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
14353–14376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 2022
SONON Ultrasound Imaging System, Model: SONON 500L
K212400 · IYN
Healcerion Co., Ltd.
Radiology · 263d
Cleared Apr 22, 2022
RibFix Blu Thoracic Fixation System
K212608 · HRS
Biomet Microfixation
Orthopedic · 248d
Cleared Apr 22, 2022
Lorals
K212928 · MSC
Brazen Goods Inc. Dba Lorals
Obstetrics & Gynecology · 220d
Cleared Apr 22, 2022
MirrorMe3D Modeling System
K212981 · LLZ
Mirrorme3D, LLC
Radiology · 217d
Cleared Apr 22, 2022
ATUSA™ Automated 3D Breast Ultrasound System
K213620 · IYO
Isono Health, Inc.
Radiology · 157d
Cleared Apr 22, 2022
Promisemed Fine Biopsy Needle
K213683 · KNW
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 151d
Cleared Apr 22, 2022
ROSA® Knee System
K213708 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 149d
Cleared Apr 22, 2022
PicoStar
K213889 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 130d
Cleared Apr 22, 2022
HealthOST
K213944 · JAK
Nanoxai , Ltd.
Radiology · 126d
Cleared Apr 22, 2022
HYBRID S70
K220574 · EHD
Digimed Co., Ltd.
Radiology · 53d
Cleared Apr 22, 2022
Avanos* CORTRAK* 2 Enteral Access System (EAS)
K220588 · KNT
Avanos Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Apr 22, 2022
1 Series Phototherapy Equipment
K220840 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 30d
Cleared Apr 22, 2022
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688...
K220895 · GCJ
Stryker
General & Plastic Surgery · 25d
Cleared Apr 21, 2022
Waterlase iPLus
K210183 · GEX
Biolase, Inc.
General & Plastic Surgery · 451d
Cleared Apr 21, 2022
HydroMARK Breast Biopsy Site Marker
K212158 · NEU
Devicor Medical Products, Inc.
General & Plastic Surgery · 283d
Cleared Apr 21, 2022
Tempo Tampon
K212277 · HEB
Dong-A Pharmaceutical Co., Ltd.
Obstetrics & Gynecology · 275d
Cleared Apr 21, 2022
INHANCE™ Reverse Shoulder System
K212737 · PHX
Depuy Ireland UC
Orthopedic · 234d
Cleared CT Apr 21, 2022
GEMS-H
K213452 · PHL
Samsung Electronics Co., Ltd.
Neurology · 177d
Cleared Apr 21, 2022
FEMTO LDV Z8 Femtosecond Surgical Laser
K213559 · OOE
Sie Ag,Surgical Instrument Engineering
Ophthalmic · 168d
Cleared Apr 21, 2022
Ivory Glove Powder-Free Nitrile Examination Gloves
K213681 · LZA
Ivory Gloves Sdn. Bhd.
General Hospital · 150d
Cleared Apr 21, 2022
MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
K213730 · JOM
Mesi, Development of Medical Devices,...
Cardiovascular · 146d
Cleared Apr 21, 2022
Videa Caries Assist
K213795 · MYN
Videahealth, Inc.
Radiology · 136d
Cleared Apr 21, 2022
GM85
K220175 · IZL
Samsung Electronics Co., Ltd.
Radiology · 90d
Cleared Apr 21, 2022
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy...
K220382 · LZA
Jiangsu Bytech Medical Supplies Co.,...
General Hospital · 70d