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
140209–140232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 1987
DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM)
K870496 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
BGJB MED(FITTON JACKSON MOD)W/L-GLUT/W/O SOD BICAR
K870497 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
ISCOVE MOD DULBECCO MED HYBRI-MAX, PRODUCT# I2510
K870498 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
MCCOY 5A MED (MOD) SUUSPENSION CULTURE, M6523
K870499 · KIT
Sigma Chemical Co.
Pathology · 55d
Cleared Mar 30, 1987
F-12 MEDIUM, COON'S MODIFICATION PRODUCT NO. F6636
K870529 · KIT
Sigma Chemical Co.
Pathology · 52d
Cleared Mar 30, 1987
MEDIUM 199 WITH EARLE'S SALTS PRODUCT NO. M2520
K870530 · KIT
Sigma Chemical Co.
Pathology · 52d
Cleared Mar 30, 1987
VAN-TEC PUMPING SYSTEM
K870557 · KOD
Van-Tec, Inc.
Gastroenterology & Urology · 48d
Cleared Mar 30, 1987
T4013 TSB 5ML
K870592 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 48d
Cleared Mar 30, 1987
T9000 TSB 10ML
K870593 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 48d
Cleared Mar 30, 1987
T9802 TSB W/6.5% NACL
K870594 · JSD
Lakewood Biochemical Co., Inc.
Microbiology · 48d
Cleared Mar 30, 1987
T4012 TSB 2ML
K870595 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 48d
Cleared Mar 30, 1987
VAN-TEC MODULAR FLEXIBLE CYSTOURETHROSCOPE
K870679 · FBO
Van-Tec, Inc.
Gastroenterology & Urology · 39d
Cleared Mar 30, 1987
VAN-TEC SEGURA STONE BASKET W/PROTECTIVE SHEATH
K870696 · FFL
Van-Tec, Inc.
Gastroenterology & Urology · 39d
Cleared Mar 30, 1987
COSMOS
K870856 · IYB
Pausch Corp.
Radiology · 27d
Cleared Mar 30, 1987
TISSUE CULTURE BAG
K870865 · KJA
American Fluoroseal Corp.
Pathology · 27d
Cleared Mar 30, 1987
CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500
K870906 · EFW
Cost Rite Health Products, Inc.
Dental · 25d
Cleared Mar 30, 1987
HEARING AID
K870982 · ESD
Audioear Electronics
Ear, Nose, Throat · 20d
Cleared Mar 30, 1987
3M INSTANT FIT CUSTOM EARMOLD
K870985 · ESD
3M Company
Ear, Nose, Throat · 19d
Cleared Mar 30, 1987
PRICE'S ACID-FAST STAIN
K870988 · JTS
Devetec, Inc.
Pathology · 19d
Cleared Mar 27, 1987
CAPILLARY FLOW HOLLOW FIBER DIALYZERS
K863044 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 228d
Cleared Mar 27, 1987
BIOPSY NEEDLE GUIDE ATTACHMENT
K863797 · HGL
Elscint, Inc.
Obstetrics & Gynecology · 179d
Cleared Mar 27, 1987
280SL IMAGING SYSTEM TRANVAGINAL PROBES
K864151 · HGL
Ge Medical Systems Information...
Obstetrics & Gynecology · 155d
Cleared Mar 27, 1987
TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE
K864219 · HGL
Amedic USA
Obstetrics & Gynecology · 150d
Cleared Mar 27, 1987
MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR
K864261 · BZQ
Bio-Dyne, Inc.
Anesthesiology · 149d