FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
5689–5712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 2024
Curiteva Porous PEEK Laminoplasty System
K243137 · NQW
Curiteva, Inc.
Orthopedic · 28d
Cleared Oct 28, 2024
Sterile Lancets for Single Use
K242622 · QRK
Ningbo Caremed Medical Products Co.,...
General & Plastic Surgery · 55d
Cleared Oct 28, 2024
Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
K242350 · NKB
Spinal Alignment Solutions, Inc.
Orthopedic · 81d
Cleared Oct 28, 2024
Catalyft™ LS Expandable Interbody System
K241992 · OVD
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 112d
Cleared Oct 28, 2024
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
K241718 · OHS
Shenzhen Aozemei Technology Co., Ltd.
General & Plastic Surgery · 136d
Cleared Oct 28, 2024
ECHELON 4000 60mm Compact Stapler (EC3D60C)
K241630 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 144d
Cleared Oct 28, 2024
MetaLite DX Digital Pathology Software
K240303 · QKQ
Jellox Biotech, Inc.
Pathology · 269d
Cleared Oct 25, 2024
TumorSight Viz
K243189 · QIH
SimBioSys, Inc.
Radiology · 25d
Cleared Oct 25, 2024
Cadence Ankle PSI System
K243174 · OYK
3D Systems, Inc.
Orthopedic · 25d
Cleared Oct 25, 2024
Salto Talaris Ankle PSI System
K243173 · OYK
3D Systems, Inc.
Orthopedic · 25d
Cleared Oct 25, 2024
Xpert® SA Nasal Complete
K243070 · NQX
Cepheid
Microbiology · 28d
Cleared Oct 25, 2024
LCD Monitors C310S, G310S, C316S, G316S, C616W
K243031 · PGY
Shenzhen Beacon Display Technology...
Radiology · 28d
Cleared Oct 25, 2024
Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
K243030 · OHT
Ulike Co., Ltd.
General & Plastic Surgery · 28d
Cleared Oct 25, 2024
BKS Revision System
K242984 · JWH
Ortho Development Corp.
Orthopedic · 29d
Cleared Oct 25, 2024
Pantera Pro
K242969 · LOX
Biotronik, Inc.
Cardiovascular · 29d
Cleared Oct 25, 2024
LDS Needle
K242956 · QNS
Ocuject, LLC
General Hospital · 30d
Cleared Oct 25, 2024
Freeze Point & Private Label Versions
K242625 · GEH
Cryoconcepts LP
General & Plastic Surgery · 52d
Cleared Oct 25, 2024
LYNX Photocoagulator
K242397 · HQF
Norlase Aps
Ophthalmic · 73d
Cleared Oct 25, 2024
QIAstat-Dx Respiratory Panel Mini
K242353 · QOF
QIAGEN GmbH
Microbiology · 78d
Cleared Oct 25, 2024
Neurophet AQUA (V3.1)
K242215 · QIH
Neurophet., Inc.
Radiology · 88d
Cleared Oct 25, 2024
CORGRIP* SR NG/NI Tube Retention System
K241185 · KNT
Avanos Medical, Inc.
Gastroenterology & Urology · 179d
Cleared Oct 25, 2024
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV...
K240918 · LPL
Bruno Vision Care, LLC
Ophthalmic · 205d
Cleared Oct 25, 2024
Nitrile Powder Free Examination Gloves Biodegradable (Green)
K240269 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 268d
Cleared Oct 25, 2024
FMT Disposable and Autoclavable Temperature Probes
K240223 · FLL
Metko Medikal VE Tibbi Cihazlar Dis...
General Hospital · 273d