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
147577–147600 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 1985
PENOX PERFORMER WHEELCHAIR
K852109 · IOR
Penox Technologies, Inc.
Physical Medicine · 99d
Cleared Aug 22, 1985
AML PROXIMAL POROCOAT FEMORAL HIP
K852198 · LPH
Depuy, Inc.
Orthopedic · 94d
Cleared Aug 22, 1985
LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT
K852237 · LHL
Genetic Systems Corp.
Microbiology · 92d
Cleared Aug 22, 1985
MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT
K852388 · DQY
Quinton, Inc.
Cardiovascular · 73d
Cleared Aug 22, 1985
RIONET HEARING AID HB-69HT
K852453 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 73d
Cleared Aug 22, 1985
DAH/BERG MODEL HP BEHIND-THE-EAR HEARING AID
K852486 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 72d
Cleared Aug 22, 1985
NEWPORT MEDIA TRANSFER CONTAINER
K852532 · KJA
Newport Bio Systems
Microbiology · 69d
Cleared Aug 22, 1985
ALL TERRAIN AMIGO
K852557 · INI
Amigo Sales, Inc.
Physical Medicine · 66d
Cleared Aug 22, 1985
POROUS APF/MODULAR FEMORAL COMPONENT
K852585 · JDI
Biomet, Inc.
Orthopedic · 65d
Cleared Aug 22, 1985
AMERICAN EDWARDS LABORATORIES FLEXISCOPE
K852759 · HRX
American Edwards Laboratories
Orthopedic · 55d
Cleared Aug 22, 1985
JAGUAR
K852809 · ITI
Inacare Corp.
Physical Medicine · 51d
Cleared Aug 22, 1985
RABBIT
K852810 · ITI
Invacare Corp.
Physical Medicine · 51d
Cleared Aug 22, 1985
RANGER-X
K852811 · ITI
Invacare Corp.
Physical Medicine · 51d
Cleared Aug 22, 1985
RANGER(II)
K852813 · ITI
Invacare Corp.
Physical Medicine · 51d
Cleared Aug 22, 1985
IMAGE-IGE
K853025 · DGC
Clinical Reference Laboratory, Inc.
Immunology · 35d
Cleared Aug 22, 1985
MODEL 372L HEARING AID
K853108 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 30d
Cleared Aug 22, 1985
APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN
K853174 · MSJ
Photec Diagnostics, Inc.
Immunology · 23d
Cleared Aug 22, 1985
CANNON BABYSAFE NIPPLE SHIELDS
K853176 · HFS
Medela, Inc.
General Hospital · 41d
Cleared Aug 22, 1985
MIC JEJUNAL FEEDING TUBE
K853197 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 23d
Cleared Aug 22, 1985
LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS)
K853261 · CZS
Behring Diagnostics, Inc.
Immunology · 20d
Cleared Aug 22, 1985
VACCESS TM 4006
K853283 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 17d
Cleared Aug 22, 1985
MULTISET 40
K853386 · BRZ
Migada, Ltd.
General Hospital · 10d
Cleared Aug 22, 1985
ET - EXTENSION SETS
K853387 · FPA
Migada, Ltd.
General Hospital · 10d
Cleared Aug 22, 1985
MONOSTICON UNI-DOT
K853388 · KTN
Organon, Inc.
Immunology · 9d