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
158281–158304 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 10, 1983
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K830307 · KWL
Howmedica Corp.
Orthopedic · 38d
Cleared Mar 10, 1983
AIRCARE 300
K830324 · CAW
Med.Com
Anesthesiology · 37d
Cleared Mar 10, 1983
SALT BRIDGE SOLUTION & URINE DILUENT
K830341 · JIX
Shaban Mfg. Co.
Chemistry · 36d
Cleared Mar 10, 1983
SCOOTER, VEHICLE MOTORIZED
K830345 · INI
Amigo Sales, Inc.
Physical Medicine · 41d
Cleared Mar 10, 1983
KINETI COUNT 48 IMMUNOASSAY SYSTEM
K830365 · JJJ
Medical & Scientific Designs, Inc.
Chemistry · 34d
Cleared Mar 10, 1983
TDX METHOTREXATE
K830398 · LAO
Abbott Laboratories
Chemistry · 31d
Cleared Mar 10, 1983
COUPLING/VALVE
K830399 · BTC
Khi, Inc.
Anesthesiology · 31d
Cleared Mar 10, 1983
LBI-100 37DEGREES INCUBATOR
K830405 · JTQ
Bionetic Laboratory Products
Chemistry · 31d
Cleared Mar 10, 1983
ICY COLD ICE CAP
K830416 · IME
Ladora Ent.
Physical Medicine · 30d
Cleared Mar 10, 1983
TACTAID
K830418 · LRA
Audiological Engineering Corp.
Ear, Nose, Throat · 30d
Cleared Mar 10, 1983
OTICON, E25P
K830435 · ESD
Octicon Corp.
Ear, Nose, Throat · 29d
Cleared Mar 10, 1983
OTICON, E-27P
K830436 · ESD
Octicon Corp.
Ear, Nose, Throat · 29d
Cleared Mar 10, 1983
LATERAL POSITIONING ATTACHMENT
K830443
Berivon Co.
Physical Medicine · 28d
Cleared Mar 10, 1983
ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE
K830479 · DKN
Hoffmann-La Roche, Inc.
Toxicology · 23d
Cleared Mar 10, 1983
LIQUID OXYGEN SYSTEM
K830498 · BYJ
Puritan Bennett Corp.
Anesthesiology · 22d
Cleared Mar 10, 1983
LIC TILT BED
K830633 · INQ
Century Manufacturing Co.
Physical Medicine · 9d
Cleared Mar 09, 1983
SURE-COUNT DISPOSABLE NEEDLE COUNTER
K822735 · MMK
Geneva Laboratories, Inc.
General Hospital · 181d
Cleared Mar 09, 1983
URINARY BLADDER TEMP. SENSOR #81-003
K823077 · FLL
Clinical Technology Corp.
General Hospital · 141d
Cleared Mar 09, 1983
ENDOMED 433
K823362
Kipp & Zonen
Physical Medicine · 120d
Cleared Mar 09, 1983
ALES
K823385 · HPG
Oms
Ophthalmic · 114d
Cleared Mar 09, 1983
P-S CSF-VENTRICULAR CATHETER, FLANGED
K823503 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 105d
Cleared Mar 09, 1983
SPECTRON PROXIMAL FEMORAL PROSTHESIS
K823723 · JDI
Richard'S Medical Equip., Inc.
Orthopedic · 89d
Cleared Mar 09, 1983
SPECTRON NECK REPLACEMENT PROSTHESIS
K823724 · JDI
Richard'S Medical Equip., Inc.
Orthopedic · 89d
Cleared Mar 09, 1983
SPECTRON CONVERSION ENDOPROSTHESIS CUP
K823726 · KWY
Richard'S Medical Equip., Inc.
Orthopedic · 89d