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
152881–152904 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 1984
SLIDE PREGNANCY TEST
K842110 · JHJ
Immunostics Co., Inc.
Chemistry · 44d
Cleared Jul 12, 1984
WAKO GLUCOSE C
K842221 · CGA
Wako Pure Chemical Industries, Ltd.
Chemistry · 37d
Cleared Jul 11, 1984
RELIABLE
K834479 · LRB
Reliable Hearing Aide
Ear, Nose, Throat · 204d
Cleared Jul 11, 1984
BETA STICK, PREGNANCY TEST
K841415 · LCX
Quidel Corp.
Chemistry · 97d
Cleared Jul 11, 1984
DRILL GUIDE
K841619 · FZX
Plastafil, Inc.
General & Plastic Surgery · 83d
Cleared Jul 11, 1984
SOFT-TISSUE INSTRUMENT
K841622 · HWQ
Plastafil, Inc.
Orthopedic · 83d
Cleared Jul 11, 1984
SLOTTED SOFT-TISSUE INSTRUMENT
K841623 · HWQ
Plastafil, Inc.
Orthopedic · 83d
Cleared Jul 11, 1984
OHIO WASTE GAS SCAVENGING RESERVOIR
K841733 · CBN
Ohio Medical Products
Anesthesiology · 76d
Cleared Jul 11, 1984
SPIROLOOP
K841858 · BSE
Datamed, Inc.
Anesthesiology · 68d
Cleared Jul 11, 1984
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
K841864 · DEH
Kallestad Laboratories, Inc.
Immunology · 68d
Cleared Jul 11, 1984
COOK PACEMAKER 215 UNIPOLAR CARDIAC-
K841928 · DXY
Cook Pacemaker Corp.
Cardiovascular · 62d
Cleared Jul 11, 1984
COOK PACEMAKER 216 BIPOLAR CARDIAC -
K841983 · DXY
Cook Pacemaker Corp.
Cardiovascular · 57d
Cleared Jul 11, 1984
H-TYPE BRIDGE REMOVER
K842026 · EIS
Higa Manufacturing , Ltd.
Dental · 54d
Cleared Jul 11, 1984
IL 1312, PH BLOOD GAS MANAGER
K842042
Instrumentation Laboratory CO
Chemistry · 51d
Cleared Jul 11, 1984
FIAX TRANSFERRIN TEST KIT
K842071 · DDI
Intl. Diagnostic Technology
Immunology · 49d
Cleared Jul 11, 1984
STRATUS PRIMIDONE FLOROMETRIC ENZY
K842196 · LFT
American Dade
Toxicology · 37d
Cleared Jul 11, 1984
LEAP LE TEST KIT
K842484 · LKJ
Cooper Biomedical, Inc.
Immunology · 16d
Cleared Jul 11, 1984
BIRD HEATED HUMIDIFIER 3201
K842523 · BTT
3M Company
Anesthesiology · 14d
Cleared Jul 11, 1984
SHERIDAN/INTENSA TUBE
K842558 · BTR
Sheridan Catheter Corp.
Anesthesiology · 9d
Cleared Jul 11, 1984
STREP-A-CHEK
K842600 · JSF
E-Y Laboratories, Inc.
Microbiology · 8d
Cleared Jul 10, 1984
BECTON DICKINSON 1000 INSULIN PUMP
K842685
Bd Becton Dickinson Vacutainer...
General Hospital
Cleared Jul 09, 1984
SILA CLEAN 20/20
K832327
Professional Supplies, Inc.
Ophthalmic · 360d
Cleared Jul 09, 1984
OSTOMY FREEDOM KIT
K841173 · EXB
Ellenberg Assoc.
Gastroenterology & Urology · 112d
Cleared Jul 09, 1984
CYSTO-AID
K841197 · KNX
E-Z-Em, Inc.
Gastroenterology & Urology · 110d