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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
148561–148584 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1985
880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR
K851717 · EMJ
Artiberia
Dental · 50d
Cleared Jun 14, 1985
COMPACT 2000
K851892 · KDQ
Atrium Medical Corp.
General Hospital · 45d
Cleared Jun 14, 1985
CORNING CERTAIN -ISE
K851939 · JIX
Corning Medical & Scientific
Chemistry · 42d
Cleared Jun 14, 1985
PENNINE OXYGEN LINK TUBING
K852081 · BYX
Pennine Medical , Ltd.
Anesthesiology · 32d
Cleared Jun 14, 1985
AXIOM ATRAUM TROCAR CATHETER
K852241 · GBS
Axiom Medical, Inc.
General & Plastic Surgery · 22d
Cleared Jun 14, 1985
STAND, OPERATING ROOM
K852329 · FOX
Scholten Surgical Instruments, Inc.
General Hospital · 14d
Cleared Jun 13, 1985
ROTAVIRUS ENZYME IMMUNOASSAY
K843367 · LIQ
Intl. Diagnostic Laboratories, Ltd.
Immunology · 289d
Cleared Jun 13, 1985
NEURO CUSTOM SURGICAL KIT
K844594 · HBA
Xanmed Corp.
Neurology · 199d
Cleared Jun 13, 1985
BUSHEL OFF-HEAD PREAMPLIFIER
K850418 · GWQ
Oxford Medilog, Inc.
Neurology · 129d
Cleared Jun 13, 1985
SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE
K850778 · FFT
Settler Medical Electronics, Inc.
Gastroenterology & Urology · 107d
Cleared Jun 13, 1985
SHARP DIGITAL BP MONITOR MB-371H
K850830 · DXN
Sharp Electronics Corp.
Cardiovascular · 127d
Cleared Jun 13, 1985
GRAVITY KING (DEEMED SE 87/09/18)
K851065 · ION
Unique Functional Products
Physical Medicine · 90d
Cleared Jun 13, 1985
TECA MONTAGE II
K851232 · GWQ
Teca, Inc.
Neurology · 79d
Cleared Jun 13, 1985
NEUROPACK 8, MEE-4108
K851300 · GWF
Nihon Kohden America, Inc.
Neurology · 73d
Cleared Jun 13, 1985
MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA
K851329 · JLW
Corning Medical & Scientific
Chemistry · 70d
Cleared Jun 13, 1985
1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE
K851748 · GWZ
Artiberia
Neurology · 49d
Cleared Jun 13, 1985
1-380 PINWHEEL (WARTENBERG)
K851749 · GWY
Artiberia
Neurology · 49d
Cleared Jun 13, 1985
ORTHOPEADIC CEMENT DELIVERY SYSTEM
K851881 · KIH
Dentsply Intl.
Orthopedic · 45d
Cleared Jun 13, 1985
VPDS-1 VENNES PANCREATIC DILATION SET
K851956 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 41d
Cleared Jun 13, 1985
E.R.C.P.-1 ENDOSCOPIC RETROGRADE CHOLANGIO-CATHETE
K851964 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 41d
Cleared Jun 13, 1985
SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL
K852070 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 34d
Cleared Jun 13, 1985
ALBA DRY BURN PAD
K852091 · NAD
Alba-Waldensian, Inc.
General & Plastic Surgery · 31d
Cleared Jun 13, 1985
WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S
K852138 · IAF
Canyon Diagnostics, Inc.
Pathology · 28d
Cleared Jun 13, 1985
STERILE SURGICAL BLADES
K852141 · GES
Miltex Instrument Co.
General & Plastic Surgery · 28d