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

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176,076 results
152929–152952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 1984
NON-CORING NEEDLE
K841742 · FMI
Creative Care Systems, Inc.
General Hospital · 70d
Cleared Jul 06, 1984
LIEBEL-FLARSHEIM ACS 1000 CHEST X-RAY
K841756 · KPR
Syvron Corp.
Radiology · 70d
Cleared Jul 06, 1984
HEPARIN CAP, INJECTION CAP MALE LUER-
K841772 · FPA
Linton Biomed Corp.
General Hospital · 67d
Cleared Jul 06, 1984
CLINICAL ELECTRONIC THERMOMETER
K841780 · FLL
Fidelity Medical, Inc.
General Hospital · 67d
Cleared Jul 06, 1984
MARK5 ARTERIAL BLOOD GAS KIT
K841810 · FMF
Martell Medical Products, Inc.
General Hospital · 66d
Cleared Jul 06, 1984
CANNU-SKREEN-PRELIMINARY
K841831 · DKE
Biochemical Diagnostic, Inc.
Toxicology · 64d
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