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
157129–157152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 1983
ELECTROPHORESIS CONTROLS-3 IN 1
K831263 · JJY
Corning Medical & Scientific
Chemistry · 80d
Cleared Jul 07, 1983
GUM MACHINE
K831321 · EFS
The Gum Machine Co.
Dental · 76d
Cleared Jul 07, 1983
SALICYLATE ASSAY KIT
K831336 · DKJ
Quantimetrix Corp.
Chemistry · 73d
Cleared Jul 07, 1983
RESTROSPECTIVE ECG MEMORY MODULE
K831406
Cardiac Evaluation Center, Inc.
Cardiovascular · 66d
Cleared Jul 07, 1983
CYPRANE TEC 4 CONTINUOUS FLOW VAPOR.
K831427 · CAD
Fraser Harlake, Inc.
Anesthesiology · 65d
Cleared Jul 07, 1983
LEATHER VALVE CUTTER
K831455 · DWS
American V. Mueller
Cardiovascular · 62d
Cleared Jul 07, 1983
TRACHEOSTOMY TUBE
K831511 · BTO
Implant Technology, Inc.
Anesthesiology · 56d
Cleared Jul 07, 1983
AMYLAST-D TEST
K831561 · JFJ
Sclavo, Inc.
Chemistry · 52d
Cleared Jul 07, 1983
TRACHEA/CUFF INFLATOR W/PRESSURE #583
K831577 · BSK
Medical Electronics Corp.
Anesthesiology · 51d
Cleared Jul 07, 1983
TITAN GE/IEPLATE
K831603 · JZR
Helena Laboratories
Chemistry · 50d
Cleared Jul 07, 1983
UREA NITROGEN-BUN-REAGENTS B6360-12
K831625 · CDQ
American Scientific Products
Chemistry · 48d
Cleared Jul 07, 1983
UREA NITROGEN-BUN-REAGENTS B6370-11A
K831626 · CDQ
American Scientific Products
Chemistry · 48d
Cleared Jul 07, 1983
ACU-PUNCH
K831635
Acuderm, Inc.
Pathology · 48d
Cleared Jul 07, 1983
CHLAMYDIA OVERBY MEDIA
K831686 · KIT
Viromed Laboratories, Inc.
Pathology · 44d
Cleared Jul 07, 1983
SURGICAL DRILL BITS
K831712 · HTW
Medical Specialists IN Packaging
Orthopedic · 41d
Cleared Jul 07, 1983
NON CONDUCTIVE ANESTHESIA FACEMASK
K831713 · BSJ
Vital Signs, Inc.
Anesthesiology · 41d
Cleared Jul 07, 1983
MICRO-AIRE REPLACEMENT SURG. SAW BLADE
K831714 · GFA
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 41d
Cleared Jul 07, 1983
NEUROTRAC
K831715 · ETN
Hdc Corp.
Ear, Nose, Throat · 41d
Cleared Jul 07, 1983
ARGYLE SILICONE TRACHESTOMY TUBE W/LOW
K831720 · BTO
Sherwood Medical Co.
Anesthesiology · 37d
Cleared Jul 07, 1983
RIONET HEARING AID -AND/OR RION
K831721 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 37d
Cleared Jul 07, 1983
MA 610-IMPEDANCE AUDIOMETER
K831754 · ETY
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 36d
Cleared Jul 07, 1983
ARTIFICIAL KIDNEY BLOOD CIRCUIT
K831770 · KOC
Eiken Kizai Co., Ltd.
Gastroenterology & Urology · 35d
Cleared Jul 07, 1983
GUILLOTINE BLADE
K831772 · HTZ
Ortho Pared Instruments, Inc.
General & Plastic Surgery · 35d
Cleared Jul 07, 1983
HEMOCLAV VENOUS CATHETER
K831801 · FIQ
Exo, Inc.
Gastroenterology & Urology · 34d