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
3433–3456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2025
FUJIFILM Endoscope Model EG-840N
K243512 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 210d
Cleared Jun 10, 2025
EndyMed PRO MAX
K242996 · GEI
Endymed Medical, Ltd.
General & Plastic Surgery · 257d
Cleared Jun 10, 2025
5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed,...
K242921 · BTO
Vitaltec Corporation
Anesthesiology · 259d
Cleared Jun 09, 2025
MallyaG Injection Pen Adapter (MallyaG)
K251500 · QOG
Biocorp Production
General Hospital · 25d
Cleared Jun 09, 2025
Bonvadis®
K251093 · FRO
Oneness Biotech Co., Ltd.
General & Plastic Surgery · 60d
Cleared Jun 09, 2025
LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO,...
K250830 · OHS
Shenzhen Sungrow Led Technology Co.,...
General & Plastic Surgery · 82d
Cleared Jun 09, 2025
CO2 Laser Machine (Lume)
K250465 · GEX
Nanjing Bestview Laser S&T Co., Ltd.
General & Plastic Surgery · 111d
Cleared Jun 07, 2025
Magnetic Surgical System
K250746 · PNL
Levita Magnetics International Corp
General & Plastic Surgery · 87d
Cleared Jun 06, 2025
SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
K251525 · OUR
Si-Technology, LLC
Orthopedic · 18d
Cleared Jun 06, 2025
Celerity 5 HP Biological Indicator (LCB052)
K251452 · FRC
Steris
General Hospital · 28d
Cleared Jun 06, 2025
Baby Nasal Aspirator (BN002)
K251450 · BTA
Shenzhen Desida Technology Co., Ltd.
Ear, Nose, Throat · 28d
Cleared Jun 06, 2025
Once-Fil Flow
K251283 · EBF
Mediclus Co., Ltd.
Dental · 42d
Cleared Jun 06, 2025
Annex® 2 Adjacent Level System
K251131 · NKB
Spine Wave, Inc.
Orthopedic · 56d
Cleared Jun 06, 2025
Light Therapy System (M500, L6)
K251042 · OHS
Guangzhou Ahead Intelligent...
General & Plastic Surgery · 64d
Cleared Jun 06, 2025
Cirrus Resting State fMRI Software
K251009 · QIH
Sora Neuroscience, Inc.
Radiology · 66d
Cleared Jun 06, 2025
Cure Catheter Insertion Kit (K1)
K250891 · FCM
Convatec Limited
Gastroenterology & Urology · 73d
Cleared Jun 06, 2025
Nd: YAG Laser Therapy System (QN-1)
K250722 · GEX
Hebei JT Medical Co., Ltd.
General & Plastic Surgery · 88d
Cleared Jun 06, 2025
Anovo Surgical System (6Ne)
K250591 · QNM
Momentis Surgical , Ltd.
General & Plastic Surgery · 99d
Cleared Jun 06, 2025
GCI Sterilization Wrappers
K250321 · FRG
George Courey, Inc.
General Hospital · 122d
Cleared Jun 06, 2025
TYBR Collagen Gel
K250109 · OWY
Tybr Health
Orthopedic · 141d
Cleared Jun 06, 2025
Steam Sterilizer (2545D)
K243994 · FLE
Ningbo Ican Machines Co., Ltd.
General Hospital · 162d
Cleared Jun 06, 2025
Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract,...
K243694 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 189d
Cleared Jun 06, 2025
KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
K243550 · FGB
Karl Storz SE & CO. KG
Gastroenterology & Urology · 203d
Cleared Jun 06, 2025
LIAISON PLEX Gram-Positive Blood Culture Assay
K243490 · PAM
Luminex Corporation
Microbiology · 206d