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
5713–5736 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 26, 2024
MOLLI 2 System
K234149 · NEU
Molli Surgical, Inc.
General & Plastic Surgery · 272d
Cleared Sep 25, 2024
NovaBone Putty - Synthetic Bioactive Bone Graft
K242299 · MQV
Novabone Products, LLC
Orthopedic · 54d
Cleared Sep 25, 2024
Cove Putty, OsteoCove Putty
K242273 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 55d
Cleared Sep 25, 2024
Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I,...
K242204 · GEI
Dongguan Quanding Medical Supplies...
General & Plastic Surgery · 61d
Cleared Sep 25, 2024
Indigo® Aspiration System – Lightning Bolt Aspiration Tubing
K242075 · QEW
Penumbra, Inc.
Cardiovascular · 71d
Cleared Sep 25, 2024
Diode Laser Hair Removal System
K241860 · GEX
Beijing Winkonlaser Technology Limited
General & Plastic Surgery · 90d
Cleared Sep 25, 2024
Vybe RF II
K241535 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 118d
Cleared Sep 25, 2024
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
K240434 · HHK
Li Medical Corporation , Ltd.
Obstetrics & Gynecology · 224d
Cleared Sep 25, 2024
MOLLI 2 System
K240042 · NEU
Molli Surgical, Inc.
General & Plastic Surgery · 264d
Cleared Sep 25, 2024
IVD CAPSULE PSP
K240041 · SCX
Abionic SA
Microbiology · 264d
Cleared Sep 24, 2024
uAI Easy Triage ICH
K242292 · QAS
Shanghai United Imaging Intelligence...
Radiology · 53d
Cleared Sep 24, 2024
Ion Endoluminal System (IF 1000)
K242070 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 70d
Cleared Sep 24, 2024
Aspiration Catheter (2189)
K241874 · OCX
Hobbs Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Sep 24, 2024
Celsio Flexible Cryocatheter System
K240776 · GEH
Endocision Technologies, Inc.
General & Plastic Surgery · 187d
Cleared Sep 24, 2024
Happy Ring Health Monitoring System
K240236 · MWI
Happy Health, Inc.
Cardiovascular · 239d
Cleared Sep 24, 2024
AirFit F30i Mask System
K234134 · BZD
Resmed Pty Ltd (Registration Number:...
Anesthesiology · 270d
Cleared Sep 24, 2024
LumiVy™ Lumbar IBF System
K233807 · MAX
Vy Spine, LLC
Orthopedic · 300d
Cleared Sep 23, 2024
IPL Hair Removal Device (BE932C, BE932D, BE932E)
K241834 · OHT
Shenzhen Yang WO Electronic Co., Ltd.
General & Plastic Surgery · 90d
Cleared Sep 23, 2024
Unity Total Knee System
K241570 · JWH
Corin U.S.A. Limited
Orthopedic · 115d
Cleared Sep 23, 2024
EConsole2
K240243 · LLZ
DRTECH Corporation
Radiology · 237d
Cleared Sep 23, 2024
EchoGo Heart Failure (2.0)
K240013 · QUO
Ultromics Limited
Cardiovascular · 265d
Cleared Sep 20, 2024
zLOCK Lumbar Facet Fixation System
K242650 · MRW
Zygofix , Ltd.
Orthopedic · 16d
Cleared Sep 20, 2024
Millipede 088 Access Catheter
K242504 · NRY
Perfuze, Ltd.
Neurology · 29d
Cleared Sep 20, 2024
SuperSonic HepaVu
K242223 · IYN
Supersonic Imagine
Radiology · 53d