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
86953–86976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 08, 1999
GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL...
K982272 · DQX
Biotronik, Inc.
Cardiovascular · 193d
Cleared Jan 08, 1999
EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC...
K982754 · FWF
A.Stein - Regulatory Affairs Consulting
General & Plastic Surgery · 155d
Cleared Jan 08, 1999
KSEA MONOPOLAR VAPORIZATION ELECTRODES
K983569 · HIH
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 87d
Cleared Jan 08, 1999
STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS
K983574 · EGS
Dentalez Group
Dental · 87d
Cleared Jan 08, 1999
LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS
K983607 · MML
Labtician Ophthalmics, Inc.
Ophthalmic · 86d
Cleared Jan 08, 1999
MANAN SPINAL NEEDLES
K983620 · BSP
Manan Medical Products, Inc.
Anesthesiology · 85d
Cleared Jan 08, 1999
JMS DIALYZER PRIMING SET
K983707 · KOC
Jms Co., Ltd.
Gastroenterology & Urology · 79d
Cleared Jan 08, 1999
ULTRAFREE TEXTURED STERILE LATEX POWDER-FREE SURGICAL GLOVES
K983962 · KGO
Cardinal Health-Medical Products and...
General Hospital · 63d
Cleared Jan 08, 1999
UNIFINE
K983994 · FMF
Owen Mumford USA, Inc.
General Hospital · 60d