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
172249–172272 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1978
QUALITY CONTROL SYSTEM, SPECTRA
K780097 · KSF
Bd Becton Dickinson Vacutainer...
Hematology · 95d
Cleared Apr 24, 1978
NORMAL UNASSAYED CONTROL SERA
K780351 · JJY
Macomb Chemical Co.
Hematology · 52d
Cleared Apr 24, 1978
THYRO-ZYME-T4 ASSAY KIT
K780401 · CDX
Coulter Electronics, Inc.
Chemistry · 42d
Cleared Apr 24, 1978
LOW IIONIC STRENGTH SOLUTION
K780413 · KSG
Pfizer, Inc.
Hematology · 40d
Cleared Apr 24, 1978
SGOT/AST REAGENT SYSTEM
K780443 · CIT
American Monitor Corp.
Chemistry · 35d
Cleared Apr 24, 1978
EMIT CARBAMAZEPINE ASSAY
K780466 · KLT
Syva Co.
Toxicology · 33d
Cleared Apr 24, 1978
EMIT ANTIEPILEPTIC DRUG CALIBRATORS
K780467 · JIS
Syva Co.
Toxicology · 33d
Cleared Apr 24, 1978
DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT
K780475 · DON
Burroughs Wellcome Co.
Toxicology · 31d
Cleared Apr 24, 1978
DISC-PAK ROTATOR
K780544 · GLE
Techhnilab Instruments, Inc.
Hematology · 21d
Cleared Apr 24, 1978
SPECT RIM (LISS)
K780556 · KSG
Bd Becton Dickinson Vacutainer...
Hematology · 19d
Cleared Apr 21, 1978
THERAPEUTIC APPARATUS, DIERKER TYPE
K770534 · KDH
Well Being Ent.
Gastroenterology & Urology · 396d
Cleared Apr 21, 1978
RATE PROGRAMMER MODEL 520
K780175 · KRG
Intermedics, Inc.
Cardiovascular · 77d
Cleared Apr 21, 1978
BLOOD FLOWMETER SYSTEM
K780302 · DPW
Medtronic Vascular
Cardiovascular · 58d
Cleared Apr 21, 1978
PANTRIDGE MK III DEFIBRILLATOR/MONITOR
K780416 · LDD
Ipco Corp.
Cardiovascular · 38d
Cleared Apr 21, 1978
ACTIVE-LIFE
K780454 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 32d
Cleared Apr 21, 1978
SNAP-FIT
K780511 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 22d
Cleared Apr 21, 1978
PERCUTANEOUS SHEATH INTRODUCER KIT
K780532 · DYB
Arrow Intl., Inc.
Cardiovascular · 17d
Cleared Apr 21, 1978
ELECTRIC RESPONSE AUDIOMETER
K780540 · GWJ
Life-Tech Instruments, Inc.
Neurology · 18d
Cleared Apr 21, 1978
DENTAL AMALGAMATOR
K780560 · EFD
L.D. Caulk Co.
Dental · 16d
Cleared Apr 21, 1978
HEALTH SEAT SYSTEM
K780566 · DXN
G & W Applied Science Laboratories
Cardiovascular · 15d
Cleared Apr 21, 1978
COLD PACK
K780603 · IMD
Abco Dealers, Inc.
Physical Medicine · 11d
Cleared Apr 21, 1978
DENTAL ROTARY CARBIDE BURS 76EJL
K780641 · EJL
Teledyne Densco
Dental · 4d
Cleared Apr 19, 1978
IMMUNOZYME E. HISTOLYTICA ANTIGENS
K780114
Millipore Corp.
Microbiology · 86d
Cleared Apr 19, 1978
HDL REAGENT SET FOR LIPOPROTEINS
K780389 · CHH
Worthington Biochemical Corp.
Chemistry · 40d