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
165385–165408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1980
MINI MICK APPLICATOR
K802032 · JWJ
Mick Radio-Nuclear Instruments, Inc.
Orthopedic · 62d
Cleared Oct 23, 1980
CORTISOL125 RADIOIMMUNOASSAY
K802036 · CGR
Corning Medical & Scientific
Chemistry · 62d
Cleared Oct 23, 1980
PHENYTOIN REAGENT TEST KIT
K802038 · DID
Beckman Instruments, Inc.
Toxicology · 59d
Cleared Oct 23, 1980
PHENOBARBITAL REAGENT TEST KIT
K802039 · DLZ
Beckman Instruments, Inc.
Toxicology · 59d
Cleared Oct 23, 1980
AMPCO SHAVE PREP TRAYS, CAT.#SP4020
K802041 · LDQ
Associated Medical Products Co.
General & Plastic Surgery · 65d
Cleared Oct 23, 1980
G.E. SCAN CAPABILITY CAT.#B7815F
K802045 · JAK
General Electric Co.
Radiology · 59d
Cleared Oct 23, 1980
AMX-III
K802047 · IZL
General Electric Co.
Radiology · 59d
Cleared Oct 23, 1980
ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY
K802066 · KLS
Immunotech Corp.
Immunology · 57d
Cleared Oct 23, 1980
UNIPOLAR TO BIPOLAR PULSE GEN. ADAPTER
K802077 · DTD
Cardiac Pacemakers, Inc.
Cardiovascular · 56d
Cleared Oct 23, 1980
105MM SPOT FILM CAMERA
K802132 · IZJ
Instrumentation Camera, Inc.
Radiology · 50d
Cleared Oct 23, 1980
JK INT'L, INC. SOLTRON UVA TANNING BED
K802134 · LEJ
Mottek Intl. Corp.
Radiology · 49d
Cleared Oct 23, 1980
DIGITAL RADIOGRAPHY SYSTEM
K802150 · JAA
Adac Laboratories
Radiology · 45d
Cleared Oct 23, 1980
MODEL 633A THREE CHANNEL STRESS TEST
K802190 · DPS
Quinton, Inc.
Cardiovascular · 43d
Cleared Oct 23, 1980
MINOCYCLINE 30MCG. SENSI DISC
K802194 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 43d
Cleared Oct 23, 1980
DEHYDROEPIANDROSTERONE SULFATE KIT RIA
K802195 · JKC
Radioassay Systems Laboratories, Inc.
Chemistry · 43d
Cleared Oct 23, 1980
VERTIX 3D-U
K802200 · KPR
Siemens Corp.
Radiology · 42d
Cleared Oct 23, 1980
SD-700 BLOOD PRESSURE MONITOR
K802201 · DXN
Industrial & Biomedical Sensors Corp.
Cardiovascular · 42d
Cleared Oct 23, 1980
SD-800 BLOOD PRESSURE MONITOR
K802202 · DXN
Industrial & Biomedical Sensors Corp.
Cardiovascular · 42d
Cleared Oct 23, 1980
OMNI SCANNER CT 6000
K802206 · JAK
Omnimedical
Radiology · 42d
Cleared Oct 23, 1980
SURETY COLUMN
K802209 · JKA
Scientific Specialties, Inc.
Chemistry · 41d
Cleared Oct 23, 1980
SERUM SEPARATOR
K802211 · JKA
Scientific Specialties, Inc.
Chemistry · 41d
Cleared Oct 23, 1980
COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM
K802214 · GCY
Cox-Uphuff Intl.
General & Plastic Surgery · 41d
Cleared Oct 23, 1980
VIEW-LITE, MODEL-S
K802215 · IXC
Med-Western Electronics, Inc.
Radiology · 41d
Cleared Oct 23, 1980
VIEW-LITE, MODEL-DL
K802216 · IXC
Med-Western Electronics, Inc.
Radiology · 41d