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
124177–124200 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1990
OSTEOTOMES OF VARIOUS TYPES
K901521 · LXH
Mumtaz I. Malik
Physical Medicine · 179d
Cleared Sep 28, 1990
MULTI-DRUG INFUSION SYSTEM
K901978 · FRN
I-Flow Corp.
General Hospital · 149d
Cleared Sep 28, 1990
O. B. PACK IV
K902032 · HFC
Customed, Inc.
Obstetrics & Gynecology · 147d
Cleared Sep 28, 1990
SURGICAL TOWEL
K902715 · KKX
Aztec Medical, Inc.
General Hospital · 100d
Cleared Sep 28, 1990
SOFTOUCH GUIDING CATHETER
K902953 · DQO
Mallinckrodt Medical
Cardiovascular · 85d
Cleared Sep 28, 1990
BEAMER 1,2,4,6, AND 8
K903724 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 43d
Cleared Sep 27, 1990
PARTNER VOLUME MONITOR
K901885 · BZK
Bird Products Corp.
Anesthesiology · 154d
Cleared Sep 27, 1990
ROADRUNNER WIRE GUIDE
K901899 · DQX
Cook, Inc.
Cardiovascular · 153d
Cleared Sep 27, 1990
RESUBMITTED MULTIORGAN PERFUSION CANNULA
K902394 · DWF
Fresenius USA, Inc.
Cardiovascular · 120d
Cleared Sep 27, 1990
MODIFIED HEARTSTART DEFIBRILLATION ELECTRODE
K902429 · LDD
Laerdal Mfg. Corp.
Cardiovascular · 128d
Cleared Sep 27, 1990
JOINT MOTON IMAGER(TM)
K902583 · JAA
Concord Imaging, Ltd.
Radiology · 107d
Cleared Sep 27, 1990
RADIOPAQUE RULER
K902606 · KPR
Professional Medical Services
Radiology · 107d
Cleared Sep 27, 1990
MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA
K902779 · DQA
S & W Medico Teknik
Anesthesiology · 113d
Cleared Sep 27, 1990
BARD FILTERED CARDIOTOMY RESERVOIR
K902856 · DTP
C.R. Bard, Inc.
Cardiovascular · 90d
Cleared Sep 27, 1990
INTELECT 170
K902860 · IMG
Chattanooga Group, Inc.
Physical Medicine · 90d
Cleared Sep 27, 1990
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE*
K902872 · GAW
United States Surgical, A Division of...
General & Plastic Surgery · 90d
Cleared Sep 27, 1990
NONABSORBABLE DACRON SURGICAL SUTURE*
K902873 · GAS
United States Surgical, A Division of...
General & Plastic Surgery · 90d
Cleared Sep 27, 1990
INTELECT 750 MP
K902875 · IMG
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Sep 27, 1990
ROCHE COBAS READY HDL CHOLESTEROL REAGENT
K902935 · JHM
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Sep 27, 1990
KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN
K903071 · JJE
Eastman Kodak Company
Chemistry · 77d
Cleared Sep 27, 1990
SITERITE NEEDLE GUIDE
K903158 · DQY
Dymax Corp
Cardiovascular · 71d
Cleared Sep 27, 1990
COULOCHEM II
K903231 · LEQ
Esa, Inc.
Toxicology · 66d
Cleared Sep 27, 1990
TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD
K903305 · KHS
Technicon Instruments Corp.
Chemistry · 65d
Cleared Sep 27, 1990
SYVA(R) ETS(R) PLUS SYSTEM
K903357 · JJF
Syva Co.
Chemistry · 63d