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
152089–152112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 1984
KODAK EKTACHEM CONTROL
K841884 · JJY
Eastman Kodak Company
Chemistry · 60d
Cleared Jul 06, 1984
MAXICAMERA 400 AC
K841906 · IYX
General Electric Co.
Radiology · 59d
Cleared Jul 06, 1984
BACTIGEN - N.MENNINIGITIDIS TEST
K841907 · GTJ
Armkel, LLC
Microbiology · 59d
Cleared Jul 06, 1984
DISPO. AES DISPOS. SYRINGE W/NEEDLE
K841931 · FMF
Hirsch Chemie , Ltd.
General Hospital · 56d
Cleared Jul 06, 1984
UMI CURVED CHEMONUCLEOLYSIS NEEDLE
K842012 · FMI
Universal Medical Instrument Corp.
General Hospital · 50d
Cleared Jul 06, 1984
SAWYER FIRST AID KIT
K842015 · KYP
Saffeta, Inc.
General Hospital · 49d
Cleared Jul 06, 1984
COOK PACEMAKER CORP. 115 UNIPOLAR CARDI
K842081 · DXY
Cook Pacemaker Corp.
Cardiovascular · 44d
Cleared Jul 06, 1984
SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY
K842134 · JGQ
Somas Medical Industries, Inc.
Chemistry · 37d
Cleared Jul 06, 1984
HI-LO FLOOR STANDING EXAM. LIGHT
K842135 · KZF
Good-Lite Co.
General Hospital · 37d
Cleared Jul 06, 1984
STERILE PAN SET
K842136 · FRG
Medi-Plast Intl., Inc.
General Hospital · 37d
Cleared Jul 06, 1984
ULTRA CHEM ENZYMATIC TRIGLYCERIDE
K842211 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 32d
Cleared Jul 06, 1984
RENATRON
K842258 · LIF
Renal Systems, Inc.
Gastroenterology & Urology · 29d
Cleared Jul 06, 1984
ALL-HANDS TRACHEOSTOMY CARE SET 0101
K842415 · BTO
All-Hands Medical Supply, Inc.
Anesthesiology · 16d
Cleared Jul 06, 1984
JET VENTILATION ADAPTOR
K842456
Portex, Inc.
Cardiovascular · 14d
Cleared Jul 06, 1984
TRACHEAL TUBE/STETHOSCOPE
K842464 · BTR
Mallinckrodt Critical Care
Anesthesiology · 11d
Cleared Jul 06, 1984
DRYDEN INFLATABLE MASK
K842472 · BSJ
Dryden Corp.
Anesthesiology · 11d
Cleared Jul 06, 1984
SAMSON'S NEWBORN LUNG INFLATOR 340-1000
K842487 · BTM
J. H. Emerson Co.
Anesthesiology · 10d
Cleared Jul 06, 1984
SAMSON 1000 ANESTHESIA CIRCUIT
K842488 · CAI
J. H. Emerson Co.
Anesthesiology · 10d
Cleared Jul 06, 1984
AMER. MEDICAL PLASTICS CO 20100
K842492 · CAI
American Medical Plastics Co.
Anesthesiology · 10d
Cleared Jul 03, 1984
CEMENTLESS HIP PROSTHESIS
K840271
Mecron Medical Products, Inc.
Orthopedic · 162d
Cleared Jul 03, 1984
MULTICHANNEL 2000 FLUOROPTIC THERMOMET
K841105 · FLL
Luxtron
General Hospital · 111d
Cleared Jul 03, 1984
DENTAL COTTON ROLLS
K841327 · EFN
Intl. Verbandstoff-Fabrik Schaffhau
Dental · 92d
Cleared Jul 03, 1984
RIGHT ANGLED PICK
K841355 · JYT
Treace Medical, Inc.
Ear, Nose, Throat · 92d
Cleared Jul 03, 1984
MODEL 3014 SUCTION UNIT
K841631 · HHI
Forma Scientific, Inc.
Obstetrics & Gynecology · 74d