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
83473–83496 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 2000
AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
K000159 · IXK
Agfa Corp.
Radiology · 28d
Cleared Feb 16, 2000
SYNERGY VLS CAP NUT MODELS 2206, 6102
K000236 · MNI
Interpore Cross Intl.
Orthopedic · 20d
Cleared Feb 16, 2000
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES...
K000242 · MEH
Exactech, Inc.
Orthopedic · 20d
Cleared Feb 16, 2000
ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT...
K000295 · KGO
Ansell Perry
General Hospital · 16d
Cleared Feb 16, 2000
IMPACT MODULAR TOTAL HIP SYSTEM
K000334 · LPH
Biomet, Inc.
Orthopedic · 13d
Cleared Feb 16, 2000
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA...
K000379 · DTM
Medtronic Vascular
Cardiovascular · 9d
Cleared Feb 16, 2000
ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION
K981936 · DQX
Advanced Biomedical Devices, Inc.
Cardiovascular · 624d
Cleared Feb 16, 2000
TMC-EASY-302
K984565 · INI
Tmc Magnetics & Machinery Corp.
Physical Medicine · 420d
Cleared Feb 16, 2000
SOMAVISION
K992751 · KPQ
Varian Assoc., Inc.
Radiology · 184d
Cleared Feb 16, 2000
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
K993332 · GGC
Gradipore , Ltd.
Hematology · 135d
Cleared Feb 16, 2000
ULTRASEAL XT PLUS
K993846 · EBC
Ultradent Products, Inc.
Dental · 96d
Cleared Feb 16, 2000
VANNA BATHING SYSTEM
K993872 · ILJ
Vancare, Inc.
Physical Medicine · 93d
Cleared Feb 16, 2000
TEMPOFIT, MODEL 02693
K994012 · EBG
Detax GmbH & Co. KG
Dental · 82d
Cleared Feb 16, 2000
HARDYDISK ERYTHROMYCIN, 15MCG
K994135 · JTN
Hardy Diagnostics
Microbiology · 71d
Cleared Feb 16, 2000
HARDYDISK NORFLOXACIN, 10MCG
K994150 · JTN
Hardy Diagnostics
Microbiology · 70d
Cleared Feb 16, 2000
CASTLE SERIES 100HC STEAM STERILIZERS
K994314 · FLE
Getinge/Castle, Inc.
General Hospital · 56d
Cleared Feb 16, 2000
MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM
K994425 · HRX
Endius, Inc.
Orthopedic · 48d
Cleared Feb 16, 2000
HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT...
K994432 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 48d
Cleared Feb 15, 2000
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
K000116 · JJY
Consolidated Technologies, Inc.
Chemistry · 32d
Cleared Feb 15, 2000
LIGHTSPEED 2.0CT SCANNER SYSTEM
K000300 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Feb 15, 2000
VOYAGER 6.0 SOFTWARE OPTION
K000310 · HAW
Philips Medical Systems (Cleveland),...
Neurology · 14d
Cleared Feb 15, 2000
QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF...
K991395 · MQL
Advanced Reproductive Technologies
Obstetrics & Gynecology · 300d
Cleared Feb 15, 2000
WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L
K991396 · MQL
Sage Biopharma
Obstetrics & Gynecology · 300d
Cleared Feb 15, 2000
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K992662 · MSJ
Bayer Corp.
Chemistry · 190d