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

Filters: Cleared only ×
175,820 results
27505–27528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 15, 2017
U50 Diagnostic Ultrasound System
K173003 · IYN
Edan Instruments, Inc.
Radiology · 49d
Cleared Nov 15, 2017
Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color
K173016 · LYZ
Anhui Kindguard Medical Supplies...
General Hospital · 49d
Cleared Nov 15, 2017
Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and...
K173289 · DQO
Cook Incorporated
Cardiovascular · 30d
Cleared Nov 15, 2017
jFit Surgical Planner
K173329 · LLZ
Jointvue, LLC
Radiology · 23d
Cleared Nov 14, 2017
AP 50/30 Insufflator with Insuflow Port
K170799 · HIF
Lexion Medical, LLC
Obstetrics & Gynecology · 242d
Cleared Nov 14, 2017
Dolphin/IQ and Dolphin/4D
K170859 · IYN
Viasonix , Ltd.
Radiology · 237d
Cleared Nov 14, 2017
Planmeca Romexis
K171385 · LLZ
Planmeca Oy
Radiology · 187d
Cleared Nov 14, 2017
Straumann PURE Ceramic Implants
K171769 · DZE
Straumann USA, LLC (On Behalf of...
Dental · 153d
Cleared Nov 14, 2017
DePuy Synthes Femoral Recon Nail System
K172157 · HSB
Synthes USA Products, LLC
Orthopedic · 119d
Cleared Nov 14, 2017
Biograph mMR with mMR Angio Transfer Option
K172531 · OUO
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Nov 14, 2017
Smart External Drain (SED) System
K172759 · JXG
Aqueduct Critical Care, Inc.
Neurology · 62d
Cleared Nov 14, 2017
FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
K173034 · IYO
Echosens
Radiology · 47d
Cleared Nov 14, 2017
n!ce for Planmill
K173410 · EIH
Institut Straumann AG
Dental · 13d
Cleared Nov 13, 2017
IMPIX 3D Print Cages
K163595 · MAX
Medicrea International SA
Orthopedic · 327d
Cleared Nov 13, 2017
Pekkton Ivory
K170102 · EBF
Cendres & Metaux SA
Dental · 306d
Cleared Nov 13, 2017
Access AMH
K170524 · PQO
Beckman Coulter, Inc.
Chemistry · 264d
Cleared Nov 13, 2017
Stryker Universal Mesh
K170725 · GWO
Stryker
Neurology · 249d
Cleared Nov 13, 2017
CXI TriForce Peripheral Crossing Set
K170931 · KRA
Cook Incorporated
Cardiovascular · 229d
Cleared Nov 13, 2017
Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)
K172344 · KNW
Medax Srl Unipersonale
Gastroenterology & Urology · 103d
Cleared Nov 13, 2017
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with...
K172525 · LZC
Central Medicare Sdn Bhd
General Hospital · 84d
Cleared Nov 13, 2017
Disposable Snap Electrode
K172703 · GXY
Embla Systems
Neurology · 67d
Cleared Nov 13, 2017
ANTHEM Fracture System
K173166 · HRS
Globus Medical, Inc.
Orthopedic · 45d
Cleared Nov 11, 2017
A1AT Genotyping Test
K171868 · PZH
Progenika Biopharma S.A., A Grifols...
Immunology · 142d
Cleared Nov 10, 2017
Nexstim Navigated Brain Therapy (NBT) System 2
K171902 · OBP
Nexstim Plc
Neurology · 137d