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
147193–147216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 1985
COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT
K853100 · DYB
Cobe Laboratories, Inc.
Cardiovascular · 64d
Cleared Sep 25, 1985
HOT OR HEAT PACK
K853148 · IMD
Matrix Intl.
Physical Medicine · 58d
Cleared Sep 25, 1985
ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT
K853539 · JHI
Abbott Laboratories
Chemistry · 33d
Cleared Sep 25, 1985
EASY ANALYZER & EASY-TEST REAGENT
K853699 · JJE
Diagnostic Systems
Chemistry · 21d
Cleared Sep 25, 1985
APOLLO DENSITOMETER
K853734 · JQT
Astral Medical Systems
Chemistry · 19d
Cleared Sep 24, 1985
HESSBURG GLIDE UNTRAOCULAR LENS GUIDES
K852529 · HQF
Visitec Co.
Ophthalmic · 102d
Cleared Sep 24, 1985
GENTLE LIFT-RECLINER CHAIR
K852864 · INO
Pride Health Care Equipment
Physical Medicine · 78d
Cleared Sep 24, 1985
HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM
K853033 · KWQ
A.W. Showell (Surgicraft) , Ltd.
Orthopedic · 68d
Cleared Sep 24, 1985
SILASTIC INFLATABLE BONE PLUG H.P.
K853186 · LZN
Dow Corning Corp. Healthcare...
Orthopedic · 56d
Cleared Sep 24, 1985
CREAT BRAND I/A PACK CREAT BRAND PHACO PACK
K853189 · HQC
Aesthetech Corp.
Ophthalmic · 56d
Cleared Sep 24, 1985
RELIANCE 1379
K853359 · HRJ
Dentsply Intl.
Ophthalmic · 43d
Cleared Sep 24, 1985
MICRON-SCOPE
K853499 · HNN
Magnum Diamond, Inc.
Ophthalmic · 35d
Cleared Sep 24, 1985
STAINLESS STEEL & CARBON STEEL STERILE BLADES
K853528 · GES
Abco Dealers, Inc.
General & Plastic Surgery · 32d
Cleared Sep 24, 1985
VESSA TRAVVLA
K853593 · ITI
Vessa , Ltd.
Physical Medicine · 28d
Cleared Sep 24, 1985
VESSA FLIVVA
K853594 · ITI
Vessa , Ltd.
Physical Medicine · 28d
Cleared Sep 24, 1985
BURS FOR MICRO SURGICAL DRILL SYSTEM
K853658 · GFF
Acumed Instruments Corp.
General & Plastic Surgery · 21d
Cleared Sep 24, 1985
POWERED IRRIGATION FOR MICRO SURGICAL DRILL
K853659
Acumed Instruments Corp.
General & Plastic Surgery · 21d
Cleared Sep 24, 1985
MICRO SURGICAL DRILL SYSTEM
K853660
Acumed Instruments Corp.
General & Plastic Surgery · 21d
Cleared Sep 24, 1985
MUELLER CURVED STEM HEMI-PROSTHESIS
K853662 · KWL
Protek, Inc.
Orthopedic · 21d
Cleared Sep 24, 1985
KAMBIN SPINAL INSTRUMENT SET
K853678 · HTZ
Pilling Co.
General & Plastic Surgery · 21d
Cleared Sep 23, 1985
SONOLAYER-L SAL-32B
K851240 · ITX
Toshiba Medical Systems
Radiology · 180d
Cleared Sep 23, 1985
HERAENIUM CA
K851515 · EJH
Heraeus Dental Gold Corp.
Dental · 161d
Cleared Sep 23, 1985
SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE
K851524 · DZM
Specialites Septodont
Dental · 160d
Cleared Sep 23, 1985
CONVEX PROBE, PVE-393M
K851526 · ITX
Toshiba Medical Systems
Radiology · 161d