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
26161–26184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 2018
Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
K180078 · MAX
Innovasis, Inc.
Orthopedic · 97d
Cleared Apr 17, 2018
KARL STORZ ICG Imaging System
K180146 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 89d
Cleared Apr 17, 2018
Diode laser hair removal device
K180353 · GEX
Zhengzhou PZ Laser Slim Technology...
General & Plastic Surgery · 68d
Cleared Apr 17, 2018
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy...
K180416 · MCW
Cardiovascular Systems, Inc.
Cardiovascular · 61d
Cleared Apr 17, 2018
FOCUS Pedicle Screw System
K180458 · NKB
Nvision Biomedical Technologies, LLC
Orthopedic · 56d
Cleared Apr 17, 2018
FAST1™ Intraosseous Infusion System
K180588 · FMI
Teleflex Medical
General Hospital · 42d
Cleared Apr 17, 2018
PreludeSYNC DISTAL Radial Compression System
K180723 · DXC
Merit Medical Systems, Inc.
Cardiovascular · 29d
Cleared Apr 17, 2018
Aesculap Slim Clip Applier
K180914 · HCI
Aesculap, Inc.
Neurology · 8d
Cleared Apr 16, 2018
Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
K171603 · FAD
Cook Incorporated
Gastroenterology & Urology · 319d
Cleared Apr 16, 2018
Hemoclip
K172727 · PKL
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 217d
Cleared Apr 16, 2018
CardiMax Electrocardiograph
K173226 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 195d
Cleared Apr 16, 2018
ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6,...
K173726 · DHB
Phadia AB
Immunology · 132d
Cleared Apr 16, 2018
Mediant Anterior Cervical Plating System
K173935 · KWQ
Intelligent Implant Systems, LLC
Orthopedic · 111d
Cleared Apr 16, 2018
GDT-1000 System
K180096 · HIH
Acuvu, Inc.
Obstetrics & Gynecology · 90d
Cleared Apr 16, 2018
SOZO
K180126 · OBH
ImpediMed Limited
Gastroenterology & Urology · 90d
Cleared Apr 13, 2018
Best Instruminal Applicator
K162499 · JAQ
Best Medical International, Inc.
Radiology · 583d
Cleared Apr 13, 2018
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone...
K170463 · JIN
I-Sens, Inc.
Chemistry · 422d
Cleared Apr 13, 2018
LIGHTSonic BUBM
K170761 · IYO
Lightmed USA, Inc.
Radiology · 396d
Cleared Apr 13, 2018
ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
K170901 · CIX
Biosystems S.A.
Chemistry · 382d
Cleared Apr 13, 2018
Piezosurgery White
K171326 · DZI
Mectron S.P.A.
Dental · 343d
Cleared Apr 13, 2018
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
K171562 · ELW
Dreve Dentamid GmbH
Dental · 318d
Cleared Apr 13, 2018
uMI 780 PET/CT System
K172143 · KPS
Shanghai United Imaging Healthcare...
Radiology · 270d
Cleared Apr 13, 2018
mCare Powder-free Blue Nitrile Examination Gloves
K172930 · LZA
Mercator Medical (Thailand), Ltd.
General Hospital · 200d
Cleared Apr 13, 2018
Pivet and Soft-Pass Embryo Transfer Catheter Sets
K173103 · MQF
Cook Incorporated
Obstetrics & Gynecology · 196d