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
156313–156336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 30, 1983
SPORIDIDIN-D COLD STERILIZING/SOLUTION
K830722 · LIF
Sporicidin Intl.
Gastroenterology & Urology · 114d
Cleared Jun 30, 1983
PORT-A-CATH IMPLANTABLE CATH. SYS
K830730 · LJT
Pharmacia, Inc.
General Hospital · 114d
Cleared Jun 30, 1983
CUSTOM IN-THE-EAR HEARING AID
K830960 · ESD
Finetone Hearing Instruments
Ear, Nose, Throat · 97d
Cleared Jun 30, 1983
QUINIDINE REAGENT TEST KIT
K830963 · LBZ
Beckman Instruments, Inc.
Chemistry · 94d
Cleared Jun 30, 1983
HERPES SIMPLEX VIRUS TYPING REAGENTS
K830971 · GQL
Immulok, Inc.
Microbiology · 94d
Cleared Jun 30, 1983
SUN PHOTO-KERATOSCOPE
K831084 · HLQ
Nidek, Inc.
Ophthalmic · 87d