FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
24505–24528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2018
Neurostructures Cavetto® [MAX] Cervical Cage System
K181590 · ODP
Neurostructures, Inc.
Orthopedic · 143d
Cleared Nov 08, 2018
VAMP Plus Venous/Arterial Blood Management Protection System
K181684 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 135d
Cleared Nov 08, 2018
CardioInsight Cardiac Mapping System
K181918 · DQK
Medtronic, Inc.
Cardiovascular · 113d
Cleared Nov 08, 2018
Faros Mobile
K182030 · MLO
Bittium Biosignals , Ltd.
Cardiovascular · 101d
Cleared Nov 08, 2018
Wrist Blood Pressure Monitor Model BP4350
K182166 · DXN
Omron Healthcare, Inc.
Cardiovascular · 90d
Cleared Nov 08, 2018
SureCure Orthodontic Aligner System
K182329 · NXC
Digital Orthodontic Care
Dental · 72d
Cleared Nov 08, 2018
Exactech Alteon Highly Polished Femoral Stem
K182462 · LZO
Exactech, Inc.
Orthopedic · 59d
Cleared Nov 08, 2018
Cepheid Xpert GBS LB Control Panel
K182472 · PMN
Microbiologics, Inc.
Microbiology · 59d
Cleared Nov 08, 2018
Geistlich Derma-Gide
K182838 · KGN
Geistlich Pharma AG
General & Plastic Surgery · 30d
Cleared Nov 07, 2018
uWS-MR
K172999 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 406d
Cleared Nov 07, 2018
uWS-CT
K173001 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 406d
Cleared Nov 07, 2018
Powder Free Vinyl Patient Examination Gloves
K180381 · LYZ
Shanxi Hongjin Plastic Technology...
General Hospital · 268d
Cleared Nov 07, 2018
Certa Dose Pediatric Midazolam 5mg/mL IM Syringe
K180683 · PQX
Certa Dose, Inc.
General Hospital · 237d
Cleared Nov 07, 2018
OptiBond eXTRa Universal
K182162 · KLE
Kerr Corporation
Dental · 89d
Cleared Nov 07, 2018
Curbell branded Patient Monitoring Cables
K182220 · DSA
Curbell Medical Products, Inc.
Anesthesiology · 84d
Cleared Nov 07, 2018
Simplexa GBS Direct, Simplexa GBS Positive Control Pack
K182467 · NJR
Diasorin Molecular, LLC
Microbiology · 58d
Cleared Nov 06, 2018
W Zirconia Implants
K172668 · DZE
Tav Medical , Ltd.
Dental · 427d
Cleared Nov 06, 2018
Elecsys Tacrolimus
K173857 · MLM
Roche Diagnostics
Toxicology · 321d
Cleared Nov 06, 2018
Finapres Nova Noninvasive Hemodynamic Monitor
K173916 · DXN
Finapres Medical Systems B.V.
Cardiovascular · 319d
Cleared Nov 06, 2018
ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
K180469 · FAD
Coloplast Corp.
Gastroenterology & Urology · 258d
Cleared Nov 06, 2018
SaliPen
K180838 · LTF
Saliwell , Ltd.
Dental · 221d
Cleared Nov 06, 2018
MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D
K181613 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 140d
Cleared Nov 06, 2018
Günther Tulip® Vena Cava Filter Retrieval Set
K181757 · MMX
Cook Incorporated
Cardiovascular · 127d
Cleared Nov 06, 2018
SMARTRELEASE Endoscopic Soft Tissue Release System
K181819 · HRX
Microaire Surgical Instruments, LLC
General Hospital · 120d