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
126937–126960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1990
FACTOR XII DEFICIENT PLASMA
K900412 · GJT
Sigma Chemical Co.
Hematology · 36d
Cleared Mar 06, 1990
OSTEONICS CEMENT RESTRICTOR
K900462 · JDK
Osteonics Corp.
Orthopedic · 34d
Cleared Mar 06, 1990
3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100
K900605 · DTD
Possis Medical, Inc.
Cardiovascular · 26d
Cleared Mar 06, 1990
ALPHA URINE SAMPLE
K900626 · DIF
Toxi-Lab, Inc.
Chemistry · 26d
Cleared Mar 06, 1990
MODIFIED CAPTIA(R) TOXO-M
K900655 · LGD
Mercia Diagnostics , Ltd.
Microbiology · 25d
Cleared Mar 06, 1990
RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT
K900875 · DDG
Reagents Applications, Inc.
Chemistry · 8d
Cleared Mar 06, 1990
FACTOR II DEFICIENT PLASMA
K900906 · GJT
Sigma Chemical Co.
Hematology · 7d
Cleared Mar 05, 1990
EXMOOR BITE BUFFER
K893006 · EOQ
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 315d
Cleared Mar 05, 1990
REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
K894259 · HIG
Washington Regulatory Services
Obstetrics & Gynecology · 258d
Cleared Mar 05, 1990
FRANK MILK PUMP
K895114 · HGX
Buttner-Frank GmbH
Obstetrics & Gynecology · 202d
Cleared Mar 05, 1990
GYNECOLOGICAL INSTRUMENTATION
K895225 · HET
Gynescope Corp.
Obstetrics & Gynecology · 203d
Cleared Mar 05, 1990
IN THE EAR HEARING AID
K895368 · ESD
Hearing Crafters of America
Ear, Nose, Throat · 188d
Cleared Mar 05, 1990
ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
K895449 · HGL
Ge Medical Systems Information...
Obstetrics & Gynecology · 194d
Cleared Mar 05, 1990
MD5 AUTOMATIC AUDIOMETER
K896909 · EWO
Singer Medical Products, Inc.
Ear, Nose, Throat · 84d
Cleared Mar 05, 1990
HYSTEROSCOPE
K896917 · HIH
Cabot Medical Corp.
Obstetrics & Gynecology · 84d
Cleared Mar 05, 1990
FILPOST
K896928 · ELR
Ivoclar North America, Inc.
Dental · 84d
Cleared Mar 02, 1990
COULTER CLONE T4 MONOCLONAL ANTIBODY
K893852 · GKZ
Coulter Immunology
Hematology · 281d
Cleared Mar 02, 1990
COULTER CLONE T8 MONOCLONAL ANTIBODY
K893853 · GKZ
Coulter Immunology
Hematology · 281d
Cleared Mar 02, 1990
WHITESIDE ORTHOLOC MODULAR METAL-BACKED PATELLA
K896081 · JWH
Dow Corning Wright
Orthopedic · 134d
Cleared Mar 02, 1990
SULTAN PERIO-SELECT IRRIGATION SYSTEM
K896826
Sultan Chemists, Inc.
Dental · 88d
Cleared Mar 02, 1990
IVAC MODEL 2090 INFRA RED THERMOMETER
K896914 · FLL
Y
General Hospital · 81d
Cleared Mar 02, 1990
CMW CEMENT PRESSURISATION SYSTEM
K897134 · KIH
Dentsply Intl.
Orthopedic · 65d
Cleared Mar 02, 1990
DEXTROLYTE II, MANUAL ADMINISTRATION SET 48-1032-1
K900005 · KDJ
National Medical Care, Medical...
Gastroenterology & Urology · 59d
Cleared Mar 02, 1990
APOLIPOPROTEIN B (APO B)
K900124 · DEL
Sigma Chemical Co.
Immunology · 52d