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
22201–22224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2019
Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination...
K182382 · LZC
Gmp Medicare Sdn Bhd (F25)
General Hospital · 363d
Cleared Aug 29, 2019
gel-e Flex+
K182811 · QSY
Gel-E, Inc.
General & Plastic Surgery · 330d
Cleared Aug 29, 2019
D2P
K183489 · LLZ
3D Systems, Inc.
Radiology · 255d
Cleared Aug 29, 2019
Spine & Trauma Navigation
K183605 · OLO
Brainlab AG
Orthopedic · 246d
Cleared Aug 29, 2019
HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module
K190205 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 206d
Cleared Aug 29, 2019
O2Vent Optima
K190236 · LRK
Oventus Manufacturing Pty, Ltd.
Dental · 204d
Cleared Aug 29, 2019
BD MAX Check-Points CPO
K190613 · POC
Check-Points Health B.V.
Microbiology · 171d
Cleared Aug 29, 2019
ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
K190744 · HET
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology · 160d
Cleared Aug 29, 2019
Concentrator with Single battery pack, carry bag with shoulder strap, back...
K191159 · CAW
Invacare Corporation
Anesthesiology · 120d
Cleared Aug 29, 2019
Omni Hysteroscope, Omni Lok cervical seal
K191281 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 108d
Cleared Aug 29, 2019
Dunamis Fixation Button System
K191319 · MBI
Dunamis, LLC
Orthopedic · 106d
Cleared Aug 29, 2019
OverStitch 2-0 Polypropylene Suture
K191439 · OCW
Apollo Endosurgery
General & Plastic Surgery · 91d
Cleared Aug 29, 2019
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic...
K191475 · KCT
Nobel Biocare AB
General Hospital · 86d
Cleared Aug 29, 2019
Yushan X-Ray Flat Panel Detector
K191939 · MQB
Innocare Optoelectronics Corp.
Radiology · 41d
Cleared Aug 29, 2019
EvaQMax Smoke Evacuation System
K192035 · FYD
Bio Protech, Inc.
General Hospital · 30d
Cleared Aug 29, 2019
ClotTriever Thrombectomy System
K192036 · QEW
Inari Medical
Cardiovascular · 30d
Cleared Aug 29, 2019
Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed,...
K192042 · NPL
Geistlich Pharma AG
Dental · 29d
Cleared Aug 29, 2019
Endoskeleton TAS Plate
K192054 · OVD
Titan Spine, Inc.
Orthopedic · 29d
Cleared Aug 29, 2019
Binary® Anterior Cervical Plate System
K192076 · KWQ
Genesys Spine
Orthopedic · 27d
Cleared Aug 29, 2019
Clarius Ultrasound Scanner
K192107 · IYN
Clarius Mobile Health Corp.
Radiology · 24d
Cleared Aug 29, 2019
Voluson E6, Voluson E8, Voluson E10
K192159 · IYN
Ge Healthcare
Radiology · 20d
Cleared Aug 28, 2019
FEMME Applicator Tampon
K182142 · HEB
Jiangsu Yoai Technology Co., Ltd.
Obstetrics & Gynecology · 386d
Cleared Aug 28, 2019
B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T...
K182401 · MWI
Amzetta Technologies Private Limited
Cardiovascular · 358d
Cleared Aug 28, 2019
CryoVizion System
K183485 · LDK
Cryos Technologies, Inc.
Physical Medicine · 254d