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
24937–24960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2018
Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine...
K181390 · NKB
OrthoPediatrics Corp.
Orthopedic · 112d
Cleared Sep 18, 2018
Endoscopic Linear Cutting Staplers and Loading Units for Single Use
K181620 · GDW
Ezisurg (Suzhou) Medical Co., Ltd.
General & Plastic Surgery · 90d
Cleared Sep 18, 2018
Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
K181653 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 88d
Cleared Sep 18, 2018
BioSign Flu A+B
K182157 · PSZ
Princeton BioMeditech Corp.
Microbiology · 40d
Cleared Sep 18, 2018
The CVC WAND Safety Introducer with Valved Peelable Sheath
K182243 · DYB
Access Scientific, LLC
Cardiovascular · 29d
Cleared Sep 17, 2018
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
K173871 · NAJ
Suzhou Hengrui Callisyn Biomedical...
Obstetrics & Gynecology · 271d
Cleared Sep 17, 2018
DenTek Ultimate Dental Guard
K180933 · OBR
Medtech Products, Inc.
Dental · 160d
Cleared Sep 17, 2018
Venacure 1470 Pro
K181632 · GEX
Quanta System Spa
General & Plastic Surgery · 89d
Cleared Sep 17, 2018
Ceracell Ortho Foam
K181721 · MQV
Curasan AG
Orthopedic · 80d
Cleared Sep 17, 2018
PALACOS MV
K182260 · LOD
Heraeus Medical GmbH
Orthopedic · 27d
Cleared Sep 15, 2018
ThermaCare Quick Therapy TENS
K181102 · NUH
Pfizer, Inc.
Neurology · 142d
Cleared Sep 14, 2018
A-FIT
K173676 · GEX
Hironic Co., Ltd.
General & Plastic Surgery · 288d
Cleared Sep 14, 2018
LightScalpel
K173827 · GEX
Lightscalpel, LLC
General & Plastic Surgery · 270d
Cleared Sep 14, 2018
Impress SFS System
K173910 · JDQ
Cable Fix Medical, LLC
Orthopedic · 266d
Cleared Sep 14, 2018
DORADOnova MR3T
K173926 · IYE
Lap GmbH Laser Applikationen
Radiology · 262d
Cleared Sep 14, 2018
Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access...
K180182 · EYB
Cook Incorporated
Gastroenterology & Urology · 234d
Cleared Sep 14, 2018
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
K180369 · GXI
Relievant Medsystems
Neurology · 214d
Cleared Sep 14, 2018
Portable Nebulizer
K180871 · CAF
Microbase Technology Corporation
Anesthesiology · 164d
Cleared Sep 14, 2018
POLY REJUV
K180875 · OHS
Medtek Skincare, LLC
General & Plastic Surgery · 164d
Cleared Sep 14, 2018
Prime E-CLASS XLPE Liner
K181598 · LZO
Microport Orthopedics, Inc.
Orthopedic · 88d
Cleared Sep 14, 2018
MX40 Mobile Digital X-ray System
K181874 · IZL
Huestis Machine Corporation
Radiology · 63d
Cleared Sep 14, 2018
QT Ultrasound Breast Scanner - 1
K182213 · IYO
Qt Ultrasound, LLC
Radiology · 30d
Cleared Sep 14, 2018
DizzyDoctor System 1.0.0
K182214 · GWN
Dizzydoctor Systems, LLC
Ear, Nose, Throat · 30d
Cleared Sep 14, 2018
Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
K182223 · JAK
Canon Medical Systems, USA
Radiology · 29d