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
24529–24552 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 05, 2018
1688 Camera Control Unit
K182160 · GCJ
Stryker
General & Plastic Surgery · 88d
Cleared Nov 05, 2018
PREMIER Platinum HpSA PLUS
K182559 · LYR
Meridian Bioscience, Inc.
Microbiology · 49d
Cleared Nov 02, 2018
HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus...
K180180 · MQR
M.I. Tech Co., Ltd.
Gastroenterology & Urology · 283d
Cleared Nov 02, 2018
Sheridan Endobronchial Tubes
K180253 · CBI
Teleflex Medical
Anesthesiology · 276d
Cleared Nov 02, 2018
Invia White Foam NPWT
K180415 · OMP
Medela AG
General & Plastic Surgery · 260d
Cleared Nov 02, 2018
Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under...
K180601 · OAS
Villa Sistemi Medicali S.P.A.
Radiology · 240d
Cleared Nov 02, 2018
Sterile Nitrile Powder Free Examination Glove Tested for Use with...
K180786 · LZA
Hartalega Sdn Bhd
General Hospital · 221d
Cleared Nov 02, 2018
ClearPoint System
K181195 · ORR
Mri Interventions, Inc.
Neurology · 182d
Cleared Nov 02, 2018
Vygon Midline 3 Fr SL Catheter
K181208 · PND
Vygon USA
General Hospital · 179d
Cleared Nov 02, 2018
Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
K181403 · OWB
Ge Healthcare
Radiology · 157d