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
87457–87480 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 1999
AMPLAID A311 SERIES
K983712 · EWO
Amplifon S.P.A.
Ear, Nose, Throat · 83d
Cleared Jan 12, 1999
STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
K984000 · LMD
Surgical Navigation Technologies, Inc.
Radiology · 63d
Cleared Jan 12, 1999
MEDRAD QUADRATURE CTL ARRAY COIL
K984159 · MOS
Medrad, Inc.
Radiology · 54d
Cleared Jan 12, 1999
SAGE 7
K984167 · LNI
GE Medical Systems
Radiology · 53d
Cleared Jan 12, 1999
OLYMPUS HX-20 SERIES LIGATING DEVICE
K984255 · MND
Olympus Corp of America
Gastroenterology & Urology · 43d
Cleared Jan 12, 1999
MODIFICATION OF: RHEO DOPPLEX II
K984307 · IYN
Huntleigh Healthcare, Inc.
Radiology · 41d
Cleared Jan 11, 1999
STERRAD 50 STERILIZER
K981625 · MLR
Advanced Sterilization Products
General Hospital · 249d
Cleared Jan 11, 1999
GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
K983399 · MHI
Genzyme Diagnostics
Microbiology · 105d
Cleared Jan 11, 1999
IMCOR 4.00 & 5.00MM SELF-TAPPING LOCKTITE IMPLANTS, IMCOR 4.00 & 5.00MM...
K983563 · DZE
Imcor
Dental · 90d
Cleared Jan 11, 1999
3-CHIP VIDEO CAMERA
K983566 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 90d
Cleared Jan 11, 1999
NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K983597 · GXZ
Medicotest, Inc.
Neurology · 90d
Cleared Jan 11, 1999
S555 INTRAORAL DENTAL CAMERA
K983625 · EIA
Sopro
Dental · 88d
Cleared Jan 11, 1999
JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
K983635 · BSZ
Draeger Medical, Inc.
Anesthesiology · 88d
Cleared Jan 11, 1999
DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT...
K983849 · JHM
Dade Behring, Inc.
Chemistry · 73d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST...
K984123 · LHL
Zeus Scientific, Inc.
Microbiology · 54d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN...
K984126 · MCD
Zeus Scientific, Inc.
Microbiology · 54d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN...
K984133 · LLM
Zeus Scientific, Inc.
Microbiology · 54d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME...
K984139 · LFZ
Zeus Scientific, Inc.
Microbiology · 54d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
K984153 · LJZ
Zeus Scientific, Inc.
Microbiology · 53d
Cleared Jan 11, 1999
INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000
K984444 · FFX
Sandhill Scientific, Inc.
Gastroenterology & Urology · 28d
Cleared Jan 11, 1999
COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K984456 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 27d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME...
K984516 · MOB
Zeus Scientific, Inc.
Immunology · 24d
Cleared Jan 08, 1999
LIDCO SYSTEM
K962918 · DXG
Lidco, Ltd.
Cardiovascular · 925d
Cleared Jan 08, 1999
TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER
K982181 · CAF
Trudell Medical
Anesthesiology · 200d