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
173137–173160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 1977
BLOOD COLLECTION TUBE, BLUE
K771054 · GIM
Sherwood Medical Industries
Chemistry · 16d
Cleared Jun 29, 1977
BLOOD COLLECTION TUBE, RED
K771055 · GIM
Sherwood Medical Industries
Chemistry · 16d
Cleared Jun 29, 1977
BLOOD COLLECTION TUBE, GREEN
K771056 · GIM
Sherwood Medical Industries
Chemistry · 16d
Cleared Jun 28, 1977
POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE
K770826 · FON
Howmedica Corp.
Gastroenterology & Urology · 54d
Cleared Jun 28, 1977
TINNITUS AID, MODEL S244
K770938 · KLW
Vicon Instrument Co.
Ear, Nose, Throat · 36d
Cleared Jun 27, 1977
AQUEOUS PH/BLOOD GAS CONTROLS
K770228 · JJS
Instrumentation Laboratory CO
Chemistry · 140d
Cleared Jun 27, 1977
REAGENT SYSTEM
K770504 · JGZ
American Monitor Corp.
Chemistry · 103d
Cleared Jun 27, 1977
CALCULATOR, ENZYME, TURNER
K770671 · JQP
Turner Assoc.
Chemistry · 80d
Cleared Jun 27, 1977
MARKERS, STAINLESS STEEL
K770802 · KPK
Cardio-Surgical, Inc.
Cardiovascular · 62d
Cleared Jun 27, 1977
BLACK LAMPS,F72T12/BL/HO
K770862 · FTC
Dermatron Corp.
General & Plastic Surgery · 48d
Cleared Jun 27, 1977
CATHETER, POLYURETHANE, W/STYLET
K770868 · DQO
Abbott Laboratories
Cardiovascular · 46d
Cleared Jun 27, 1977
MEDISHIELD JORDON LIFTING FRAME
K770911 · FPP
Fraser Sweatman, Inc.
General Hospital · 39d
Cleared Jun 27, 1977
AEROSOL MASK
K770995 · BYG
Ohio Medical Products
Anesthesiology · 26d
Cleared Jun 27, 1977
FLEXION MITTENS
K771030 · IOD
Stat Medical Corp.
Physical Medicine · 18d
Cleared Jun 27, 1977
STROKE SLING
K771031 · ILI
Stat Medical Corp.
Physical Medicine · 18d
Cleared Jun 27, 1977
THERMOMETER, SINGLE USE, STRIP, TEMPADOT
K771037 · FQZ
Info-Chem
General Hospital · 17d
Cleared Jun 27, 1977
THERMOMETER, SINGLE USE, STRIP, TEMPADOT
K771038 · FQZ
Organon, Inc.
General Hospital · 17d
Cleared Jun 27, 1977
QUANTA-MATE VITAMIN B-12/FOLATE RA
K771047 · CDD
Bio-Rad
Immunology · 17d
Cleared Jun 27, 1977
BLOOD COLLECTION TUBE, LAVENDER
K771052 · GIM
Sherwood Medical Industries
Chemistry · 14d
Cleared Jun 27, 1977
INSERTEO, META.-PHAL.&THUMB CARPO-META
K771072 · HXO
Depuy, Inc.
Orthopedic · 13d
Cleared Jun 27, 1977
PHADEBAS T3 U TEST
K771078 · KHQ
Pharmacia, Inc.
Immunology · 12d
Cleared Jun 27, 1977
ORTHOPEDIC SOFT GOODS
K771109 · HSS
Orthopedic Systems, Inc.
Physical Medicine · 7d
Cleared Jun 24, 1977
CUSHIONS, DENTURE ADHESIVE, ALL-DAY
K770413 · EHS
Combe, Inc.
Dental · 112d
Cleared Jun 24, 1977
DETECTOR, UV, MOLEL GC-55
K770638 · KIE
Peokin-Elmer Corp.
Toxicology · 81d