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
132745–132768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1989
CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20
K884252 · KNS
Circon Acmi
Gastroenterology & Urology · 91d
Cleared Jan 10, 1989
APA-C CATALOG NUMBER A-8001-C
K884299 · IYO
Ausonics Pty , Ltd.
Radiology · 89d
Cleared Jan 10, 1989
ANGIOPUMP TUBING SET
K884310 · DWF
Olympus Corp.
Cardiovascular · 89d
Cleared Jan 10, 1989
MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER
K884331 · DTC
Medtronic Vascular
Cardiovascular · 88d
Cleared Jan 10, 1989
NORITAKE SUPER PORCELAIN EX-3
K884356 · EIH
Noritake Co., Inc.
Dental · 85d
Cleared Jan 10, 1989
EDENTEC MODEL 4700 SCANNER
K884388 · DSF
Edentec Corp.
Cardiovascular · 84d
Cleared Jan 10, 1989
HP 21362B TRANSESOPHAGEAL ULTRASOUND IMAGING TRANS
K884395 · IYO
Hewlett-Packard Co.
Radiology · 84d
Cleared Jan 10, 1989
CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE
K884481 · LIT
Mallinckroot, Inc.
Cardiovascular · 80d
Cleared Jan 10, 1989
BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED
K884515 · EKJ
Gatewood and Associates, Ltd.
Dental · 75d
Cleared Jan 10, 1989
HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES
K884590 · KFF
Hemotec, Inc.
Hematology · 68d
Cleared Jan 10, 1989
PLAYTEX NON-DEODORANT AND DEODORANT TAMPONS
K884737 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 57d
Cleared Jan 10, 1989
CONSED FECAL CONCENTRATION SYSTEM
K884755 · IFP
Donald L. Price, Ph.D.
Pathology · 57d
Cleared Jan 10, 1989
ATI-PYMAH DISPOSABLE BIOLOGICAL TEST PACK
K884767 · FRC
Pymah Corp., Ati Div.
General Hospital · 57d
Cleared Jan 10, 1989
OCUSHIELDS MASKS
K884877 · FXX
Dioptics
General Hospital · 50d
Cleared Jan 10, 1989
TAMPAX ULTRAFIT PANTY SHIELDS
K884950 · HHD
Tambrands, Inc.
Obstetrics & Gynecology · 46d
Cleared Jan 10, 1989
TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT
K884951 · HHL
Tambrands, Inc.
Obstetrics & Gynecology · 46d
Cleared Jan 10, 1989
DENTAL MIRROR RETRACTOR
K885040 · EKJ
Nu-Lite Retractor, Inc.
Dental · 36d
Cleared Jan 10, 1989
TIN COATED NITI ORTHODONTIC ARCH WIRES
K885086 · EJF
Flexmedics
Dental · 32d
Cleared Jan 10, 1989
BENDA BRUSH
K885162 · EKJ
Centrix, Inc.
Dental · 28d
Cleared Jan 10, 1989
LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEM
K885164 · HQF
Chiron Vision Corp.
Ophthalmic · 28d
Cleared Jan 10, 1989
(HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2
K885181 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 27d
Cleared Jan 10, 1989
ATS MAYER'S ALBUMIN
K890022 · KEL
Alpha-Tec Systems, Inc.
Pathology · 6d
Cleared Jan 09, 1989
RENALIN COLD STERILANT
K882564 · LRJ
Minntech Corp.
General Hospital · 202d
Cleared Jan 09, 1989
ADJUSTABLE ENTRAINMENT NEBULIZER
K882936 · CAF
Automatic Liquid Packaging, Inc.
Anesthesiology · 180d