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
164185–164208 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 11, 1981
OPTOCRYL CONTACT LENS BLANKS
K810130 · HPX
Optacryl, Inc.
Ophthalmic · 143d
Cleared Jun 11, 1981
MODELS: 52-01-0, 52-01-1
K811110 · FPA
Y
General Hospital · 49d
Cleared Jun 09, 1981
OFFENBACK REVERSIBLE BARIUM PUMP
K803183 · FRN
The Offenback Co.
Radiology · 175d
Cleared Jun 09, 1981
CELL DYN 800 HEMATOLOGY ANALYZER
K803218 · GKL
Abbott Diagnostics
Hematology · 173d
Cleared Jun 09, 1981
COBE PPD .8
K810066 · FJG
Cobe Laboratories, Inc.
Gastroenterology & Urology · 147d
Cleared Jun 09, 1981
ULTRAPROBE
K810133 · IYN
Ars Magna
Radiology · 141d
Cleared Jun 09, 1981
PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM
K810699 · HLX
Visidyne Corp.
Ophthalmic · 85d
Cleared Jun 09, 1981
GE 900
K811103 · EHD
General Electric Co.
Radiology · 47d
Cleared Jun 09, 1981
BELMONT PODIATRY MODEL 065 X-RAY
K811142 · KPR
Belmont Equipment Corp.
Radiology · 43d
Cleared Jun 09, 1981
PANDOROS 1200A
K811149 · IZI
Siemens Corp.
Radiology · 43d
Cleared Jun 09, 1981
ARGOSTAT
K811195 · IYB
Tecnomed, Inc.
Radiology · 40d
Cleared Jun 09, 1981
ALLMEC 90/15
K811196 · KXJ
Tecnomed, Inc.
Radiology · 40d
Cleared Jun 09, 1981
SUPERIX 120
K811197 · IZF
Tecnomed, Inc.
Radiology · 40d
Cleared Jun 09, 1981
SORENSON CATALOG #IFL-120S
K811228 · CAC
Sorensen Research
Anesthesiology · 36d
Cleared Jun 09, 1981
SUR-FIT DISPOSABLE CONVEX INSERT
K811239 · EXB
E. R. Squibb & Sons, Inc.
Gastroenterology & Urology · 36d
Cleared Jun 09, 1981
ECONOMY OPEN END DRAINAGE BAG
K811300 · EXB
Economy Plus
Gastroenterology & Urology · 29d
Cleared Jun 09, 1981
MYO-METRIC II
K811312 · LBB
Mycron Medical, Inc.
Neurology · 29d
Cleared Jun 09, 1981
CARDIOPLEGIA COOLING & ADMIN. SETS
K811368 · KRI
Bentley Laboratories, Inc.
Cardiovascular · 26d
Cleared Jun 09, 1981
SHILEY ARTERIAL FILTER
K811379 · DTM
Shiley, Inc.
Cardiovascular · 25d
Cleared Jun 09, 1981
ESTRIOL KIT
K811380 · CGI
Cambridge Nuclear Corp.
Chemistry · 25d
Cleared Jun 09, 1981
DOWNS CAP FLOW GENERATOR
K811393 · BZR
Vital Signs, Inc.
Anesthesiology · 22d
Cleared Jun 09, 1981
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
K811399 · KRB
American Edwards Laboratories
Cardiovascular · 21d
Cleared Jun 09, 1981
TRAVELAIRE
K811404 · CCQ
B & F Medical Products, Inc.
Anesthesiology · 22d
Cleared Jun 09, 1981
VENTRE/SEP
K811423 · CFP
Ventrex Laboratories, Inc.
Chemistry · 19d