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
156289–156312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 07, 1983
TEFLON FEMORAL CATHETER MWI 100,10 &
K831828 · LFK
Med-West, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 07, 1983
H-O CAMERA
K831832
Uni-Quatro Industries
General & Plastic Surgery · 30d
Cleared Jul 07, 1983
MX CAMERA
K831833
Uni-Quatro Industries
General & Plastic Surgery · 30d
Cleared Jul 07, 1983
SURGEON'S CHOICE CRUTCH HANDLE
K831889 · INP
W.K. Wheeler, Inc.
Physical Medicine · 23d
Cleared Jul 07, 1983
ENSWELL
K831899 · IME
Dr. Micheal A. Sabia
Physical Medicine · 23d
Cleared Jul 06, 1983
GLUCOSE OXIDASE/PEROXIDASE TEST
K831411 · CGA
King Diagnostics, Inc.
Microbiology · 65d