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

Filters: Cleared only ×
175,820 results
149689–149712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 25, 1985
EARETTE HEARING AID OTICON MODEL E32S
K850762 · ESD
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Mar 25, 1985
EARETTE HEARING AID OTICON E32U
K850763 · ESD
Oticon Corp.
Ear, Nose, Throat · 28d
Cleared Mar 25, 1985
BRONCHITRAC L
K850784 · BSY
Ackrad Laboratories
Anesthesiology · 27d
Cleared Mar 25, 1985
DIAFLEX OCCLUSION BALLOON CATHETER
K850790 · KOD
American Edwards Laboratories
Gastroenterology & Urology · 27d
Cleared Mar 25, 1985
CORNING BLOOD COLLECTION CAPILLARY TUBES
K850806 · GIO
Corning Medical & Scientific
Hematology · 26d
Cleared Mar 25, 1985
COBAS FP REAGENTS FOR QUINIDINE
K850808 · LBZ
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Mar 25, 1985
MCCOY'S 5A M9270 W/L-GLUTAMINE & W/O PHENOL RED &
K850890 · KIT
Sigma Chemical Co.
Microbiology · 21d
Cleared Mar 25, 1985
DULBECCO'S MODIFIED EAGLE'S MEDIUM D7777, W/L-GLUT
K850891 · KIT
Sigma Chemical Co.
Microbiology · 21d
Cleared Mar 25, 1985
TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA
K850908 · JTC
Flow Laboratories, Inc.
Microbiology · 20d
Cleared Mar 25, 1985
SPRAYFIX
K850916 · PPM
Surgipath Medical Industries, Inc.
Pathology · 20d
Cleared Mar 25, 1985
MEM, M7270, W/EBSS, L-GLUTAMINE & W/O L-LEUCINE -
K850921 · KIT
Sigma Chemical Co.
Microbiology · 20d
Cleared Mar 25, 1985
MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL
K850922 · KIT
Sigma Chemical Co.
Microbiology · 20d
Cleared Mar 25, 1985
DUPONT PREP TYPE SI EXTRACITON CARTRIDGE
K850963 · DJY
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 17d
Cleared Mar 25, 1985
FLEXUS 2 CO2 SURGICAL LASER SYSTEM
K850985 · GEX
Intl. Solarium Manufacturer, Inc.
General & Plastic Surgery · 14d
Cleared Mar 22, 1985
GST SYSTEM THERMOGRAPHIC APPLICATION
K842878 · LHQ
Gst Laboratories of Ca, Inc.
Radiology · 242d
Cleared Mar 22, 1985
HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8
K844897 · JPK
Medical Specialties Laboratories
Hematology · 95d
Cleared Mar 22, 1985
QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS
K844927 · JPK
Bhp Diagnostix, Inc.
Hematology · 93d
Cleared Mar 22, 1985
QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE
K844928 · JPK
Bhp Diagnostix, Inc.
Hematology · 93d
Cleared Mar 22, 1985
KELLER CEPHALOMETRIC DEVICE
K850197 · IWY
Gary D. Keller
Radiology · 63d
Cleared Mar 22, 1985
AMERICAN PHARMASEAL STERILE I.V. START KIT
K850266
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 58d
Cleared Mar 22, 1985
SUPLEX & SUPLEX DILUENT
K850302 · JSK
Pro-Lab, Inc.
Microbiology · 59d
Cleared Mar 22, 1985
CINE RADIOGRAPHIC FILM PROCESSOR M-45CR
K850421 · IXX
The Allen Products Co.
Radiology · 46d
Cleared Mar 22, 1985
CUE FERTILITY MONITOR
K850579 · NGE
Zetek, Inc.
Toxicology · 37d
Cleared Mar 22, 1985
SURGI-PAP KIT
K850676 · HHT
Surgipath Medical Industries, Inc.
Obstetrics & Gynecology · 29d