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
174289–174312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 1977
FLUORESCEIN CONJUGATED ANTISERUM
K770668 · DEW
Kent Laboratories, Inc.
Immunology · 20d
Cleared Apr 28, 1977
RHODAMINE-CONJUGATED ANTISERUM
K770669 · DEW
Kent Laboratories, Inc.
Immunology · 20d
Cleared Apr 28, 1977
FLOR. CONJUG. HUMAN FAB FRAGMENT
K770670 · DFK
Kent Laboratories, Inc.
Immunology · 20d
Cleared Apr 28, 1977
GAMBRO VENOUS BLOOD LINE
K770691 · KOC
Gambro, Inc.
Gastroenterology & Urology · 14d
Cleared Apr 28, 1977
MONITORS, REMOTE, RMS III
K770721 · CCK
The Perkin-Elmer Corp.
Anesthesiology · 10d
Cleared Apr 28, 1977
RIA KIT, T4 CLASP
K770726 · CDX
Squibb & Sons, Inc.
Immunology · 9d
Cleared Apr 28, 1977
INTRAOCULAR LENS
K770728
Milton Roy Co. Analytical
Ophthalmic · 8d
Cleared Apr 28, 1977
PYELOSCOPE SYSTEM
K770729 · FGA
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 8d
Cleared Apr 28, 1977
CUTTER CAST 7
K770742 · ITG
Cutter Laboratories, Inc.
Physical Medicine · 6d
Cleared Apr 28, 1977
DUODENOSCOPE, MOLEL TX-6
K770754 · FOG
American Cystocope Makers, Inc.
Anesthesiology · 3d
Cleared Apr 27, 1977
IN VITRO DIAGNOSTIC TEST
K770467
Hoffmann-La Roche, Inc.
Immunology · 48d
Cleared Apr 27, 1977
IMMUNOELECTROPHORESIS PROFILE KIT
K770566 · JZS
Kallestad Laboratories, Inc.
Immunology · 34d
Cleared Apr 27, 1977
PROBE, TEMPERATURE, SYSTEM, SARNS
K770709 · DRF
3M Health Care, Sarns
Cardiovascular · 9d
Cleared Apr 27, 1977
MONITOR, PATIENT, RESP. CARBON DIOXIDE
K770713 · CCK
Cavitron Corp.
Anesthesiology · 9d
Cleared Apr 27, 1977
CATHETER, ARTERIAL EMBOLECTOMY
K770714 · DXE
Mallinckrodt Critical Care
Cardiovascular · 9d
Cleared Apr 26, 1977
PROPANE, HIGH PURITY, INSTRUMENT GRADE
K770393 · JJO
Hycel, Inc.
Chemistry · 57d
Cleared Apr 26, 1977
REAGENT, AMYLASE LIPASE
K770400 · KHM
Bd Becton Dickinson Vacutainer...
Chemistry · 55d
Cleared Apr 26, 1977
LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE
K770401 · JJI
Bd Becton Dickinson Vacutainer...
Chemistry · 55d
Cleared Apr 26, 1977
BLOOD RESERVOIR
K770546 · DTN
Delta Medical Industries
Cardiovascular · 36d
Cleared Apr 26, 1977
CATHETER,PERCUTANEOUS INTRODUC. & SHEATH
K770561 · DYB
Usci, Div. C.R. Bard, Inc.
Cardiovascular · 34d
Cleared Apr 26, 1977
ECHOENCEPHALOGRAPH, DIGITAL, 1000
K770575 · GXW
Storz Instrument Co.
Neurology · 29d
Cleared Apr 26, 1977
GENERATOR, PULSE, CARDIAC 20U
K770656 · DXY
Edwards Pacemaker Systems
Cardiovascular · 19d
Cleared Apr 26, 1977
GENERATOR, PULSE, CARDIAC 2LU
K770657 · DXY
Edwards Pacemaker Systems
Cardiovascular · 19d
Cleared Apr 26, 1977
GENERATOR, PULSE, IMPLANTABLE
K770661 · DXY
Med Telectronics , Ltd.
Cardiovascular · 19d