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
19225–19248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 2020
EtchPro Etching Gel
K200462 · KLE
Belport Company, Inc., Gingi-Pak
Dental · 190d
Cleared Sep 02, 2020
ATL Anchors
K200503 · MBI
International Life Sciences
Orthopedic · 184d
Cleared Sep 02, 2020
OCT-Camera ID 21101A3
K200516 · OBO
Optomedical Technologies GmbH
Ophthalmic · 184d
Cleared Sep 02, 2020
VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE...
K200812 · OBJ
Philips Image Guided Therapy Corporation
Cardiovascular · 159d
Cleared Sep 02, 2020
LOCATOR R-Tx
K200827 · NHA
Ivory Super Holdco, Incp.
Dental · 156d
Cleared Sep 02, 2020
RX-1 Rhythm Express Remote Cardiac Monitoring System
K200833 · MLO
Vivaquant, Inc.
Cardiovascular · 156d
Cleared Sep 02, 2020
Oral-B Dry Mouth Oral Rinse
K201277 · LFD
The Procter & Gamble Company
Dental · 112d
Cleared Sep 02, 2020
ApolloVue S100 Image System
K201552 · NQQ
Apollo Medical Optics, Ltd.
General & Plastic Surgery · 84d
Cleared Sep 02, 2020
Arthrex Mesh Plates
K201677 · HRS
Arthrex, Inc.
Orthopedic · 75d
Cleared Sep 02, 2020
SmartHDM-510 System
K201765 · FIZ
Mesa Laboratories, Inc.
Gastroenterology & Urology · 65d
Cleared Sep 02, 2020
Aesculap PAS-Port Proximal Anastomosis System
K202124 · FZP
Aesculap, Inc.
General & Plastic Surgery · 33d
Cleared Sep 02, 2020
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal...
K202169 · KFM
Qura S.R.L
Cardiovascular · 30d
Cleared Sep 02, 2020
ZOOM (71, 55, 45, 35) Reperfusion Catheters
K202182 · NRY
Imperative Care, Inc.
Neurology · 29d
Cleared Sep 02, 2020
cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
K202215 · QMI
Roche Molecular Systems, Inc.
Microbiology · 27d
Cleared Sep 02, 2020
EPIQ Series Diagnostic Ultrasound Systems
K202216 · IYN
Philips Ultrasound, Inc.
Radiology · 27d
Cleared Sep 01, 2020
Resolution 360™ ULTRA Clip
K193424 · PKL
Boston Scientific Corporation
Gastroenterology & Urology · 266d
Cleared Sep 01, 2020
VICTUS Femtosecond Laser Platform
K200724 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 166d
Cleared Sep 01, 2020
Patient Administration Set
K200916 · IYT
Cyclomedica Australia Pty, Ltd.
Radiology · 148d
Cleared Sep 01, 2020
Image1 S CCU, Image1 S 4U Camera Head
K201135 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 126d
Cleared Sep 01, 2020
CAPOGEN Laser Cap
K201854 · OAP
Nature, Inc.redible, Inc.
General & Plastic Surgery · 57d
Cleared Sep 01, 2020
Endoscope Reprocessor OER-Elite
K201920 · FEB
Olympus Medical Systems Corp.
General Hospital · 53d
Cleared Sep 01, 2020
Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz...
K202160 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 29d
Cleared Aug 31, 2020
TrueTear Intranasal Tear Neurostimulator
K193589 · QBR
Allergan
Ophthalmic · 252d
Cleared Aug 31, 2020
KLS Martin Individual Patient Solutions (IPS) Planning System
K201052 · PPT
KLS-Martin L.P.
Neurology · 132d