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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
140305–140328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 23, 1987
S.C.M.T. PERFORATOR
K871087 · HGE
Salt Creek Medical Technologies
Obstetrics & Gynecology · 5d
Cleared Mar 20, 1987
SHELF LIFE CHANGE OF STERILE DEVICES
K864090 · DRS
Utah Medical Products, Inc.
Cardiovascular · 178d
Cleared Mar 20, 1987
TARGET THERAPEUTICS TAPER GUIDE WIRE
K864316 · DQX
Target Therapeutics
Cardiovascular · 137d
Cleared Mar 20, 1987
THE BUDDY SYSTEM/HEALTH INFORMATION SYSTEM
K864318 · DXN
The Buddy Systems, Inc.
Cardiovascular · 137d
Cleared Mar 20, 1987
CARDIOVIT AT-6
K864465 · DPS
Schiller Corp.
Cardiovascular · 128d
Cleared Mar 20, 1987
CARDIAN III CR6A
K864704 · DPS
Cardiac Recorders, Ltd.
Cardiovascular · 108d
Cleared Mar 20, 1987
PM-8 HEART RATE MONITOR
K864748 · DRT
Pulse Time Products, Ltd.
Cardiovascular · 105d
Cleared Mar 20, 1987
KIRSCHNER (R) SMALL FRAGMENT FIXATION SYSTEM
K864924 · HRS
Kirschner Medical Corp.
Orthopedic · 94d
Cleared Mar 20, 1987
NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST
K870117 · JSX
Pro-Lab, Inc.
Microbiology · 67d
Cleared Mar 20, 1987
MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS
K870216 · JDI
Osteonics Corp.
Orthopedic · 59d
Cleared Mar 20, 1987
P.T.H. METAL-BACKED ACETABULAR CUP
K870234 · JDL
Orthopaedic Device Corp.
Orthopedic · 58d
Cleared Mar 20, 1987
STERILE PROCEDURAL TRAYS
K870373 · KDD
Dimed, Intl.
General & Plastic Surgery · 50d
Cleared Mar 20, 1987
THREADED ACETABULAR COMPONENT
K870445 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 45d
Cleared Mar 20, 1987
IODOSORB POWDER
K870559 · KOZ
Perstorp AB C/O Robert Joel Slomoff
General & Plastic Surgery · 38d
Cleared Mar 20, 1987
RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE
K870610 · DTB
Telectronics, Inc.
Cardiovascular · 46d
Cleared Mar 20, 1987
SATLITE/PB251 PULSE OXIMETER
K870621 · DQA
Datex Division Instrumentarium Corp.
Anesthesiology · 36d
Cleared Mar 20, 1987
HEARTECH HFX, HEARING AID
K870723 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 24d
Cleared Mar 20, 1987
EMIT NORTRIPTYLINE ASSAY
K870823 · LFG
Syva Co.
Toxicology · 17d
Cleared Mar 20, 1987
ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035
K870824 · DTB
Pacesetter Systems
Cardiovascular · 66d
Cleared Mar 20, 1987
EDEC 80 CONSTANT POTENTIAL X-RAY GENERATOR
K870851 · IZO
Electromed Intl., Ltd.
Radiology · 17d
Cleared Mar 20, 1987
LOOK RETROBULBAR NEEDLES
K870902 · HMX
Look, Inc.
Ophthalmic · 15d
Cleared Mar 19, 1987
CANDIDATE(R) SUPER
K863499 · LRF
Mercia Diagnostics , Ltd.
Microbiology · 191d
Cleared Mar 19, 1987
THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT
K863913 · DOE
Diagnostic Products Corp.
Toxicology · 162d
Cleared Mar 19, 1987
ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001
K864500 · LQY
Analytic Technology
Dental · 125d