Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
154321–154344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1984
WI-38 HUMAN LUNG CELLS
K834123 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
VERO CELLS
K834124 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
MRC-5 CELLS
K834126 · KIR
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 114d
Cleared Mar 22, 1984
PBS W/MG+2 & CA+2
K834136 · KIT
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 113d
Cleared Mar 22, 1984
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19
K834191 · KOA
Imm Enterprises , Ltd.
Gastroenterology & Urology · 122d
Cleared Mar 22, 1984
JAKOBI SURG. INSTRUMENTS #3 21/22/24
K834192 · KOA
Imm Enterprises , Ltd.
Gastroenterology & Urology · 122d
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