FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
12049–12072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2022
Velano Vascular Blood Collection Adapter 
K201237 · JKA
Velano Vascular
General Hospital · 879d
Cleared Oct 03, 2022
Aurolase Therapy, Laser Delivery Device (LDD)
K202953 · GEX
Nanospectra Biosciences, Inc.
General & Plastic Surgery · 733d
Cleared Oct 03, 2022
PCA Syringe Sets
K212262 · FPA
Baxter Healthcare Corporation
General Hospital · 440d
Cleared Oct 03, 2022
Varixis Elbow System
K213014 · HRS
Auxein Medical Private Limited
Orthopedic · 378d
Cleared Oct 03, 2022
ONVOY Acetabular System
K213842 · LPH
Globus Medical, Inc.
Orthopedic · 298d
Cleared Oct 03, 2022
Electronic Sphygmomanometer (Model: LT-P30)
K220220 · DXN
Zhuhai Linte Medical Instrument Co.,...
Cardiovascular · 250d
Cleared Oct 03, 2022
SILO TFX MIS Sacroiliac Joint Fixation System
K221047 · OUR
Aurora Spine, Inc.
Orthopedic · 178d
Cleared Oct 03, 2022
Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets
K221613 · QRL
Owen Mumford, Ltd.
General & Plastic Surgery · 122d
Cleared Oct 03, 2022
Disposable Safety Lancets
K221778 · FMK
Suzhou Kyuan Medical Apparatus Co., Ltd.
General & Plastic Surgery · 104d
Cleared Oct 03, 2022
Arthrex 2.4 mm Volar Distal Radius Plate System
K222267 · HRS
Arthrex, Inc.
Orthopedic · 67d
Cleared Oct 03, 2022
Elastic Traction System
K222354 · QSW
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 60d
Cleared Oct 03, 2022
Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
K222376 · FMK
Shandong Lianfa Medical Plastic...
General & Plastic Surgery · 59d
Cleared Oct 01, 2022
Disposable Nitrile Examination Glove
K222937 · LZA
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 5d
Cleared Sep 30, 2022
AugMENTA Penile Implant
K200073 · MIB
Augmenta, LLC
General & Plastic Surgery · 990d
Cleared Sep 30, 2022
8mm Monopolar Curved Scissors
K210478 · QSM
Iconocare Health
General & Plastic Surgery · 588d
Cleared Sep 30, 2022
Ultrasonic Surgical System
K210567 · LFL
Miconvey Technologies Co., Ltd.
General & Plastic Surgery · 581d
Cleared Sep 30, 2022
QIR Suite
K211611 · QIH
Casis Cardiac Simulation & Imaging...
Radiology · 493d
Cleared Sep 30, 2022
DoubleChek DC-1001
K212316 · KNT
Nasogastric Feeding Solutions, Ltd.
Gastroenterology & Urology · 431d
Cleared Sep 30, 2022
Blood Pressure Monitor(Model:Y30001)
K213023 · DXN
Zhangzhou Easepal Medical Science and...
Cardiovascular · 374d
Cleared Sep 30, 2022
Kerecis Oral
K213904 · NPL
Kerecis
Dental · 290d
Cleared Sep 30, 2022
Mg-PSZ Ceramic Femoral Head
K220336 · LPH
Theken Companies
Orthopedic · 235d
Cleared Sep 30, 2022
EmbedMed
K220366 · DZJ
3D Lifeprints UK , Ltd.
Dental · 234d
Cleared Sep 30, 2022
e-Ortho Shoulder Software v1.1
K220758 · LLZ
FH Industrie
Radiology · 199d
Cleared Sep 30, 2022
Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA...
K221003 · GDW
Covidien
General & Plastic Surgery · 178d