FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
130609–130632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1989
KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES
K892438 · FPA
The Kendal Co.
General Hospital · 105d
Cleared Jul 24, 1989
KENDALL CURITY EXTENSION TUBES
K892440 · FPA
The Kendal Co.
General Hospital · 105d
Cleared Jul 24, 1989
VINYL PATIENT EXAMINATION GLOVES
K892575 · LYZ
Foodhandler, Inc.
General Hospital · 105d
Cleared Jul 24, 1989
ENTERA-FLO SPIKE SET
K893209 · KNT
Delmed, Inc.
Gastroenterology & Urology · 88d
Cleared Jul 24, 1989
LATEX EXAMINATION GLOVES
K893295 · LYY
Lee AH Sheng Ent. Co., Ltd.
General Hospital · 97d
Cleared Jul 24, 1989
LATEX EXAMINATION GLOVES
K893296 · LYY
Midas Intl. Development Corp.
General Hospital · 97d
Cleared Jul 24, 1989
TWO TANK DISSOLUTION MODULE
K893612 · FKQ
National Medical Care, Medical...
Gastroenterology & Urology · 75d
Cleared Jul 24, 1989
HOLLOW FIBER DIALYZER FOCUS 70H
K893677 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 69d
Cleared Jul 24, 1989
SHUNT CONNECTORS
K893679 · FJQ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 69d
Cleared Jul 24, 1989
PERITONEAL DIALYSIS SYSTEM AND ACCESS.
K893712 · KDJ
Delmed, Inc.
Gastroenterology & Urology · 67d
Cleared Jul 24, 1989
FILTRAL TM 20 HEMODIALYZER/FILTER
K893742 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 68d
Cleared Jul 24, 1989
ML-800 AUTOELECTRONIC LIGHT SOURCE
K893828 · FST
M.P. Video, Inc.
General & Plastic Surgery · 61d
Cleared Jul 24, 1989
LATEX EXAMINATION GLOVES
K893864 · LYY
In Medicine, Inc.
General Hospital · 60d
Cleared Jul 24, 1989
THORACENTISIS KIT
K894326 · GAA
Mill-Rose Laboratory
General & Plastic Surgery · 10d
Cleared Jul 20, 1989
70-X/RVG (RADIOVISIOGRAPHY)
K881133 · EHO
Trophy Radiologie
Radiology · 491d
Cleared Jul 20, 1989
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K890194 · JOH
Shiley, Inc.
Anesthesiology · 184d
Cleared Jul 20, 1989
STAT CHEM SYSTEM
K891050 · CGA
Diagnostic Resources, Inc.
Chemistry · 142d
Cleared Jul 20, 1989
MINICLINIC OVULATION PREDICTION TEST
K891762 · CEP
Vanguard Biomedical Corp.
Chemistry · 118d
Cleared Jul 20, 1989
THE POUCH GROIN & ABDOMINAL STRESS AID
K892379 · FSD
Kuhn Industries
General Hospital · 105d
Cleared Jul 20, 1989
ACID PHOSPHATASE REAGENT
K892393 · CKB
Medical Analysis Systems, Inc.
Chemistry · 104d
Cleared Jul 20, 1989
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
K892410 · DXE
Baxter Healthcare Corp
Cardiovascular · 104d
Cleared Jul 20, 1989
CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE
K892500 · JGS
Ciba Corning Diagnostics Corp.
Chemistry · 98d
Cleared Jul 20, 1989
TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS
K892668 · CIG
Catachem, Inc.
Chemistry · 98d
Cleared Jul 20, 1989
SOFTWARE RELEASE 1.3 FOR THE SL SERIES LINEAR ACCE
K892845 · IYE
Philips Medical Systems, Inc.
Radiology · 93d