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
128425–128448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 01, 1989
LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE
K893766 · MAJ
Abbott Laboratories
General Hospital · 166d
Cleared Nov 01, 1989
NANOS
K894239 · DXY
Biotronik Cardiac Pacemakers
Cardiovascular · 134d
Cleared Nov 01, 1989
DATASCOPE STEERING HANDLE
K894940 · DQX
Datascope Corp.
Cardiovascular · 90d
Cleared Nov 01, 1989
WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR
K894970 · DTZ
Minntech Corp.
Cardiovascular · 86d
Cleared Nov 01, 1989
PIK POCKET(R), MODEL PP-3
K895259 · EFS
Teledyne Water Pik
Dental · 152d
Cleared Nov 01, 1989
FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE
K895320 · LLZ
Digivision, Inc.
Radiology · 64d
Cleared Nov 01, 1989
MADAYAG, MANGHINI, FRANSEEN, GREEN, TROCAR NEEDLES
K895457 · KNW
Advance Medical Designs, Inc.
Gastroenterology & Urology · 57d
Cleared Nov 01, 1989
2018 ARTERIAL/VENOUS PRESSURE DRESSING
K895845 · NAD
Advance Medical Designs, Inc.
General & Plastic Surgery · 29d
Cleared Oct 31, 1989
FATIGMETER
K883914 · GWE
K. Jimbo Co., Inc.
Neurology · 410d
Cleared Oct 31, 1989
HEDY PATIENT EXAMINATION GLOVES (VINYL)
K891670 · LYZ
Hedd Industry Corp.
General Hospital · 225d
Cleared Oct 31, 1989
DISPOSABLE LATEX EXAMINATION GLOVES
K891794 · LYY
Cn Asia Sdn Bhd
General Hospital · 222d
Cleared Oct 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892138 · LYY
Shanghai Latex Factory
General Hospital · 210d
Cleared Oct 31, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892163 · LYY
Canada Packers, Inc.
General Hospital · 207d
Cleared Oct 31, 1989
OSMOMETER STANDARD SOLUTIONS
K892329 · JIT
D.R.G. Scientific Industries
Chemistry · 209d
Cleared Oct 31, 1989
PATIENT EXAMINATION GLOVES
K892769 · LYY
Glw Intl. Corp.
General Hospital · 203d
Cleared Oct 31, 1989
PULSATILE PUMP FOR GONADORELIN ACETATE
K893488 · FRN
Ortho Pharmaceutical Corp.
General Hospital · 180d
Cleared Oct 31, 1989
CEDIA CORTISOL ASSAY
K893954 · JFT
Microgenics Corp.
Chemistry · 152d
Cleared Oct 31, 1989
DOUBLE ANTIBODY GLUCAGON
K893975 · JME
Diagnostic Products Corp.
Chemistry · 151d
Cleared Oct 31, 1989
EOS CHEMISTRY ANALYZER
K894035 · JGS
Eos Technology Corp.
Chemistry · 147d
Cleared Oct 31, 1989
ABBOTT TDX TOTAL T3 PLUS
K894238 · CDP
Abbott Laboratories
Chemistry · 132d
Cleared Oct 31, 1989
STERILE SURGEONS GLOVES
K894256 · KGO
Chung Shiang Rubber Industrial Co.
General Hospital · 133d
Cleared Oct 31, 1989
RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT
K894315 · KLE
Lee Pharmaceuticals
Dental · 109d
Cleared Oct 31, 1989
PATIENT EXAMINATION GLOVES
K894449 · LYY
Pascorp Newmarket Sdn. Bhd.
General Hospital · 141d
Cleared Oct 31, 1989
DIATHRON(R) DIATHERMY UNIT
K894513 · HJM
Intl. Ophthalmic Industries Corp.
Ophthalmic · 104d