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
120649–120672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1991
SOFTTOUCH(R) GUIDING CATHETER
K912199 · DQY
Mallinckrodt Medical
Cardiovascular · 74d
Cleared Jul 30, 1991
STRYKER ECLIPSE WARMING STRETCHER
K912237 · DWI
Stryker Medical
General & Plastic Surgery · 70d
Cleared Jul 30, 1991
DISTAT ANTI-SCL-70 KIT
K912291 · LKJ
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared Jul 30, 1991
DIASTAT ANTI-JO-1 KIT
K912292 · DHN
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared Jul 30, 1991
MEDIKEEPER
K912346 · BRY
Medikeeper, Inc.
Anesthesiology · 63d
Cleared Jul 30, 1991
VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112
K912423 · LJT
Med Institute, Inc.
General Hospital · 60d
Cleared Jul 30, 1991
VITAL-PORT VASCULAR ACCESS SYSTEM 7010 AND 7110
K912424 · LJT
Med Institute, Inc.
General Hospital · 60d
Cleared Jul 30, 1991
SALTER LABS INFANT NASAL CPAP CANNULA
K912434 · BZD
Salter Labs
Anesthesiology · 57d
Cleared Jul 30, 1991
VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121
K912465 · LJT
Med Institute, Inc.
General Hospital · 56d
Cleared Jul 30, 1991
IONOSEAL
K912495 · EJK
Voco GmbH
Dental · 55d
Cleared Jul 30, 1991
IONOBOND
K912497 · EMA
Voco GmbH
Dental · 55d
Cleared Jul 30, 1991
K-FREE
K912587 · LDD
Katecho, Inc.
Cardiovascular · 48d
Cleared Jul 30, 1991
MECONIUM ASPIRATION
K912596 · BSY
Pacific Device, Inc.
Anesthesiology · 50d
Cleared Jul 30, 1991
REP ALP-15, 8, & 4 KITS
K912603 · CIN
Helena Laboratories
Chemistry · 50d
Cleared Jul 30, 1991
TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL
K912725 · JJY
Creative Laboratory Products, Inc.
Chemistry · 40d
Cleared Jul 30, 1991
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
K912808 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 30, 1991
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
K912810 · CEK
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jul 30, 1991
BACTI-SWAB(TM) II
K912831 · LIO
Remel Co.
Microbiology · 34d
Cleared Jul 30, 1991
LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY
K912858 · CFL
London Diagnostics, Inc.
Chemistry · 32d
Cleared Jul 30, 1991
SYNERMED SERUM IRON-600 REAGENT KIT
K912912 · CFM
Synermed, Inc.
Chemistry · 27d
Cleared Jul 30, 1991
MILENIA ESTRADIOL
K912917 · CHP
Diagnostic Products Corp.
Chemistry · 27d
Cleared Jul 30, 1991
RHYTHM
K912938 · GWS
Stellate Systems
Neurology · 25d
Cleared Jul 30, 1991
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS
K913066 · KLT
Syva Co.
Toxicology · 20d
Cleared Jul 29, 1991
INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE
K903962 · LRP
Apk Technology
General & Plastic Surgery · 335d