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
153481–153504 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1984
BILIARY INDWELLING STENT
K834351 · FGE
Hobbs Medical, Inc.
Gastroenterology & Urology · 100d
Cleared Mar 22, 1984
URETERAL DOUBLE PIGTAIL STENT
K834401 · FAD
Hobbs Medical, Inc.
Gastroenterology & Urology · 99d
Cleared Mar 22, 1984
WEE BAG O'MERCURY
K840004 · LCC
Surgi-Quip Inc.U
Ophthalmic · 78d
Cleared Mar 22, 1984
DIGITAL PROCESSING SYSTEM
K840052 · IYX
Adac Laboratories
Radiology · 76d
Cleared Mar 22, 1984
BSM 2000 DIALYSIS MACHINE
K840062 · KOC
Organon Teknika Corp.
Gastroenterology & Urology · 73d
Cleared Mar 22, 1984
SPEECH TEACHER
K840112 · ILP
Joseph A. Resnick
Physical Medicine · 73d
Cleared Mar 22, 1984
DESERET INFANT CENTRAL VENOUS CATHE-
K840116 · FOZ
Parke-Davis Co.
General Hospital · 71d
Cleared Mar 22, 1984
EKTACHEM CLINICAL CHEM. SLIDES
K840151 · CED
Eastman Kodak Company
Chemistry · 69d
Cleared Mar 22, 1984
EMIT ST URINE METHAQUALONE ASSAY
K840164 · KXS
Syva Co.
Toxicology · 66d
Cleared Mar 22, 1984
EMIT ST SERUM PHENCYCLIDINE ASSAY
K840199 · LCM
Syva Co.
Toxicology · 63d
Cleared Mar 22, 1984
C-ARM CEILING CRANE FT-2
K840225 · JAA
Medicor USA , Ltd.
Radiology · 63d
Cleared Mar 22, 1984
DISPOSABLE CUVETTE ARRAY
K840231 · JJG
Consumable Lab Supplies
Chemistry · 62d
Cleared Mar 22, 1984
SERENITY CONTOURED ABSORBENT SHIELDS
K840679 · EYQ
Johnson & Johnson Consumer Products,...
Gastroenterology & Urology · 36d
Cleared Mar 22, 1984
SECURE W/25MM DIAM. SHEATH & ADHESIVE
K840702 · KNX
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 34d
Cleared Mar 22, 1984
SECURE W/30MM DIAM, SHEATH & ADHESIVE
K840703 · KNX
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 34d
Cleared Mar 22, 1984
SECURE W/35MM DIAM, SHEATH/ADHESIVE
K840704 · KNX
Warne Surgical Products, Ltd.
Gastroenterology & Urology · 34d
Cleared Mar 22, 1984
NEEDLE CATHETER JEJUNOSTOMY REPAIR KIT
K840936 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 17d
Cleared Mar 21, 1984
3-DAY BIOINDICATOR RELEASE FOR STERIL
K833831 · BTR
Shiley, Inc.
Anesthesiology · 135d
Cleared Mar 20, 1984
PROBES, VARIOUS
K841003 · KOA
Premier Dental Products Co.
Gastroenterology & Urology · 11d
Cleared Mar 20, 1984
ALU-KART
K841178
Micro Encapsulation Tech.
Gastroenterology & Urology
Cleared Mar 20, 1984
HEMO-KART
K841179
Micro Encapsulation Tech.
Gastroenterology & Urology
Cleared Mar 20, 1984
DIA-KART
K841180
Micro Encapsulation Tech.
Gastroenterology & Urology
Cleared Mar 19, 1984
CM-VII PHYSIOLOGIC ANALYZER
K831586 · BZM
Cybermedic, Inc.
Anesthesiology · 307d
Cleared Mar 19, 1984
SERALYZER THEOPHYLLINE REAGENT STRIPS
K832825 · KLS
Miles Laboratories, Inc.
Toxicology · 213d