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
23929–23952 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 06, 2018
ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate...
K181846 · KWQ
Globus Medical, Inc.
Orthopedic · 118d
Cleared Nov 06, 2018
Vivid T8, Vivid T9
K181934 · IYN
GE Medical Systems Ultrasound &...
Radiology · 110d
Cleared Nov 06, 2018
icobrain
K181939 · LLZ
Icometrix NV
Radiology · 110d
Cleared Nov 06, 2018
Merit Syringe
K182216 · FMF
Merit Medical Systems, Inc.
General Hospital · 83d
Cleared Nov 06, 2018
Merit Syringe
K182279 · FMF
Merit Medical Systems, Inc.
General Hospital · 76d
Cleared Nov 06, 2018
Universal Mesh - Sterile
K182425 · GWO
Stryker Leibinger GmbH & Co KG
Neurology · 61d
Cleared Nov 06, 2018
MiniGuard Arterial Safety Valve
K182442 · MJJ
Quest Medical, Inc.
Cardiovascular · 60d
Cleared Nov 06, 2018
ERBEFLO Olympus Scope Port Connector
K182444 · OCX
Erbe USA, Inc.
Gastroenterology & Urology · 60d
Cleared Nov 06, 2018
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
K182451 · GEI
Covidien, LLC
Ear, Nose, Throat · 60d
Cleared Nov 05, 2018
Actreen Hi-Lite Cath, Actreen Hi-Lite Set
K180801 · GBM
B.Braun Medical, Inc.
Gastroenterology & Urology · 222d
Cleared Nov 05, 2018
ConnectedOR Hub with Device and Voice Control
K181258 · GCJ
Stryker
General & Plastic Surgery · 178d
Cleared Nov 05, 2018
Athelas One
K181288 · GKZ
Athelas, Inc.
Hematology · 173d
Cleared Nov 05, 2018
DynaClipTM Bone Staple
K181781 · JDR
MedShape, Inc.
Orthopedic · 125d
Cleared Nov 05, 2018
Tina-quant Transferrin ver.2 (urine application)
K182095 · DDG
Roche Diagnostics Operations (Rdo)
Immunology · 94d