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

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175,820 results
139489–139512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 1987
VESTIBULAR AUTOROTATION TEST
K871466 · GWN
Western Systems Research, Inc.
Neurology · 101d
Cleared Jul 24, 1987
AEROCHAMBER
K872037 · BYP
Monaghan Medical Corp.
Anesthesiology · 58d
Cleared Jul 24, 1987
DEXTRANOMER
K872117 · KOZ
Interworld, Inc.
General & Plastic Surgery · 53d
Cleared Jul 24, 1987
DIDECO-SHILEY BLOOD SEPARATION WASH BOWL
K872160 · CAC
Shiley, Inc.
Anesthesiology · 50d
Cleared Jul 24, 1987
CART, EMERGENCY, CARDIOPULMONARY
K872558 · BZN
Nico Metal Products Corp.
Anesthesiology · 25d
Cleared Jul 24, 1987
HAND/FOOT 624-208
K872604 · FTC
National Biological Corp.
General & Plastic Surgery · 22d
Cleared Jul 24, 1987
HAND/FOOT UVA 624-218
K872605 · FTC
National Biological Corp.
General & Plastic Surgery · 22d
Cleared Jul 23, 1987
VIA-GUARD
K871950 · JOL
Surgimark, Inc.
General Hospital · 64d
Cleared Jul 23, 1987
NAIL SET
K872388 · LRY
Med-Tool, Inc.
General & Plastic Surgery · 34d
Cleared Jul 23, 1987
SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
K872393 · IMI
Henley Intl.
Physical Medicine · 41d
Cleared Jul 23, 1987
CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY
K872426 · DBA
Cytotech, Inc.
Immunology · 31d
Cleared Jul 23, 1987
AN3000 MAHONEY DRAIN
K872460 · GBS
H.W. Andersen Products, Inc.
General & Plastic Surgery · 30d
Cleared Jul 23, 1987
1.1 SCREWDRIVERS
K872490 · LRZ
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 30d
Cleared Jul 23, 1987
M.W.P. WRIST PROSTHESIS
K872502 · KWM
Protek, Inc.
Orthopedic · 29d
Cleared Jul 23, 1987
OMRON DIGITAL FEVER THERMOMETER MODEL MC-12B
K872527 · FLL
Omron Electronics, Inc.
General Hospital · 28d
Cleared Jul 23, 1987
TENSAGAIN
K872574 · GXY
Ferris Mfg. Corp.
Neurology · 23d
Cleared Jul 23, 1987
HOLDING ROD, SURGICAL FORCEPS, WEINSTEIN,12X2 3/4
K872595
Grimm & Norton
General & Plastic Surgery · 21d
Cleared Jul 23, 1987
QM300 C4 ANTIBODY PACK
K872599 · DBI
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 21d
Cleared Jul 23, 1987
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
K872653 · KHG
Em Diagnostic Systems, Inc.
Hematology · 16d
Cleared Jul 23, 1987
INFUSION STAND
K872729 · FOX
Camtec
General Hospital · 15d
Cleared Jul 23, 1987
FLUORTRAN - C(TM)
K872751 · LIO
Para Scientific Co.
Microbiology · 10d
Cleared Jul 23, 1987
ADDITIONS TO WSL NITROSPRAY CRYOSURGICAL UNITS
K872796 · GEH
Tower Mfg. Co., Inc.
General & Plastic Surgery · 16d
Cleared Jul 22, 1987
SONOLAYER - V, SSA-100A.
K863269 · ITX
Toshiba Medical Systems
Radiology · 331d
Cleared Jul 22, 1987
LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER
K871206 · GEX
Phase-R Corp.
General & Plastic Surgery · 119d