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
164305–164328 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1981
APPOSE SKIN STAPLER
K811030 · GAG
Davis & Geck, Inc.
General & Plastic Surgery · 41d
Cleared May 27, 1981
PENTAX BRONCHOFIBERSCOPE #FB-15A
K811059 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 40d
Cleared May 27, 1981
BYPASS COIL
K811068 · KPY
G.D. Searle and Co.
Radiology · 40d
Cleared May 27, 1981
INTERMEDICS POLY FLEX ENDOCARDIAL PACING
K811106 · DTB
Intermedics, Inc.
Cardiovascular · 34d
Cleared May 27, 1981
MEDTRONIC PULSE GENERATOR
K811123 · DXY
Medtronic Vascular
Cardiovascular · 33d
Cleared May 27, 1981
BLADE, TONGUE
K811157
Dyn-A-Med Products
General & Plastic Surgery · 29d
Cleared May 27, 1981
OMNI
K811158 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 29d
Cleared May 27, 1981
DYNASOUND 801
K811159 · IMI
Dynawave, Corp.
Physical Medicine · 29d
Cleared May 27, 1981
URETHANE ORTHOPAEDIC CASTING TAPE
K811164 · ITG
Hexcel Medical
Physical Medicine · 29d
Cleared May 27, 1981
VASCULON II I.V. CATHETER
K811171 · FOZ
Pioneer Viggo, Inc.
General Hospital · 29d
Cleared May 27, 1981
RECOH ROOT CANAL IRRIGATOR
K811175 · EFS
Koei International, Inc.
Dental · 29d
Cleared May 27, 1981
MEDTRONIC A2 CLINICAL IMAGING SYSTEM
K811187 · IYX
Medtronic Vascular
Radiology · 28d
Cleared May 27, 1981
DAVIS & GECK NEEDLE/SHARPS COUNTER
K811191 · KDC
Davis & Geck, Inc.
General & Plastic Surgery · 27d
Cleared May 27, 1981
HITACHI 705 AUTOMATIC BLOOD CHEMISTRY
K811194 · JJE
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared May 27, 1981
ULTRACHEM GLUC-DH, ITEM NO. 65048
K811202 · LFR
Harleco
Chemistry · 26d
Cleared May 27, 1981
INTERMEDICS CYBERLITH BIPOLAR CARDIAC
K811221 · DXY
Intermedics, Inc.
Cardiovascular · 23d
Cleared May 27, 1981
BODAI SUCTION -SAFE 4
K811241 · BSY
Sontek Industries, Inc.
Anesthesiology · 23d
Cleared May 27, 1981
CORNING 965 CARBON DIOXIDE ANALYZER
K811257 · CHS
Corning Medical & Scientific
Chemistry · 22d
Cleared May 27, 1981
BARALYME CO2 ABSORBENT
K811260 · CBL
Allied Healthcare Products, Inc.
Chemistry · 21d
Cleared May 27, 1981
EPSTEIN-BARR VIRUS CAPSID ANTIGEN ANTI
K811262 · JRY
Zeus Scientific, Inc.
Microbiology · 21d
Cleared May 27, 1981
CYCLIC AMP RADIOIMMUNOASSAY KIT [125I]
K811273 · CHO
Bd Becton Dickinson Vacutainer...
Chemistry · 20d
Cleared May 27, 1981
PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT
K811274 · JFH
Bd Becton Dickinson Vacutainer...
Chemistry · 20d
Cleared May 27, 1981
NOVA 5
K811289 · JGS
Nova Biomedical Corp.
Chemistry · 16d
Cleared May 27, 1981
CERVICAL SUPPORT
K811297 · IQF
Orthomedics
Physical Medicine · 16d