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
165625–165648 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 1980
RESPIRATORY SYNCYTIAL VIRUS ANTIGEN &
K802936 · GQG
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared Dec 31, 1980
RUBELLA VIRUS ANTIGENS & CONTROLS
K802937 · GON
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared Dec 31, 1980
VARICELLA-ZOSTER ANTIGENS & CONTROLS
K802938 · GQW
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared Dec 31, 1980
HERPES SIMPLEX TYPE I
K802939 · GON
Orion Diagnostica, Inc.
Microbiology · 42d
Cleared Dec 31, 1980
TRANSDUCER DOME, CAT.#SD-101
K802961 · DRQ
Sorensen Research
Cardiovascular · 40d
Cleared Dec 31, 1980
DISPOSABLE DIAPHRAGM DONE
K803011 · DRQ
Sorensen Research
Cardiovascular · 33d
Cleared Dec 31, 1980
ZIMMER ELECTRICAL MUSCLE STIMULATOR
K803064 · IPF
Zimmer, Inc.
Physical Medicine · 27d
Cleared Dec 31, 1980
ORTHO HEMATOLOGY CONTROL
K803073 · JPK
Ortho Instruments
Hematology · 26d
Cleared Dec 31, 1980
ORTHO HEMOTOLOGY CONTROL-NORMAL
K803083 · JPK
Ortho Instruments
Hematology · 26d
Cleared Dec 31, 1980
ORTHO HEMATOLOGY CONTROL ABNORMAL LOW
K803084 · JPK
Ortho Instruments
Hematology · 26d
Cleared Dec 31, 1980
SARNS INFANT ARTERIAL BUBBLE SENSOR
K803105 · KPL
3M Health Care, Sarns
Gastroenterology & Urology · 22d
Cleared Dec 31, 1980
ACETABULAR CEMENT COMPRESSOR
K803165 · HXO
Zimmer, Inc.
Orthopedic · 16d
Cleared Dec 31, 1980
MOIST HEAT PACK
K803177 · IMA
Duro-Med Ind., Inc.
Physical Medicine · 15d
Cleared Dec 30, 1980
RODEL ELECTRODERM PADS
K802658 · GYB
Rodel Products Corp.
Neurology · 67d
Cleared Dec 30, 1980
DISPERSALLOY-DISPERSED PHASE ALLOY SELF-
K802967 · DZS
Johnson & Johnson Professionals, Inc.
Dental · 39d
Cleared Dec 30, 1980
THE INQUINAL RESORVOIR INSERTER
K802983 · KOA
Lone Star Medical Products, Inc.
Gastroenterology & Urology · 39d
Cleared Dec 30, 1980
MEISINGER DIAMOND DENTAL BURS
K802984 · DZP
Swiss American Metal Craft Corp.
Dental · 39d
Cleared Dec 30, 1980
JOTA DIAMOND DENTAL BURS
K802987 · DZP
Swiss American Metal Craft Corp.
Dental · 39d
Cleared Dec 30, 1980
JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS
K802988 · EJL
Swiss American Metal Craft Corp.
Dental · 39d
Cleared Dec 30, 1980
MEISINGER TUNGSTEN CARBIDE & STEEL DT.B.
K802989 · EJL
Swiss American Metal Craft Corp.
Dental · 39d
Cleared Dec 30, 1980
ROLL STRETCH GAUZE
K802991 · FQM
Abco Dealers, Inc.
General Hospital · 39d
Cleared Dec 30, 1980
ELASTIC GAUZE
K802992 · FQM
Abco Dealers, Inc.
General Hospital · 39d
Cleared Dec 30, 1980
SHUR-PATCH TAPE PATCH
K803012 · GXY
Shur Medical Corp.
Neurology · 32d
Cleared Dec 30, 1980
HEMESPEC II
K803015 · GKR
Helena Laboratories
Hematology · 32d