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
75625–75648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 2002
D.SIGN 15 (DW286 B)
K020898 · EJH
Ivoclar Vivadent, Inc.
Dental · 64d
Cleared Mar 29, 2002
EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO
K020973 · GEX
Surgilight, Inc.
General & Plastic Surgery · 3d
Cleared Mar 28, 2002
SURETONE
K011588 · IPF
Suretone International
Physical Medicine · 309d
Cleared Mar 28, 2002
THE HAMMER MODEL H100
K012041 · DXC
Tenacore Holdings, Inc.
Cardiovascular · 272d
Cleared Mar 28, 2002
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM
K013551 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 155d
Cleared Mar 28, 2002
CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP
K013714 · FPA
Codan US Corp.
General Hospital · 140d
Cleared Mar 28, 2002
IMMULITE BR-MA, MODEL #LKBR
K013984 · MOI
Diagnostic Products Corp.
Immunology · 115d
Cleared Mar 28, 2002
ORTHOSS RESORBABLE BONE VOID FILLER
K014289 · LYC
Geistlich-Pharma
Dental · 90d
Cleared Mar 28, 2002
ENTEC PLASMA WANDS
K014290 · GEI
Arthrocare Corp.
General & Plastic Surgery · 90d
Cleared Mar 28, 2002
UNIFIL FLOW
K020342 · EBF
GC America, Inc.
Dental · 55d
Cleared Mar 28, 2002
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
K020441 · DIO
Dade Behring, Inc.
Toxicology · 45d
Cleared Mar 28, 2002
PBS, PBSW WITH CATIONS AND PHENOL RED
K020490 · MQL
Conception Technologies
Obstetrics & Gynecology · 43d
Cleared Mar 28, 2002
ARTHROCARE CONTROLLER
K020621 · GEY
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared Mar 28, 2002
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000)
K020622 · GEI
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared Mar 28, 2002
MODIFICATION TO SPARC SLING SYSTEM
K020663 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 27d
Cleared Mar 28, 2002
CODMAN HAKIM SHUNT SYSTEMS
K020667 · JXG
Codman & Shurtleff, Inc.
Neurology · 27d
Cleared Mar 28, 2002
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB
K020669 · DTB
Oscor, Inc.
Cardiovascular · 27d
Cleared Mar 28, 2002
HEMOCHRON JR. SIGNATURE +
K020798 · JPA
International Technidyne Corp.
Hematology · 16d
Cleared Mar 27, 2002
MRSA-SCREEN
K011400 · MYI
Denka Seiken'S
Microbiology · 324d
Cleared Mar 27, 2002
GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
K012520 · DRF
Cardiac Assist Devices, Inc.
Cardiovascular · 233d
Cleared Mar 27, 2002
GLASS POST
K012849 · ELR
J. Morita USA, Inc.
Dental · 236d
Cleared Mar 27, 2002
WIZAIR DVT
K012994 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 202d
Cleared Mar 27, 2002
SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
K013488 · JXG
Sophysa SA
Neurology · 159d
Cleared Mar 27, 2002
OMNI OXYGEN SYSTEM, MODEL 1000
K013931 · CAW
Sequal Technologies, Inc.
Anesthesiology · 119d