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
122713–122736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1991
ABUSCREEN ONLINE OPIATES CALIBRATORS
K910087 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 27d
Cleared Feb 04, 1991
ELECTRAPETTE (R)
K910140 · JQW
Matrix Technologies Corp.
Chemistry · 21d
Cleared Feb 04, 1991
KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE)
K910143 · JIY
Eastman Kodak Company
Chemistry · 21d
Cleared Feb 04, 1991
CIBA CORNING ACS LH IMMUNOASSAY
K910198 · CEP
Ciba Corning Diagnostics Corp.
Chemistry · 19d
Cleared Feb 01, 1991
VASCULAR RETRIEVAL FORCEPS
K902999 · DQY
Cook, Inc.
Cardiovascular · 207d
Cleared Feb 01, 1991
MICREL LTD PORTABLE INFUSION MICROPUMP
K903571 · FRN
Technology Transfer Intl., Inc.
General Hospital · 177d
Cleared Feb 01, 1991
HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING
K904095 · GQL
California Integrated Diagnostics, Inc.
Microbiology · 148d
Cleared Feb 01, 1991
SEXTON CYSTOTOMY URINE PUMP (SCUP2)
K904434 · KOB
Phoenix Bioengineering, Inc.
Gastroenterology & Urology · 126d
Cleared Feb 01, 1991
TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000
K904491 · DQO
Lifestream Int'L, Inc.
Cardiovascular · 122d
Cleared Feb 01, 1991
MODEL 5866-37M LEAD ADAPTOR KIT
K904575 · DTD
Medtronic Vascular
Cardiovascular · 115d
Cleared Feb 01, 1991
TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM
K904690 · DWJ
Marquest Medical Products, Inc.
Cardiovascular · 108d
Cleared Feb 01, 1991
FIRM MASTER
K905195 · LKY
Bak Medical Products
Toxicology · 74d
Cleared Feb 01, 1991
IMMULITE (TM) TOTAL T3
K905214 · CDP
Cirrus Diagnostics, Inc.
Chemistry · 73d
Cleared Feb 01, 1991
DIAVENTIONAL CATHETER
K905297 · DQO
Cordis Corp.
Cardiovascular · 66d
Cleared Feb 01, 1991
MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME
K905407 · GZB
Medtronic Vascular
Neurology · 60d
Cleared Feb 01, 1991
MAGNETIC RESONANCE DIAG. DEV. SPECIAL PURPOSE COIL
K905615 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Feb 01, 1991
SARNS INVENT CATHETERS
K905638 · DWF
3M Health Care, Sarns
Cardiovascular · 45d
Cleared Feb 01, 1991
ERCP CANNULA
K905714 · FGE
Everest Medical Corp.
Gastroenterology & Urology · 42d
Cleared Feb 01, 1991
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER
K905727 · DQO
C.R. Bard, Inc.
Cardiovascular · 39d
Cleared Feb 01, 1991
CATALOG NO. 6000-21 VOLUME NECK COIL, MODIFICATION
K905858 · LNH
Medical Advances, Inc.
Radiology · 45d
Cleared Feb 01, 1991
MAXI-FLOW SUCTION SET 12 FT.
K910170 · GAZ
Adler Instrument Co.
General Hospital · 17d
Cleared Feb 01, 1991
MAXI-FLOW SUCTION SET W/Y CONNECTOR
K910171 · GAZ
Adler Instrument Co.
General Hospital · 17d
Cleared Feb 01, 1991
LIFE O2
K910201 · BTL
Life Corp.
Anesthesiology · 14d
Cleared Jan 31, 1991
DIGIGRAPH DIAGNOSTIC WORK/STATION
K896099 · EAG
Dolphin Imaging Systems
Radiology · 468d