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
3577–3600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 2025
Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q
K250573 · ODD
Olympus Medical Systems Corp.
Gastroenterology & Urology · 90d
Cleared May 27, 2025
Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)
K250475 · ITI
Ningbo Baichen Medical Devices Co., Ltd.
Physical Medicine · 97d
Cleared May 27, 2025
Dexter L6 System
K250435 · SDD
Distalmotion SA
General & Plastic Surgery · 102d
Cleared May 27, 2025
Rennou™ Varnish (3% / Spearmint)
K243777 · LBH
Theodent, LLC
Dental · 169d
Cleared May 27, 2025
Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)
K242841 · GXI
Abbott Medical
Neurology · 250d
Cleared May 27, 2025
Puritan PurSafe Plus Collection and Transport System
K242820 · QBD
Puritan Medical Products, LLC
Microbiology · 251d
Cleared May 27, 2025
Integral Dental Units
K242611 · EIA
Mipont Medical Equipment Co., Ltd.
Dental · 266d
Cleared May 27, 2025
Helios+ UV-C System
K242604 · QXJ
Preventamed Technologies, Inc. Dba...
General Hospital · 270d
Cleared May 23, 2025
RECLAIM Monobloc Revision Femoral Stem
K251292 · LZO
Depuy Ireland UC
Orthopedic · 28d
Cleared May 23, 2025
ViewFlex™ Xtra ICE Catheter
K251211 · OBJ
Abbott Medical
Cardiovascular · 35d
Cleared May 23, 2025
93 NeuFlex Catheter
K251044 · QJP
Piraeus Medical
Neurology · 50d
Cleared May 23, 2025
Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01...
K250938 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 56d
Cleared May 23, 2025
Sil-Flow
K250778 · EBF
Dsi Dental Solutions, Ltd.
Dental · 70d
Cleared May 23, 2025
Optilite® Freelite Mx Kappa Free Kit
K250549 · DFH
The Binding Site Group , Ltd.
Immunology · 87d
Cleared May 23, 2025
Knotilus+ Biocomposite Knotless Anchor
K250544 · MAI
Stryker Endoscopy
Orthopedic · 87d
Cleared May 23, 2025
Frida™ Anterior Cervical Plate System
K250446 · KWQ
Spineup, Inc.
Orthopedic · 98d
Cleared May 23, 2025
IPL400
K250384 · OHT
El Global Trade, Ltd.
General & Plastic Surgery · 101d
Cleared May 23, 2025
SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1
K250361 · NFO
Geske Beauty Tech GmbH
Neurology · 102d
Cleared May 23, 2025
NeuroMatch
K250239 · OLX
LVIS Corporation
Neurology · 116d
Cleared May 23, 2025
Clever One
K250005 · QIH
Ewoosoft Co., Ltd.
Radiology · 141d
Cleared May 23, 2025
Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
K244047 · JKA
Venocare, Inc.
General Hospital · 143d
Cleared May 23, 2025
Second Opinion® 3D
K243989 · QIH
Pearl, Inc.
Radiology · 148d
Cleared May 23, 2025
Accuro 3S
K243937 · IYO
Rivanna Medical, Inc.
Radiology · 154d
Cleared May 23, 2025
MagnetOs MIS
K243474 · MQV
Kuros Biosciences B.V
Orthopedic · 196d