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
7825–7848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2024
GI Genius™ Module 100 (GGM100.US)
K233964 · QNP
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 28d
Cleared Jan 12, 2024
Meridian Interbody System
K233694 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 56d
Cleared Jan 12, 2024
Biograph VK10
K233677 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Jan 12, 2024
Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use...
K233520 · LZA
Anhui Powerguard Technology Co., Ltd.
General Hospital · 72d
Cleared Jan 12, 2024
Cypris eXact Suturing System
K233355 · GAW
Cypris Medical
General & Plastic Surgery · 105d
Cleared Jan 12, 2024
ClearPointer Optical Navigation Wand
K233155 · HAW
ClearPoint Neuro, Inc.
Neurology · 107d
Cleared Jan 12, 2024
ClearPoint Bone Screw Fiducials
K233144 · HAW
ClearPoint Neuro, Inc.
Neurology · 107d
Cleared Jan 12, 2024
SmartFrame OR
K233141 · HAW
ClearPoint Neuro, Inc.
Neurology · 107d
Cleared Jan 12, 2024
Zirconia Block
K233125 · EIH
Hangzhou Ivista Medical Devices Co.,...
Dental · 107d
Cleared Jan 12, 2024
LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)
K233114 · OHS
Shenzhen Idea Light Limited
General & Plastic Surgery · 107d
Cleared Jan 12, 2024
Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask...
K233022 · MSH
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 112d
Cleared Jan 12, 2024
TauTona Pneumoperitoneum Assist Device (TPAD)
K233020 · HIF
Tautona Group Research & Development,...
Obstetrics & Gynecology · 112d
Cleared Jan 12, 2024
A’TOMIC™ Nitinol Fixation System
K232990 · JDR
Rmr Ortho, LLC
Orthopedic · 112d
Cleared Jan 12, 2024
Hem-o-lok® Ligating Clips
K232970 · FZP
Teleflex Medical
General & Plastic Surgery · 113d
Cleared Jan 12, 2024
LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape))
K232615 · NEU
Devicor Medical Products, Inc.
General & Plastic Surgery · 137d
Cleared Jan 12, 2024
Ti Link Abutment
K232170 · NHA
Izenimplant Co., Ltd.
Dental · 175d
Cleared Jan 12, 2024
PROBEAT-FR
K232032 · LHN
Hitachi, Ltd. Radiation Oncology...
Radiology · 189d
Cleared Jan 12, 2024
PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single...
K231970 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 193d
Cleared Jan 12, 2024
SoloSmart Injection Pen Adapter (SoloSmart®)
K231820 · QOG
Biocorp Production
General Hospital · 205d
Cleared Jan 12, 2024
Quick - Radius Disposable Set
K231684 · HRS
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 217d
Cleared Jan 12, 2024
SMB Luer lock disposable syringe
K231558 · FMF
Smb Corporation of India
General Hospital · 227d
Cleared Jan 12, 2024
BEE Cervical Cage
K231371 · ODP
NGMedical GmbH
Orthopedic · 245d
Cleared Jan 12, 2024
Velox Power Chair
K231315 · ITI
Velox Manufacturing, Inc.
Physical Medicine · 252d
Cleared Jan 12, 2024
MD Mattress Suture Placement Device
K222783 · GCJ
Lsi Solutions, Inc.
General & Plastic Surgery · 484d