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
18625–18648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 03, 2020
Cavetto [MAX] Cervical Cage System
K201769 · ODP
Neurostructures, Inc.
Orthopedic · 66d
Cleared Sep 03, 2020
3D GraftRasp System
K201900 · FMF
Surgentec
Orthopedic · 57d
Cleared Sep 03, 2020
7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D...
K201966 · OLO
7D Surgical, Inc.
Orthopedic · 50d
Cleared Sep 03, 2020
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
K202176 · MSD
Medical Components, Inc. (dba MedComp)
Gastroenterology & Urology · 30d
Cleared Sep 03, 2020
ArtPIX DRF
K202235 · JAA
Cmt Medical Technologies, Ltd.
Radiology · 27d
Cleared Sep 03, 2020
Diamond Digital Sleep Orthotic (DDSO)
K202499 · LRK
Diamond Orthotic Laboratory
Dental · 3d
Cleared Sep 02, 2020
Endofresh Digestive Endoscopy System
K192704 · FDS
Huizhou Xzing Technology Co., Ltd.
Gastroenterology & Urology · 341d
Cleared Sep 02, 2020
Bright Temporary C&B
K192830 · EBG
Dmp Dental Industry S.A.
Dental · 336d
Cleared Sep 02, 2020
Simplant Digital Guide
K193405 · NDP
Dentsply Sirona
Dental · 268d
Cleared Sep 02, 2020
ExactechGPS System
K193618 · OLO
Blue Ortho
Orthopedic · 251d
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