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
137545–137568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 23, 1987
REVISED LABELING FOR TDX CANNABINOIDS
K874488 · LDJ
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
REVISED LABELING FOR TDX BENZODIAZEPINES
K874489 · JXM
Abbott Laboratories
Toxicology · 24d
Cleared Nov 23, 1987
KAMBIN LAMINECTOMY FRAME
K874494 · LWG
Avec Scientific Design Corp.
General & Plastic Surgery · 21d
Cleared Nov 23, 1987
MICROTEK MINI-MAX DRILL SYSTEM
K874535 · DZI
Microtek Medical, Inc.
Dental · 20d
Cleared Nov 20, 1987
LUBRICATED CONDOM
K872504 · HIS
Royal American Industries, Inc.
Obstetrics & Gynecology · 149d
Cleared Nov 20, 1987
BINAX EQUATE STREP B
K872904 · GTZ
Binax, Inc.
Microbiology · 119d
Cleared Nov 20, 1987
CLEARFIL PHOTO BOND
K872959 · KLE
Kuraray Co.
Dental · 114d
Cleared Nov 20, 1987
TORAY ANTHRON ANGIOGRAPHIC CATHETERS
K872983 · DQR
Toray Industries (America), Inc.
Cardiovascular · 112d
Cleared Nov 20, 1987
PLATELET EXTRACT REAGENT
K873382 · GGW
Bio/Data Corp.
Hematology · 88d
Cleared Nov 20, 1987
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
K873384 · JJQ
Helena Laboratories
Hematology · 88d
Cleared Nov 20, 1987
PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT
K873545 · EHZ
Commercial Products & Engineering Co.
Dental · 80d
Cleared Nov 20, 1987
GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES
K873564 · LKT
Genetic Systems Corp.
Microbiology · 79d
Cleared Nov 20, 1987
ACRYLIC BASE DENTURE MATERIALS
K873738 · EBI
E&D Dental Manufacturing Co.
Dental · 66d
Cleared Nov 20, 1987
EXCALIBUR ELECTROSURGICAL UNIT 60-5200-001
K873809 · BWA
Zimmer Aspen Labs
General & Plastic Surgery · 63d
Cleared Nov 20, 1987
THE EXTRACTOR(TM)
K873932 · DKO
Molecular Biosystems, Inc.
Microbiology · 56d
Cleared Nov 20, 1987
NICOLET DISPOSABLE PRASS PROBE
K873964 · ETN
Nicolet Biomedical Instruments
Ear, Nose, Throat · 52d
Cleared Nov 20, 1987
LAKE WOUND CARE/TREATMENT KIT
K873973 · LRO
Lake Medical Products, Inc.
General & Plastic Surgery · 52d
Cleared Nov 20, 1987
AMPICILLIN/SULBACTAM 10/10 MCG SUSCEPTIBILITY DISK
K874256 · JTN
Organon Teknika Corp.
Microbiology · 31d
Cleared Nov 20, 1987
REVISED LABELING FOR CANNABINOIDS TEST KIT
K874269 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 31d
Cleared Nov 20, 1987
PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL
K874304 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 31d
Cleared Nov 20, 1987
MODEL A-70, BEHIND-THE-EAR HEARING AID
K874323 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 30d
Cleared Nov 20, 1987
TX-2(TENS)
K874333 · GZJ
Oms Medico, Inc.
Neurology · 29d
Cleared Nov 20, 1987
CIPROFLOXACIN 5 MCG SENSI-DISC
K874425 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 23d
Cleared Nov 20, 1987
SOFT TISSUE ANCHORING SET KIT
K874439 · LRO
Concept, Inc.
General & Plastic Surgery · 23d