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
5665–5688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 01, 2024
Crown HT
K242277 · EBF
Sprintray, Inc.
Dental · 61d
Cleared Oct 01, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K241967 · JWY
Thermo Fisher Scientific
Microbiology · 90d
Cleared Oct 01, 2024
MuscleView
K241331 · LNH
Springbok, Inc.
Radiology · 144d
Cleared Oct 01, 2024
Disposable Endoscope Valves Set (AF series)
K241285 · ODC
Alton (Shanghai) Medical Instruments...
Gastroenterology & Urology · 147d
Cleared Oct 01, 2024
LungVision
K240943 · QIH
Bodyvision Medical , Ltd.
Radiology · 179d
Cleared Oct 01, 2024
Esperance 3+ Aspiration Catheter System
K240917 · NRY
Wallaby Medical
Neurology · 181d
Cleared Oct 01, 2024
Electric wheelchair (YHWL002, YHWL003)
K240331 · ITI
Yongkang Youha Electric Appliance...
Physical Medicine · 239d
Cleared Sep 30, 2024
CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55)
K242276 · DQY
Vantis Vascular, Inc.
Cardiovascular · 60d
Cleared Sep 30, 2024
Numen™ Coil Embolization System
K242154 · HCG
MicroPort NeuroTech (Shanghai) Co., Ltd.
Neurology · 69d
Cleared Sep 30, 2024
AQUABEAM Robotic System (AB2000)
K241952 · PZP
Procept Biorobotics
Gastroenterology & Urology · 89d
Cleared Sep 30, 2024
Kem Medical Lead-free Chemical Indicators for Steam Sterilization
K241836 · JOJ
Kem Medical Products Corporation
General Hospital · 97d
Cleared Sep 30, 2024
MSFX MIKRON SPINAL FIXATION SYSTEM
K241657 · NKB
Mikron Makina Sanayi VE Ticaret Ltd....
Orthopedic · 112d
Cleared Sep 30, 2024
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
K241317 · QYT
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 143d
Cleared Sep 30, 2024
LUXEN 5G
K241151 · EIH
Dentalmax Co., Ltd.
Dental · 158d
Cleared Sep 30, 2024
YSI 2900C Biochemistry Analyzer
K210933 · CGA
Ysi, Inc.
Chemistry · 1281d
Cleared Sep 27, 2024
Optima Coil System (OptiBlock Line Extension)
K242582 · HCG
Balt USA, LLC
Neurology · 28d
Cleared Sep 27, 2024
Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150...
K242571 · NEW
Hyundae Meditech Co., Ltd.
General & Plastic Surgery · 29d
Cleared Sep 27, 2024
ClotTriever XL Catheter (41-102)
K242557 · QEW
Inari Medical, Inc.
Cardiovascular · 30d
Cleared Sep 27, 2024
AllTest Multi-Drug Urine Test Panel
K242540 · NFT
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 32d
Cleared Sep 27, 2024
Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral...
K242213 · PPN
Shockwave Medical, Inc.
Cardiovascular · 60d
Cleared Sep 27, 2024
ACTIVO
K242206 · GEX
Daeju Meditech Engineering Co., Ltd.
General & Plastic Surgery · 60d
Cleared Sep 27, 2024
Elvie Stride 2
K242125 · HGX
Chiaro Technology, Ltd.
Obstetrics & Gynecology · 70d
Cleared Sep 27, 2024
EasyCare Tx 2
K241939 · BZD
ResMed Corp
Anesthesiology · 87d
Cleared Sep 27, 2024
HIGHERDOSE Red and Infrared Light Mask (MK66-L)
K241933 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 87d