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
145321–145344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1986
EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET
K853856 · HFM
Aequitron Medical, Inc.
Obstetrics & Gynecology · 177d
Cleared Mar 12, 1986
FLEXIBLE GRASPING FORCEPS
K854112 · EWL
Hood Laboratories
Ear, Nose, Throat · 155d
Cleared Mar 12, 1986
HEMATOLOGY CALIBRATOR CONTROL
K854166 · KRZ
Interscience Diagnostics, Inc.
Hematology · 148d
Cleared Mar 12, 1986
DUMON/HARRELL
K854414 · EOQ
Bryan Corp.
Ear, Nose, Throat · 128d
Cleared Mar 12, 1986
S.T.P.B SOFT TISSUES PROTECTIVES BLADES
K854467 · EEJ
Nortex USA, Inc.
Dental · 126d
Cleared Mar 12, 1986
GL590 DIAGNOSTIC ULTRASOUND EQUIPMENT
K854555 · IYO
Gl Ultrasound , Ltd.
Radiology · 118d
Cleared Mar 12, 1986
GOLD AIR, GOLD LIGHT
K854645 · EFB
Alpine Dental Equipment Co.
Dental · 113d
Cleared Mar 12, 1986
EZ-ON TUBING CONDITIONER (LUBRICANT)
K854700
Almore Intl., Inc.
Dental · 111d
Cleared Mar 12, 1986
COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.
K854938 · JPA
Diatech, Inc.
Hematology · 92d
Cleared Mar 12, 1986
PERINATAL COMPUTER SYS MODEL 100A & 100B
K855044 · HGM
Peritronics Research and Development,...
Obstetrics & Gynecology · 85d
Cleared Mar 12, 1986
SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE
K855064 · CAK
Cobe Laboratories, Inc.
General Hospital · 84d
Cleared Mar 12, 1986
CONVEX PROBE, PVE-382M
K855124 · IYO
Toshiba Medical Systems
Radiology · 79d
Cleared Mar 12, 1986
BEHIND THE EAR HEARING AIDS MODEL
K855240 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 71d
Cleared Mar 12, 1986
AM 12, HEARING AID
K860007 · ESD
Electone, Inc.
Ear, Nose, Throat · 68d
Cleared Mar 12, 1986
AM 31, HEARING AID
K860008 · ESD
Electone, Inc.
Ear, Nose, Throat · 68d
Cleared Mar 12, 1986
DENPAX
K860058 · EBR
Nissho Iwai American Corp.
Dental · 65d
Cleared Mar 12, 1986
A & M DISCREET - HEARING AID
K860190 · ESD
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 12, 1986
PA PRESIDENTIAL II - HEARING AID
K860191 · ESD
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 12, 1986
A & M 150 PP (HEARING AID)
K860244 · ESD
Electone, Inc.
Ear, Nose, Throat · 47d
Cleared Mar 12, 1986
ENTROKIT WITH MAGLINTE CATHETER
K860441 · KGC
Lafayette Pharmacal, Inc.
Gastroenterology & Urology · 36d
Cleared Mar 12, 1986
GIBCO MYCOTECT KIT (CATALOG NO. 189-5672)
K860695 · KIW
Gibco Laboratories Life Technologies,...
Microbiology · 15d
Cleared Mar 12, 1986
MICRO CARRIER
K860783 · KIT
Tissue Culture Innovations
Pathology · 9d
Cleared Mar 12, 1986
DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2
K860784 · KIP
Tissue Culture Innovations
Pathology · 9d
Cleared Mar 12, 1986
HAM'S F-12 W/NAHCO3
K860785 · KIT
Tissue Culture Innovations
Pathology · 9d