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
157153–157176 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 06, 1983
GLUCOSE HEXOKINASE DIAG. KIT
K831560 · CFR
Sclavo, Inc.
Chemistry · 51d
Cleared Jul 06, 1983
GLUCOSE REAGENT KITS-B6370-10A
K831624 · CGA
American Scientific Products
Chemistry · 47d
Cleared Jul 06, 1983
CREATININE REAGENTS B6360-10
K831627 · CGX
American Scientific Products
Chemistry · 47d
Cleared Jul 06, 1983
CREATININE REAGENTS B6370-13
K831628 · CGX
American Scientific Products
Chemistry · 47d
Cleared Jul 06, 1983
MRC-5 CELLS
K831679 · KIR
Viromed Laboratories, Inc.
Pathology · 43d
Cleared Jul 06, 1983
VERO CELLS
K831680 · KIR
Viromed Laboratories, Inc.
Pathology · 43d
Cleared Jul 06, 1983
HEP-2 CELLS
K831681 · KIR
Viromed Laboratories, Inc.
Pathology · 43d
Cleared Jul 06, 1983
MCCOY CELLS
K831682 · KIR
Viromed Laboratories, Inc.
Pathology · 43d
Cleared Jul 06, 1983
SF CELLS
K831683 · KIR
Viromed Laboratories, Inc.
Pathology · 43d
Cleared Jul 06, 1983
CYNOMOLGUS MONKEY KIDNEY CELLS SV5
K831684 · KIR
Viromed Laboratories, Inc.
Pathology · 43d
Cleared Jul 06, 1983
SF REFEEDING MEDIA
K831685 · KIT
Viromed Laboratories, Inc.
Pathology · 43d
Cleared Jul 06, 1983
TECHNICON H6000 SYSTEM CONTROL
K831704 · JPK
Technicon Instruments Corp.
Hematology · 41d
Cleared Jul 06, 1983
AC-22 AUTOCLAVE TAPE
K831722 · JOJ
Armak Tape Division
General Hospital · 36d
Cleared Jul 06, 1983
PENTOBARBITAL TOXICOLOGY CONTROL
K831739 · LAS
Utak Laboratories, Inc.
Toxicology · 36d
Cleared Jul 06, 1983
DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE
K831740 · DIF
Utak Laboratories, Inc.
Toxicology · 36d
Cleared Jul 06, 1983
BASAL MEDIUM EAGLE W/EARLES SALTS, &
K831745 · KIT
Sigma Chemical Co.
Pathology · 35d
Cleared Jul 06, 1983
MA600-IMPEDANCE AUDIOMETER
K831755 · ETY
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 35d
Cleared Jun 30, 1983
CARDIOTOMY FILTER
K830634 · JOD
Texas Medical Products, Inc.
Cardiovascular · 121d