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
149089–149112 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 1985
THERMOMED
K851704 · FLL
Draeger Medical, Inc.
General Hospital · 15d
Cleared May 10, 1985
DATA TRAC ANESTHESIOLOGY RECORDER
K851904 · KZD
Datascope Corp.
General Hospital · 10d
Cleared May 09, 1985
CATARACT TRAY
K842647 · HNN
Deroyal Industries, Inc.
Ophthalmic · 303d
Cleared May 09, 1985
STERILE EYE SURGERY KITS
K842990 · HOZ
Biological & Environmental Control...
Ophthalmic · 283d
Cleared May 09, 1985
IOCARE CONVERTER KIT
K843276 · HQC
Chiron Vision Corp.
Ophthalmic · 262d
Cleared May 09, 1985
MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL
K844440 · LKW
Cooper Lasersonics, Inc.
Neurology · 174d
Cleared May 09, 1985
PHARMASEAL EYE PREP TRAY
K850119 · HNR
American Pharmaseal Div. Ahsc
Ophthalmic · 115d
Cleared May 09, 1985
HERPES SIMPLEX GROUP CF ANTIGEN
K850609 · GQN
Hillcrest Biologicals
Microbiology · 83d
Cleared May 09, 1985
MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA
K850793 · JDL
Intermedics Orthopedics
Orthopedic · 72d
Cleared May 09, 1985
SENTINOL -ORTHODONTIC ARCH WIRE
K851055 · DZC
Gac Intl., Inc.
Dental · 56d
Cleared May 09, 1985
INOX DRY HEAT STERILIZER
K851307 · KMH
Broadwest Corp.
General Hospital · 38d
Cleared May 09, 1985
BIGGY AGAR NICKERSONS MEDIUM
K851576 · JSH
Preferred Micro-Media
Microbiology · 23d
Cleared May 09, 1985
SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420
K851883 · HDA
The Huxley Instrument Corp.
Obstetrics & Gynecology · 10d
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE REF. PLASMA
K850409 · JPA
Warner-Lambert Co.
Hematology · 93d
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY
K850410 · DDX
Warner-Lambert Co.
Immunology · 93d
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY
K850411 · LGP
Warner-Lambert Co.
Immunology · 93d
Cleared May 08, 1985
GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY
K850412 · JBQ
Warner-Lambert Co.
Hematology · 93d
Cleared May 08, 1985
GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
K850486 · KFF
Warner-Lambert Co.
Hematology · 90d
Cleared May 08, 1985
ABCO SUCTION CANISTER
K851316 · KDQ
Abco Dealers, Inc.
General Hospital · 36d
Cleared May 08, 1985
IMED GRAVISET INTRAVASCULAR ADMIN. SET
K851360 · FRN
Imed Corp.
General Hospital · 34d
Cleared May 08, 1985
MEDICAL/SURGICAL SUCTION SYSTEM
K851384 · GCX
Puritan Bennett Corp.
General Hospital · 29d
Cleared May 08, 1985
IVAC MODEL 580 GENER. USE VOLUMETRIC INFUSION PUMP
K851447 · FRN
Y
General Hospital · 44d
Cleared May 08, 1985
MERIVAARA ELECTRIC HOSPITAL BED & ACCESSORIES
K851551 · FNL
Daun International, Inc.
General Hospital · 22d
Cleared May 08, 1985
MERIVAARA HOSPITAL BED
K851552 · FNJ
Daun International, Inc.
General Hospital · 22d