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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
117865–117888 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 04, 1992
COAGULATION ARPR,CAT.NO.5185
K914949 · GGN
Helena Laboratories
Hematology · 121d
Cleared Mar 04, 1992
KALLESTAD ROTAVIRUS MICROPLATE
K915137 · LIQ
Bio-Rad Laboratories, Inc.
Microbiology · 112d
Cleared Mar 04, 1992
GAP IGG H.PYLORI MODIFIED
K915185 · LYR
Biomerica, Inc.
Microbiology · 107d
Cleared Mar 04, 1992
SARNS RETROGRADE CANNULA
K915193 · DWF
3M Health Care, Sarns
Cardiovascular · 106d
Cleared Mar 04, 1992
INTRAOSSEOUS ACCESS NEEDLE
K915409 · FMI
Cook, Inc.
General Hospital · 93d
Cleared Mar 04, 1992
MEDICAL SUNLAMP FOR PHOTOTHERAPY
K915426 · FTC
American Sunlight, Inc.
General & Plastic Surgery · 93d
Cleared Mar 04, 1992
FIBRINOGEN CONTROL
K915462 · GIL
Sigma Diagnostics, Inc.
Hematology · 91d
Cleared Mar 04, 1992
PERFECTA PDA TOTAL HIP SYSTEM
K915795 · JDI
Orthomet, Inc.
Orthopedic · 65d
Cleared Mar 04, 1992
VIDAS CHLAMYDIA ASSAY, MODIFICATION
K915884 · LJC
Vitek Systems, Inc.
Microbiology · 83d
Cleared Mar 04, 1992
TOXO IGG ELISA TEST (MODIFIED)
K915891 · LGD
Gull Laboratories, Inc.
Microbiology · 71d
Cleared Mar 04, 1992
RUBELLA IGG ELISA TEST
K915893 · LFX
Gull Laboratories, Inc.
Microbiology · 71d
Cleared Mar 04, 1992
OPTI-LENS CONTACT LENS CASE
K920064 · LRX
Ryder Intl. Corp.
Ophthalmic · 57d
Cleared Mar 04, 1992
URINE A CALIBRATOR
K920208 · DKB
Diagnostic Reagents, Inc.
Toxicology · 48d
Cleared Mar 04, 1992
MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT
K920299 · CFL
Medix Biotech, Inc.
Chemistry · 42d
Cleared Mar 04, 1992
MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD
K920336 · CIT
Heraeus Kulzer, Inc.
Chemistry · 40d
Cleared Mar 03, 1992
BLADDERSCAN BVI 2500
K915436 · IYO
Diagnostic Ultrasound Corp.
Radiology · 90d
Cleared Mar 02, 1992
CW DOPPLER 2.25 MHZ PROBE
K903562 · ITX
Diasonics, Inc.
Radiology · 573d
Cleared Mar 02, 1992
SR-ISOSIT SPECTRA LINK SYSTEM
K910069 · KLE
Ivoclar North America, Inc.
Dental · 418d
Cleared Mar 02, 1992
CRITIC-AID WOUND DRESSING
K912506 · KMF
Sween Corp.
General & Plastic Surgery · 270d
Cleared Mar 02, 1992
MINI-MILL
K914035 · EMI
Biomedical Composites, Ltd.
Dental · 174d
Cleared Mar 02, 1992
OPTICAL VALVULOTOME
K914385 · MGZ
Intramed Laboratories, Inc.
Cardiovascular · 153d
Cleared Mar 02, 1992
RETINA TESTER
K914393 · HLX
Retina Tester
Ophthalmic · 153d
Cleared Mar 02, 1992
VITAPAN ACRYLIC DENTURE TEETH
K914476 · ELM
Vident
Dental · 146d
Cleared Mar 02, 1992
KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM
K914728 · LMB
Eastman Kodak Company
Radiology · 133d