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
129985–130008 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1989
THE FERN CRYOPROBE
K892237 · GEH
Cryogenic Instruments & Equipment , Ltd.
General & Plastic Surgery · 112d
Cleared Jul 25, 1989
INJECTION PORT FOR---INTERMITTENT INJECTION
K892429 · FPA
The Medi-Dose Group
General Hospital · 106d
Cleared Jul 25, 1989
SONGER WIRING SYSTEM
K892651 · LRN
Danek Medical, Inc.
Orthopedic · 103d
Cleared Jul 25, 1989
60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE
K892906 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 96d
Cleared Jul 25, 1989
STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010
K893128 · CDL
Stanbio Laboratory
Chemistry · 91d
Cleared Jul 25, 1989
CHAIR/STOOL UNIT DENTAL OPER., PORTABLE, FIELD
K893454 · KLC
Atlantic Industries, Inc.
Dental · 83d
Cleared Jul 25, 1989
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893465 · LKQ
Immuno Concepts, Inc.
Microbiology · 83d
Cleared Jul 25, 1989
ABBOTT TESTPACK CHLAMYDIA
K893676 · LJC
Abbott Laboratories
Microbiology · 70d
Cleared Jul 25, 1989
DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM
K893775 · JQW
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 64d
Cleared Jul 25, 1989
M.F.S. LOW AIR LOSS PULSATING BED
K893801 · IOQ
Medical Flotation Systems, Inc.
Physical Medicine · 64d
Cleared Jul 25, 1989
HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS
K893815 · DKB
Hycor Biomedical, Inc.
Toxicology · 63d
Cleared Jul 25, 1989
DAU I, DAU II, DAU III AND DAU IV CONTROL URINE
K893835 · DIF
Ciba Corning Diagnostics Corp.
Chemistry · 62d
Cleared Jul 25, 1989
HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL
K893895 · JPK
Intercare Diagnostics, Inc.
Hematology · 56d
Cleared Jul 25, 1989
P.S.A. FEMORAL HIP PROSTHESIS
K893959 · KWY
Protek, Inc.
Orthopedic · 54d
Cleared Jul 25, 1989
HDL PRECIPITATING REAGENT
K893966 · LBR
Diagnostic Systems
Chemistry · 53d
Cleared Jul 25, 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II
K893970 · GGC
Analytical Control Systems, Inc.
Hematology · 53d
Cleared Jul 25, 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II
K893971 · GGC
Analytical Control Systems, Inc.
Hematology · 53d
Cleared Jul 25, 1989
NEW WEST SUNGLASSES
K893986 · HQY
New West Promotions
Ophthalmic · 50d
Cleared Jul 25, 1989
MINICLINIC PREGNANCY TEST
K894012 · JHI
Vanguard Biomedical Corp.
Chemistry · 49d
Cleared Jul 25, 1989
MODIFIED POLYCHROME IV STAIN
K894045 · KFD
Devetec, Inc.
Pathology · 48d
Cleared Jul 25, 1989
RAOMER
K894112 · INI
Niagara Corp.
Physical Medicine · 43d
Cleared Jul 25, 1989
WORLD CHAIR
K894136 · IOR
Invacare Corp.
Physical Medicine · 42d
Cleared Jul 25, 1989
ANTI-THYROGLOBULIN TEST KIT
K894203 · JZO
Kronus
Immunology · 36d
Cleared Jul 25, 1989
TECNOL SILK STRIP
K894205 · FPX
Tecnol New Jersey Wound Care, Inc.
General & Plastic Surgery · 36d