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
7609–7632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 2024
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic...
K233788 · IYN
Philips Ultrasound, LLC
Radiology · 77d
Cleared Feb 13, 2024
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K233740 · LZA
W.A. Rubbermate Co., Ltd.
General Hospital · 83d
Cleared Feb 13, 2024
Transorb™ Self-Gripping Resorbable Mesh
K233661 · OWT
Sofradim Production
General & Plastic Surgery · 90d
Cleared Feb 13, 2024
EXPD 4343S
K232082 · MQB
DRTECH Corporation
Radiology · 215d
Cleared Feb 13, 2024
Apex Locator
K231990 · LQY
Cefla S.C.
Dental · 223d
Cleared Feb 13, 2024
QOCA® image Smart RT Contouring System
K231855 · QKB
Quanta Computer, Inc.
Radiology · 235d
Cleared Feb 13, 2024
VerteLoc Spinal System
K231134 · MQP
Signature Orthopaedics Pty, Ltd.
Orthopedic · 298d
Cleared Feb 12, 2024
Facial Toning device (UIC-189)
K233667 · NFO
Body Trim Industrial Co., Ltd.
Neurology · 89d
Cleared Feb 12, 2024
SPY Cystoscope/Hysteroscope
K233635 · HIH
Stryker Endoscopy
Obstetrics & Gynecology · 91d
Cleared Feb 12, 2024
NerveTape
K233533 · JXI
Biocircuit Technologies, Inc.
Neurology · 102d
Cleared Feb 12, 2024
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
K233401 · IYO
Eieling Technology Limited
Radiology · 131d
Cleared Feb 12, 2024
Univers Revers CA Head and Adapter
K233260 · HSD
Arthrex, Inc.
Orthopedic · 136d
Cleared Feb 12, 2024
Mimics Cardiac Planner
K233217 · LLZ
Materialise NV
Radiology · 137d
Cleared Feb 12, 2024
I.T.S. INS Proximal Femur Nail
K233134 · HSB
I.T.S. GmbH
Orthopedic · 138d
Cleared Feb 12, 2024
Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W)
K233092 · NUH
Chongqing Rob Linka Science and...
Neurology · 139d
Cleared Feb 12, 2024
EMS/TENS Massager Device
K233040 · NUH
Shenzhen Imdk Medical Technology Co.,...
Physical Medicine · 140d
Cleared Feb 12, 2024
PainFreeze II
K232674 · MLY
Nuance Medical, LLC
Physical Medicine · 164d
Cleared Feb 12, 2024
Endoscopic Video Image Processor, Single-Use Video Hysteroscope
K232003 · HIH
Guangzhou Red Pine Medical Instrument...
Obstetrics & Gynecology · 221d
Cleared Feb 12, 2024
SCOUT MD Surgical Guidance System
K231468 · NEU
Merit Medical System, Inc.
General & Plastic Surgery · 266d
Cleared Feb 09, 2024
DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)
K240098 · ODC
STERIS Corporation
Gastroenterology & Urology · 28d
Cleared Feb 09, 2024
V-STRUT® Vertebral Implant
K240084 · NDN
Hyprevention
Orthopedic · 29d
Cleared Feb 09, 2024
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use...
K240072 · LZA
Luliang Hongruida Health Protection...
General Hospital · 30d
Cleared Feb 09, 2024
Fine Osteotomy™
K240066 · PBF
Bodycad Laboratories, Inc.
Orthopedic · 31d
Cleared Feb 09, 2024
CATS-L Tonometer™ Prism
K234037 · HKY
Cats Tonometer, LLC
Ophthalmic · 50d