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
19153–19176 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 2020
CD Horizon™ Spinal System
K201407 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 105d
Cleared Sep 10, 2020
Straight T Clear Dental Aligner
K201450 · NXC
Straight T, Inc.
Dental · 101d
Cleared Sep 10, 2020
Diode Laser Body Sculpture System
K201731 · PKT
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 78d
Cleared Sep 10, 2020
SubNovii Advanced Plasma Technology
K201738 · GEI
Cartessa Aesthetics
General & Plastic Surgery · 77d
Cleared Sep 10, 2020
RxSight Contact Lens
K201909 · HJK
Rxsight, Inc.
Ophthalmic · 63d
Cleared Sep 10, 2020
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
K201944 · JEY
Synthes USA Products, LLC
Dental · 59d
Cleared Sep 10, 2020
Disposable Vinyl Glove
K202008 · LYZ
Best Care Trading Co., Ltd.
General Hospital · 51d
Cleared Sep 10, 2020
DIAMOND-5A/6A/8A
K202156 · KPR
DRGEM Corporation
Radiology · 45d
Cleared Sep 10, 2020
HS Fiber
K202242 · GAT
Riverpoint Medical, LLC
General & Plastic Surgery · 31d
Cleared Sep 09, 2020
MINT Product Family
K192423 · NEW
Hans Biomed Corporation
General & Plastic Surgery · 371d
Cleared Sep 09, 2020
Perseus
K192653 · OLO
Orthokey Italia S.R.L.
Orthopedic · 351d
Cleared Sep 09, 2020
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
K192730 · CHW
Biosystems S.A.
Chemistry · 348d
Cleared Sep 09, 2020
Benesta Hysteroscope
K192822 · HIH
Caldera Medical, Inc.
General Hospital · 344d
Cleared Sep 09, 2020
Vista Rinse, Vista Rinse Plus
K193409 · KJJ
Inter-Med/Vista Dental Products
Dental · 275d
Cleared CT Sep 09, 2020
ClotTriever Thrombectomy System
K193462 · QEW
Inari Medical
Cardiovascular · 268d
Cleared Sep 09, 2020
SubQKath Catheter and Needle Set
K193664 · BSO
Hk Surgical
Anesthesiology · 253d
Cleared Sep 09, 2020
Blood Collection Needle with/without Holder, Safety Blood Collection Needle...
K200027 · JKA
Jiangsu Caina Medical Co.,Ltd
General Hospital · 247d
Cleared Sep 09, 2020
Vivid iq
K200708 · IYN
Ge Medical Systems Ultrasound And
Radiology · 175d
Cleared Sep 09, 2020
Vivid T8, Vivid T9
K200851 · IYN
GE Medical Systems Ultrasound and...
Radiology · 162d
Cleared Sep 09, 2020
Structur CAD
K201090 · EBG
Voco GmbH
Dental · 139d
Cleared Sep 09, 2020
Spectralis HRA+OCT and variants
K201252 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 121d
Cleared Sep 09, 2020
Keeogo Dermoskeleton System
K201539 · PHL
B-Temia, Inc.
Neurology · 92d
Cleared Sep 09, 2020
KetoSens BT Blood B-Ketone Monitoring System
K201551 · JIN
I-Sens, Inc.
Chemistry · 92d
Cleared Sep 09, 2020
DePuy Synthes Variable Angle Locking Patella Plating System
K201578 · HRS
Synthes USA Products, LLC
Orthopedic · 90d