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
4585–4608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2025
Philips IntelliSite Pathology Solution 5.1
K243871 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 79d
Cleared Mar 06, 2025
Intra-Operative Positioning System (IOPS®)
K243842 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 83d
Cleared Mar 06, 2025
Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)
K243724 · JWH
Zimmer, Inc.
Orthopedic · 93d
Cleared Mar 06, 2025
PureLift GLOW
K243587 · NFO
Xtreem Pulse, LLC
Neurology · 106d
Cleared Mar 06, 2025
BEAR® (Bridge-Enhanced ACL Restoration) Implant
K243578 · QNI
Miach Orthopaedics, Inc.
Orthopedic · 107d
Cleared Mar 06, 2025
LVivo Seamless
K243331 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 133d
Cleared Mar 06, 2025
Sterile Water USP and Sterile 0.9% Normal Saline USP
K243001 · FRO
Laboratorios Biogalenic S.A. DE C.V.
General & Plastic Surgery · 161d
Cleared Mar 06, 2025
XCELLARISPRO TWIST microneedling device
K241790 · QAI
Dermaroller GmbH
General & Plastic Surgery · 258d
Cleared Mar 06, 2025
Versacem Acetabular Shell and Double Mobility HC Liners
K241767 · LZO
Medacta International S.A.
Orthopedic · 259d
Cleared Mar 05, 2025
TITANEX Screw Systems
K250304 · HWC
Vilex, LLC
Orthopedic · 30d
Cleared Mar 05, 2025
Mako Total Hip Application 5.0
K243751 · OLO
Mako Surgical Corp.
Orthopedic · 90d
Cleared Mar 05, 2025
CROSSLEAD 0.018inch
K242597 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 187d
Cleared Mar 05, 2025
Access Cortisol
K242190 · CGR
Beckman Coulter, Inc.
Chemistry · 223d
Cleared Mar 05, 2025
NovoSorb® MTX
K242149 · QSZ
Polynovo Biomaterials Pty, Ltd.
General & Plastic Surgery · 225d
Cleared Mar 05, 2025
Prostate MR AI (VA10A)
K241770 · QDQ
Siemens Healthcare GmbH
Radiology · 258d
Cleared Mar 05, 2025
Wellead® Hydrophilic Intermittent Catheter Ready to Use
K241734 · GBM
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 261d
Cleared Mar 04, 2025
Ceevra Reveal 3+
K243933 · QIH
Ceevra, Inc.
Radiology · 74d
Cleared Mar 04, 2025
Biolox® Delta Revision heads
K243809 · LZO
Limacorporate
Orthopedic · 83d
Cleared Mar 04, 2025
Calibrate Interbody Systems
K243461
Alphatec Spine, Inc.
Orthopedic · 116d
Cleared Mar 04, 2025
Disposable Cytology Brush (AF series)
K241679 · KTI
Alton (Shanghai) Medical Instruments...
Anesthesiology · 266d
Cleared Mar 04, 2025
iPhysio® System
K232383 · NHA
Euroteknika
Dental · 574d
Cleared Mar 03, 2025
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
K243939 · JAQ
Varian Medical Systems, Inc.
Radiology · 73d
Cleared Mar 03, 2025
HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and...
K243881 · KPS
Bracco Diagnostics, Inc.
Radiology · 75d
Cleared Mar 03, 2025
JLK-SDH
K243611 · QAS
JLK, Inc.
Radiology · 101d