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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
43057–43080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 2012
DRAGON LW
K121410 · IZL
Sedecal., Sa.
Radiology · 83d
Cleared Aug 02, 2012
PERIFUSE CATHETER
K121525 · CAZ
Smiths Medical Asd, Inc.
Anesthesiology · 71d
Cleared Aug 02, 2012
SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS
K121867 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 37d
Cleared Aug 02, 2012
LANX SPINAL FIXATION SYSTEM
K121940 · NKB
Lanx, Inc.
Orthopedic · 31d
Cleared Aug 02, 2012
ELI 280 ELECTROCARDIOGRAPH
K122073 · DPS
Mortara Instrument, Inc.
Cardiovascular · 17d
Cleared Aug 02, 2012
PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
K122121 · DXG
Pulsion Medical Systems SE
Cardiovascular · 16d
Cleared Aug 01, 2012
ORION MICRO CATHETER
K113289 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 268d
Cleared Aug 01, 2012
CELOX GAUZE PRO
K113560 · QSY
Medtrade Products , Ltd.
General & Plastic Surgery · 244d
Cleared Aug 01, 2012
SOLAR GI
K121014 · FFX
Medical Measurement Systems B.V.
Gastroenterology & Urology · 120d
Cleared Aug 01, 2012
MEDILAS H RFID LASER FIBER
K121938 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 30d
Cleared Aug 01, 2012
WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO...
K121987 · DKZ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 26d
Cleared Jul 31, 2012
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
K112545 · MOB
Inova Diagnostics, Inc.
Immunology · 334d
Cleared Jul 31, 2012
VIDAS D-DIMER EXCLUSION II (DEX2)
K112818 · DAP
bioMerieux, Inc.
Hematology · 307d
Cleared Jul 31, 2012
STENTUBE LACRIMAL INTUBATION SET
K113118 · OKS
Quest Medical, Inc.
Ophthalmic · 284d
Cleared Jul 31, 2012
HQS INTRODUCER
K113849 · DYB
Alseal
Cardiovascular · 215d
Cleared Jul 31, 2012
DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT
K120283 · EMA
Novocol, Inc.
Dental · 182d
Cleared Jul 31, 2012
OSSEOSPEED PLUS
K120414 · DZE
Astra Tech AB
Dental · 172d
Cleared Jul 31, 2012
VICTUS LASER PLATFORM
K120426 · OOE
Technolas Perfect Vision GmbH
Ophthalmic · 169d
Cleared Jul 31, 2012
SYNTHES MATRIX SYSTEM
K120838 · NKB
Synthes Spine
Orthopedic · 133d
Cleared Jul 31, 2012
DIAZYME HOMOCYSTEINE POC TEST KIT
K121053 · LPS
Diazyme Laboratories
Chemistry · 116d
Cleared Jul 31, 2012
ATOM 1 (MODEL: BRC 2200)
K121578 · GZJ
Bioelectric Research Corporation
Neurology · 62d
Cleared Jul 30, 2012
KEVO NPWT-AHEMO30 AND A HEMO45 FOAM DRESSING KIT
K113199 · OMP
Kevo Medical Supplies
General & Plastic Surgery · 273d
Cleared Jul 30, 2012
SPINAL ELEMENTS POSTERIOR CERVICAL/THORACIC SPINAL SYSTEM
K120467 · NKB
Spinal Elements, Inc.
Orthopedic · 166d
Cleared Jul 30, 2012
AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM
K120511 · NFO
Leto Enterprise , Ltd.
Neurology · 160d