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

Filters: Cleared only ×
176,076 results
163969–163992 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1981
HEMOTOLOGY QUALITY CONTROL MIXTURES
K810756 · JPK
Scientific Standards, Inc.
Hematology · 102d
Cleared Jun 30, 1981
ALPHA MICRON-40 FILTER
K810761 · CAK
Alpha Therapeutic Corp.
General Hospital · 102d
Cleared Jun 30, 1981
CENTRAL STATION MONITORING SYSTEMS
K811121 · DPS
Cambridge Instruments, Inc.
Cardiovascular · 67d
Cleared Jun 30, 1981
VITA-STAT MODEL 8000-C
K811146 · DSK
Vita-Stat
Cardiovascular · 64d
Cleared Jun 30, 1981
VITA-STAT MODEL 9000-A
K811147 · DSK
Vita-Stat
Cardiovascular · 64d
Cleared Jun 30, 1981
VITA-STAT MODEL 9000-S
K811148 · DSK
Viat-Stat
Cardiovascular · 64d
Cleared Jun 30, 1981
OCCLUSION CATHETER
K811276 · DYG
Bionomy, Inc.
Cardiovascular · 53d
Cleared Jun 30, 1981
MODEL 5866-24 LEAD ADAPTOR KIT
K811349 · DTD
Medtronic Vascular
Cardiovascular · 48d
Cleared Jun 30, 1981
TELETRACE TELEPHONE EKG SYSTEM
K811512 · DXH
Medtronic Vascular
Cardiovascular · 33d
Cleared Jun 30, 1981
NORELCO ANEROID BLOOD PRESSURE METER
K811634 · DXQ
North American Philips Corp.
Cardiovascular · 20d
Cleared Jun 30, 1981
NORELCO DIGITAL BLOOD PRESSURE METER
K811635 · DXN
North American Philips Corp.
Cardiovascular · 20d
Cleared Jun 30, 1981
NORELCO ELECTRONIC BLOOD PRESSURE METER
K811636 · DXN
North American Philips Corp.
Cardiovascular · 20d
Cleared Jun 30, 1981
I.V. ADMINISTRATION SET
K811685 · FPA
Quest Medical, Inc.
General Hospital · 15d
Cleared Jun 29, 1981
ECCO GENERATOR
K811198 · IZO
Philips Medical Systems (Cleveland),...
Radiology · 60d
Cleared Jun 26, 1981
SUCTION WOUND DRAINAGE DEVICE
K810739 · KQT
The Urology Group
Gastroenterology & Urology · 99d
Cleared Jun 26, 1981
SUMMAR NON-PRECIOUS, CERAMIC ALLOY
K811013 · EJH
Shofu Dental Corp.
Dental · 72d
Cleared Jun 26, 1981
SKIN SCRUB TRAY
K811287
Associated Medical Products Co.
General & Plastic Surgery · 49d
Cleared Jun 26, 1981
SPETZLER LUMBAR-PERITONEAL SYSTEM
K811288 · JXG
American Heyer Schulte
Neurology · 46d
Cleared Jun 26, 1981
SONUS V
K811396 · ELC
California Technics, Inc.
Dental · 39d
Cleared Jun 26, 1981
SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS
K811434 · JSS
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Jun 26, 1981
SHILEY DISPOSABLE CANNULA TRACH. TUBE
K811447 · BTO
Shiley, Inc.
Anesthesiology · 35d
Cleared Jun 26, 1981
K-FLEX
K811519
Sybron Corp.
Dental · 29d
Cleared Jun 26, 1981
FUJI IONOMER TYPE I & II
K811521 · EMA
G-C Intl. Corp.
Dental · 28d
Cleared Jun 26, 1981
RE-HP SERIES HEARING AIDS
K811522 · ESD
Radioear Corp.
Ear, Nose, Throat · 28d