FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
77953–77976 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT
K013077 · MSV
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
K013079 · MSV
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
K013080 · MSV
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
ADC COMPACT PLUS
K013138 · MQB
Agfa-Gevaert AG
Radiology · 9d
Cleared Sep 28, 2001
TE ME NA POLYSTIM NERVE STIMILATOR
K990323 · BXN
Te ME NA S.A.R.L.
Anesthesiology · 969d
Cleared Sep 27, 2001
SLENDERTONE FLEX, MODEL, 512
K010335 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 237d
Cleared Sep 27, 2001
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS...
K010478 · DTZ
Dideco
Cardiovascular · 219d
Cleared Sep 27, 2001
DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
K010712 · FID
Molded Products, Inc.
Gastroenterology & Urology · 202d
Cleared Sep 27, 2001
VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)
K010732 · MWI
Telemedic Systems, Inc.
Cardiovascular · 199d
Cleared Sep 27, 2001
EXEL INJECTION PLUG WITH CAP
K011405 · FPA
Exelint Intl. Co.
General Hospital · 142d
Cleared Sep 27, 2001
VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
K011800 · NLU
Vanguard Medical Concepts, Inc.
Gastroenterology & Urology · 111d
Cleared Sep 27, 2001
PF2
K012062 · KTT
Fixano SA
Orthopedic · 87d
Cleared Sep 27, 2001
RADIOFIX
K012078 · KTT
Fixano SA
Orthopedic · 87d
Cleared Sep 27, 2001
COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408
K012160 · EBF
Premier Dental Products Co.
Dental · 78d
Cleared Sep 27, 2001
NUMARIS 4VA15A
K012202 · LNH
Siemens Medical Corp.
Radiology · 76d
Cleared Sep 27, 2001
COLOR-MONOGEN
K012901 · KTN
Instrumentation Laboratory CO
Immunology · 29d
Cleared Sep 27, 2001
AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
K013084 · DTM
Medtronic Perfusion Systems
Cardiovascular · 13d
Cleared Sep 26, 2001
FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450...
K011877 · HKI
Carl Zeiss Jena GmbH
Ophthalmic · 103d
Cleared Sep 26, 2001
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
K011961 · LZA
Shen Wei (Usa), Inc.
General Hospital · 96d
Cleared Sep 26, 2001
BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
K011970 · CHH
Biosafe Laboratories, Inc.
Chemistry · 93d
Cleared Sep 26, 2001
SONOREAL 3D
K012084 · IYO
Bio Medi Com
Radiology · 85d
Cleared Sep 26, 2001
THE INTUITIVE COLORIMETER
K012298 · NFD
Cerium Optical Technologies, Inc.
Ophthalmic · 68d
Cleared Sep 26, 2001
URISYS 2400 URINE TEST STRIP
K012397 · JIL
Roche Diagnostics Corp.
Chemistry · 61d
Cleared Sep 26, 2001
STERILE NITRILE SURGICAL GLOVES (POWDERED)
K012479 · KGO
Smart Glove Corp. Sdn Bhd
General Hospital · 55d