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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
119761–119784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 23, 1991
IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION
K913393 · DTB
Oscor Medical Corp.
Cardiovascular · 77d
Cleared Sep 23, 1991
MECHANICAL SHAPE SENSOR
K913510 · JFC
Pin Dot Products, Inc.
Physical Medicine · 47d
Cleared Sep 23, 1991
3 PORT ADAPTER
K913627 · FPA
Baxter Healthcare Corp
General Hospital · 39d
Cleared Sep 23, 1991
QTEST INFLUENZA A
K913828 · GNT
Bd Becton Dickinson Vacutainer...
Microbiology · 28d
Cleared Sep 23, 1991
UC312, ULTRA MINIATURE ITC HEARING AID
K914017 · ESD
Qualitone
Ear, Nose, Throat · 14d
Cleared Sep 20, 1991
GALIX MODEL MA-6R HOLTER REEL-TO-REEL RECORDER
K904176 · DSH
Galix Instrumentacion Biomedica
Cardiovascular · 374d
Cleared Sep 20, 1991
GALIX MA-6C HOLTER CASSETTE RECORDER
K904177 · DSH
Galix Instrumentacion Biomedica
Cardiovascular · 374d
Cleared Sep 20, 1991
CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER
K912777 · DQY
Cordis Corp.
Cardiovascular · 88d
Cleared Sep 20, 1991
LM-100/200LOW FLOW INSUFFLATOR
K912789 · HIG
Leisegang Medical, Inc.
Obstetrics & Gynecology · 87d
Cleared Sep 19, 1991
FURUI SHUNT, 2-WAY AND 3-WAY
K910004 · DWF
Theramed, Inc.
Cardiovascular · 260d
Cleared Sep 19, 1991
XIMATRON/CT OPTION
K910647 · KPQ
Fischer Imaging Corp.
Radiology · 218d
Cleared Sep 19, 1991
TROCAR (FALLER STYLET)
K910786 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 206d
Cleared Sep 19, 1991
COLLIMASTER-90
K911127 · IZW
Varian Assoc., Inc.
Radiology · 189d
Cleared Sep 19, 1991
SUCTION/IRRIGATION TUBE & TUBE WITH CHANNEL
K911312 · GEI
Northgate Technologies, Inc.
General & Plastic Surgery · 178d
Cleared Sep 19, 1991
NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)
K911399 · DZD
Aequitron Medical, Inc.
Dental · 174d
Cleared Sep 19, 1991
NGM GAS MODULE
K911647 · CBQ
Datex Division Instrumentarium Corp.
Anesthesiology · 157d
Cleared Sep 19, 1991
CODMAN SKULL PINS (ADULT & CHILD), REUSABLE
K912005 · HBL
Codman & Shurtleff, Inc.
Neurology · 136d
Cleared Sep 19, 1991
ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS
K912087 · JPA
Instrumentation Laboratory CO
Hematology · 129d
Cleared Sep 19, 1991
AUTO SUTURE ENDOSCOPIC FASCIA STAPLER
K912097 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 129d
Cleared Sep 19, 1991
FLOOR MOUNT TUBESTAND-PERFORMER-N 6610.102/S-9110
K912515 · KPR
Continental X-Ray Corp.
Radiology · 105d
Cleared Sep 19, 1991
FLOOR MOUNT TUBESTAND PERFORMER, 6610.101/S-9109
K912517 · KPR
Continental X-Ray Corp.
Radiology · 105d
Cleared Sep 19, 1991
SURGICAL GOWN
K912790 · FYE
Unicor Federal Dept. of Justice
General & Plastic Surgery · 86d
Cleared Sep 19, 1991
AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE
K912927 · GCJ
Intl. Medical, Inc.
General & Plastic Surgery · 78d
Cleared Sep 19, 1991
MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM
K912974 · IZH
Elscint, Inc.
Radiology · 73d