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
140449–140472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1987
INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT
K870828 · CHH
Intersect Systems, Inc.
Chemistry · 10d
Cleared Mar 13, 1987
SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR
K870844 · HWB
Warsaw Orthopedic, Inc.
Orthopedic · 10d
Cleared Mar 13, 1987
SCHULTZ MP COMPONENT PUNCH
K870846 · HWP
Warsaw Orthopedic, Inc.
Orthopedic · 10d
Cleared Mar 13, 1987
SCHULTZ PHALANGEAL COMPONENT DRIVER
K870847 · HWR
Warsaw Orthopedic, Inc.
Orthopedic · 10d
Cleared Mar 13, 1987
SCHULTZ METACARPAL COMPONENT DRIVER
K870848 · HWR
Warsaw Orthopedic, Inc.
Orthopedic · 10d
Cleared Mar 13, 1987
ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER
K870964 · IYO
Elscint, Inc.
Radiology · 3d
Cleared Mar 12, 1987
BENZODIAZEPINE ENZYME IMMUNOASSAY KIT
K863877 · JXM
General Diagnostics
Toxicology · 157d
Cleared Mar 12, 1987
RICKETTSIAL IGG AND IGM IFA KIT
K864110 · GPN
Hillcrest Biologicals
Microbiology · 142d
Cleared Mar 12, 1987
APO B., IMMUNOTURBIDIMETRIC ASSAY
K864228 · MSJ
Intl. Diagnostic Laboratories, Ltd.
Immunology · 135d
Cleared Mar 12, 1987
BECKMAN EPSILON(TM) LIPASE TEST KIT
K864438 · CET
Beckman Instruments, Inc.
Chemistry · 120d
Cleared Mar 12, 1987
MODIFIED IMAGEN(TM) CHLAMYDIA TEST
K864539 · LJP
Boots-Celltech Diagnostics, Inc.
Microbiology · 113d
Cleared Mar 12, 1987
IQ FREE T4 IMMUNOASSAY
K864658 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 104d
Cleared Mar 12, 1987
ANA TEST KIT
K864668 · LKJ
Val Tech Diagnostics, Inc.
Immunology · 100d
Cleared Mar 12, 1987
INFRALUX HEAT LAMP
K864714 · ILY
Infralux International, Inc.
Physical Medicine · 99d
Cleared Mar 12, 1987
NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 340
K864737 · DXN
Siemens Medical Solutions USA, Inc.
Cardiovascular · 98d
Cleared Mar 12, 1987
SOUNDTEK MODEL UT-4700
K864766 · IMJ
Soundtek, Inc.
Physical Medicine · 97d
Cleared Mar 12, 1987
AFFINITY(TM) HTSH IMMUNIT(TM)
K865081 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 72d
Cleared Mar 12, 1987
AFFINITY(TM) SYSTEM
K865105 · JJE
Bd Becton Dickinson Vacutainer...
Chemistry · 72d
Cleared Mar 12, 1987
TOTAL/IGE THEOPHYLLINE CONTROL SERA
K870151 · JJX
3M Company
Immunology · 58d
Cleared Mar 12, 1987
FERRITIN MAB SOLID PHASE COMPONENT SYSTEM
K870570 · DBF
Bd Becton Dickinson Vacutainer...
Immunology · 30d
Cleared Mar 12, 1987
OXY-THERM
K870832 · IMD
M.D. Intl., Inc.
Physical Medicine · 9d
Cleared Mar 11, 1987
ERA-20
K853194 · DTE
Biotronik Sales, Inc.
Cardiovascular · 589d
Cleared Mar 11, 1987
AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL
K863630 · EBI
Austenal Dental, Inc.
Dental · 175d
Cleared Mar 11, 1987
TRACETS 2000/ELECTRODES
K863674 · DRX
Lectec Corp.
Cardiovascular · 173d