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

Filters: Cleared only ×
176,076 results
159241–159264 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 1982
ENZYME-TEST DIGOXIN
K823199 · KXT
Icl Scientific
Chemistry · 34d
Cleared Nov 29, 1982
125 I-DEHYDROEPIANDROSTERONE SULFATE
K823200 · JKC
Wien Laboratories, Inc.
Chemistry · 34d
Cleared Nov 29, 1982
HUMAN PLACENTAL LACTOGEN KIT
K823201 · JMF
Diagnostic Products Corp.
Chemistry · 34d
Cleared Nov 29, 1982
ABUSCREEN RADIOIMMUNOASSAY - AMPHETAMINE
K823212 · DJP
Hoffmann-La Roche, Inc.
Chemistry · 32d
Cleared Nov 29, 1982
SBA 300 CLINICAL CHEMISTRY ANALYZER
K823233 · JJC
Gilford Instrument Laboratories, Inc.
Chemistry · 31d
Cleared Nov 29, 1982
BARBITURATE TEST SET #0550-050
K823237 · DJN
Stanbio Laboratory
Toxicology · 28d
Cleared Nov 29, 1982
MODEL WHO1 HEARING AID
K823285 · ESD
Panasonic Co. Div. Matsu Elec. Corp....
Ear, Nose, Throat · 25d
Cleared Nov 29, 1982
HEARING AID UE-10-H
K823366 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 29, 1982
LEG PREP HOLDER
K823391
Orthopedic Systems, Inc.
General & Plastic Surgery · 17d
Cleared Nov 29, 1982
FOREARM REDUCTION UNIT
K823392 · HST
Orthopedic Systems, Inc.
Neurology · 17d
Cleared Nov 29, 1982
FREE FLEX HEEL HEIGHT ADJUSTOR
K823396 · ISH
Orthopedic Systems, Inc.
Physical Medicine · 17d
Cleared Nov 29, 1982
ANATOMIC FRACTURE BRACE
K823397 · ITQ
Orthopedic Systems, Inc.
Physical Medicine · 17d
Cleared Nov 29, 1982
COVER LIMB
K823399 · IPM
Orthopedic Systems, Inc.
Physical Medicine · 17d
Cleared Nov 29, 1982
ARTHROSCOPIC LEG HOLDER
K823400
Orthopedic Systems, Inc.
General & Plastic Surgery · 17d
Cleared Nov 27, 1982
SARTOPHOR SYSTEM FOR ELECTROPHORESIS
K823132 · JJN
Sartorius Filters, Inc.
Chemistry · 33d
Cleared Nov 24, 1982
PRESS-O-TEST
K822102 · DXN
Medi-Swiss Corp.
Cardiovascular · 131d
Cleared Nov 24, 1982
MODEL 366-07 ADAPT AID LEAD ADAPTER
K822704 · DTD
Intermedics, Inc.
Cardiovascular · 78d
Cleared Nov 24, 1982
FLO CONTROL
K822891 · LDR
Dna Medical, Inc.
General Hospital · 57d
Cleared Nov 24, 1982
MODEL LS-85 & MEDEL 1828 LINESCAN VISCO
K822926
Honeywell, Inc.
Cardiovascular · 54d
Cleared Nov 24, 1982
HEART RATE & TEMP. MEASUREMENT SYSTEM
K822939 · FLL
Camino Laboratories, Inc.
General Hospital · 51d
Cleared Nov 24, 1982
MINGOCARD 7 & MINGOPHONE 7
K822983 · DSF
Siemens Corp.
Cardiovascular · 47d
Cleared Nov 24, 1982
COMPUTER INTERFACE MODULE CIM
K823035 · FRN
Y
General Hospital · 41d
Cleared Nov 24, 1982
JEOL MODEL #JTG-500M
K823041 · IYM
Jeol
Radiology · 41d
Cleared Nov 24, 1982
VAKUTAGE
K823080 · HHK
Weston, Copco, Inc.
Obstetrics & Gynecology · 36d