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
164833–164856 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1980
POWERED WHEELCHAIR
K802986 · ITI
Vessa , Ltd.
Physical Medicine · 28d
Cleared Dec 22, 1980
TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL
K802994 · JSH
Sacks Farms Biological Products
Microbiology · 27d
Cleared Dec 22, 1980
TRYPTICASE SOY AGAR W/5% SHEEP BLD. CELL
K802995 · JSH
Sacks Farms Biological Products
Microbiology · 27d
Cleared Dec 22, 1980
HDL-CHOLESTEROL CONTROL SERUM
K802997 · JJX
Isolab, Inc.
Chemistry · 27d
Cleared Dec 22, 1980
PATIENT CARE DISPOSABLE INFANT SHIRTS
K802998 · KME
American Convertors Div., American...
General Hospital · 27d
Cleared Dec 22, 1980
BETA-TEC QUALITATIVE
K802999 · JHI
Armkel, LLC
Chemistry · 27d
Cleared Dec 22, 1980
ELECATH FLUID-DRAIN ASSEMBLY
K803002 · DQR
Electro-Catheter Corp.
Cardiovascular · 27d
Cleared Dec 22, 1980
AMINO ACID ANALYSER SYSTEM
K803004 · JJF
Lkb Instruments, Inc.
Chemistry · 26d
Cleared Dec 22, 1980
SENSOMAT
K803014 · CBZ
Biochem International, Inc.
Anesthesiology · 24d
Cleared Dec 22, 1980
SERALYZER LDH REAGENT STRIPS, CALIBR
K803019 · CFJ
Miles Laboratories, Inc.
Chemistry · 24d
Cleared Dec 22, 1980
CDC ANAEROBE BLD AGAR W/KANAMYCIN ETC.
K803022 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 26d
Cleared Dec 22, 1980
ENRICHED THIOGLYCOLLATE MEDIUM
K803023 · JSG
Bd Becton Dickinson Vacutainer...
Microbiology · 26d
Cleared Dec 22, 1980
CDC ANAEROBE LAKED BL AGAR W/PARAMOMY.
K803024 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 26d
Cleared Dec 22, 1980
CDC ANAEROBE BLOOD AGAR
K803025 · JSG
Bd Becton Dickinson Vacutainer...
Microbiology · 26d
Cleared Dec 22, 1980
PEPTONE YEAST EXTRACT GLUCOSE BROTH
K803026 · JSC
Bd Becton Dickinson Vacutainer...
Microbiology · 26d
Cleared Dec 22, 1980
CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC.
K803027 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology
Cleared Dec 22, 1980
TLC SUPPORT PRODUCTS
K803029
Orthopedic Systems, Inc.
Orthopedic · 26d
Cleared Dec 22, 1980
THE BIO-TEK CHROMOSCAN
K803030 · JJQ
Bio-Tek Instruments, Inc.
Microbiology · 24d
Cleared Dec 22, 1980
CRUSADER HYPEREXTENSION BRACE
K803033 · IPY
Orthomedics
Physical Medicine · 21d
Cleared Dec 22, 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0623
K803034 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 21d
Cleared Dec 22, 1980
MICROTHIN-PII BIPOLAR PULSE GEN. #0621
K803035 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 21d
Cleared Dec 22, 1980
PROFILE CARDIAC SET ASSAYED SERUM CONTR.
K803036 · DIF
General Diagnostics
Toxicology · 21d
Cleared Dec 22, 1980
PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.
K803039 · DIF
General Diagnostics
Toxicology · 21d
Cleared Dec 22, 1980
SIEMENS-ELEMA ENDOCARDIAL LEAD 402S
K803042 · DTB
Siemens Elema AB
Cardiovascular · 21d