FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
164785–164808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 30, 1980
HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.
K803016 · GKR
Helena Laboratories
Hematology · 32d
Cleared Dec 30, 1980
PROXIMATE*II DISPOSABLE SKIN STAPLER
K803038 · GAG
Ethicon, Inc.
General & Plastic Surgery · 29d
Cleared Dec 30, 1980
SERUM FREE TISSUE CULTURE MEDIA
K803041 · KIT
Cartaya Assoc.
Pathology · 29d
Cleared Dec 30, 1980
SPRAY, SYNTHETIC SMEAR
K803050 · IFI
Laboratory Products, Inc.
Pathology · 28d
Cleared Dec 30, 1980
HIGH FREQUENCY AUDIOMETER DELMAR #20-K
K803072 · EWO
Demlar Medical, Inc.
Ear, Nose, Throat · 25d
Cleared Dec 30, 1980
MENTOR 402 TRANSCUTANEOUS ELEC. STIMULAT
K803113 · GZJ
George H. Frisch
Neurology · 20d