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
19201–19224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 2020
SIGNA Artist
K202238 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 28d
Cleared Sep 04, 2020
Ambra ProViewer
K202335 · LLZ
Dicom Grid Inc Dba Ambra Health
Radiology · 18d
Cleared Sep 03, 2020
Biodegradable Nitrile Examination Powder Free Glove, Green
K192111 · LZA
Top Glove Sdn. Bhd.
General Hospital · 395d
Cleared Sep 03, 2020
Lyograft
K192452 · FTM
B. Bruan Surgical, SA
General & Plastic Surgery · 360d
Cleared Sep 03, 2020
BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450...
K193599 · ITI
21st Century Scientific, Inc.
Physical Medicine · 255d
Cleared Sep 03, 2020
MIS Dental Implant System
K200102 · DZE
Dentsply Sirona
Dental · 230d
Cleared Sep 03, 2020
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K200212 · MTD
Innovative Health, LLC
Cardiovascular · 219d
Cleared Sep 03, 2020
HaloGUARD Protective Disc with CHG
K200641 · FRO
Attwill Medical Solutions
General & Plastic Surgery · 176d
Cleared Sep 03, 2020
Delta III Lithotripter
K201074 · LNS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 134d
Cleared Sep 03, 2020
Cliq Aspirator
K201203 · BTA
Anest Iwata Sparmax Co., Ltd.
General & Plastic Surgery · 122d
Cleared Sep 03, 2020
3MP Color LCD Monitors C32S+, C32SP+
K201211 · PGY
Shenzhen Beacon Display Technology...
Radiology · 121d
Cleared Sep 03, 2020
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary...
K201336 · JDS
Synthes USA Products, LLC
Orthopedic · 106d
Cleared Sep 03, 2020
Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
K201522 · HTN
Arthrex, Inc.
Orthopedic · 87d
Cleared Sep 03, 2020
Flat Panel Detector
K201591 · MQB
Ka Imaging, Inc.
Radiology · 83d
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