68d
Cleared Aug 06, 2024
myAblation Guide (VB80A)
K240796 · QTZ
Siemens Healthcare GmbH
Radiology · 137d
Cleared Aug 06, 2024
EOSedge
K233920 · KPR
Eos Imaging
Radiology · 237d
Cleared Aug 05, 2024
da Vinci E-200 Electrosurgical Generator
K241635 · GEI
Intuitive Surgical
General & Plastic Surgery · 60d
Cleared Aug 05, 2024
Universal Seal (5-12 mm)
K241360 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 83d
Cleared Aug 05, 2024
AI Platform 2.0 (AIP002)
K240953 · QIH
Exo Imaging
Radiology · 119d
Cleared Aug 05, 2024
HybridTherm System
K240932 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 122d
Cleared Aug 05, 2024
CellFX Percutaneous Electrode System (SYS3000)
K240782 · GEI
Pulse Biosciences, Inc.
General & Plastic Surgery · 137d
Cleared Aug 05, 2024
PlumeSafe X5 Smoke Management System
K240127 · FYD
Conmed Corporation
General Hospital · 201d
Cleared Aug 05, 2024
Precision AI Surgical Planning System (PAI-SPS)
K233992 · QHE
Precision AI Pty, Ltd.
Orthopedic · 231d
Cleared Aug 05, 2024
Orthopaedic Surgery Planning Software (AIJOINT)
K233761 · LLZ
Longwood Valley Medical , Ltd.
Radiology · 255d
Cleared Aug 05, 2024
Midfield Light Pipe, 23ga (3269.M06-00)
K233653 · MPA
Peregrine Surgical, LLC
Ophthalmic · 265d
Cleared Aug 05, 2024
Sleepio®
K233577 · QVO
Big Health, Inc.
Neurology · 272d
Cleared Aug 02, 2024
Coronis OneLook
K242008 · PGY
Barco N.V.
Radiology · 23d
Cleared Aug 02, 2024
Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101)
K241987 · HIH
Guangzhou Red Pine Medical Instrument...
Obstetrics & Gynecology · 25d
Cleared Aug 02, 2024
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K241970 · LZA
Kanglongda Vietnam Protection...
General Hospital · 28d
Cleared Aug 02, 2024
Innovita HCG Pregnancy Rapid Combo Test
K241919 · JHI
Innovita (Tangshan) Biological...
Chemistry · 32d
Cleared Aug 02, 2024
MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander
K241918 · LCJ
Mentor Worldwide, LLC
General & Plastic Surgery · 32d
Cleared Aug 02, 2024
Cortera™ Spinal Fixation System
K241892 · NKB
Xtant Medical Holdings, Inc.
Orthopedic · 35d
Cleared Aug 02, 2024
Global Modular Replacement System, Modular Replacement System, Modular...
K241716 · JDI
Howmedica Osteonics Corp., Dba...
Orthopedic · 49d
Cleared Aug 02, 2024
Diode Laser Hair Removal System (MBT-Diode Laser)
K241642 · GEX
Beijing Mega Beauty Technology Co., Ltd.
General & Plastic Surgery · 56d