Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
43993–44016 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 2012
CARBONAID C02 DIFFUSER
K112975 · HIF
Cardia Innovation AB
Obstetrics & Gynecology · 261d
Cleared Jun 22, 2012
PENTAX EPK-I5020 VIDEO PROCESSOR
K113873 · FET
Pentax of America, Inc.
Gastroenterology & Urology · 175d
Cleared Jun 22, 2012
EMG RECORDING ELECTRODE ASSEMBLY
K120342 · IKT
Rhythmlink International, LLC
Neurology · 140d
Cleared Jun 22, 2012
CRYO-TOUCH III
K120415 · GXH
Myoscience, Inc.
Neurology · 133d
Cleared Jun 22, 2012
QUANTRA
K120472 · LLZ
Hologic, Inc.
Radiology · 127d
Cleared Jun 22, 2012
INSULIN PEN NEEDLE
K120690 · FMI
Tiger Medical Products, Ltd.
General Hospital · 107d
Cleared Jun 22, 2012
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT
K120959 · MXJ
Bio-Rad Laboratories
Microbiology · 84d
Cleared Jun 22, 2012
CS 8100 CS 8100 ACCESS
K120975 · MUH
Trophy
Radiology · 81d
Cleared Jun 22, 2012
BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN
K121018 · MBI
Smith & Nephew, Inc.
Orthopedic · 79d
Cleared Jun 22, 2012
TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER
K121222 · LOX
Abbott Vascular
Cardiovascular · 60d
Cleared Jun 22, 2012
XIA 4.5 SPINAL SYSTEM
K121342 · NKB
Stryker Corp.
Orthopedic · 49d
Cleared Jun 22, 2012
SYNGO.MR NEUROLOGY
K121459 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 36d
Cleared Jun 22, 2012
EUROTROL GAS-ISE METABOLITES
K121468 · JJY
Eurotrol B.V.
Chemistry · 36d
Cleared Jun 22, 2012
HERO GRAFT
K121532 · DSY
Hemosphere, Inc.
Cardiovascular · 29d
Cleared Jun 22, 2012
APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
K121577 · IYN
Toshiba Medical Systems Corporation,...
Radiology · 23d
Cleared Jun 22, 2012
ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND...
K121646 · IYN
Siemens Medical Solutions USA, Inc....
Radiology · 17d
Cleared Jun 22, 2012
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND...
K121699 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Jun 21, 2012
QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER
K112824 · CAF
Quality Life Technologies Co;Ltd
Anesthesiology · 267d
Cleared Jun 21, 2012
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
K113277 · LJS
Arrow International, Inc.
General Hospital · 227d
Cleared Jun 21, 2012
OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
K113566 · NDS
Life Technologies, Inc.
Gastroenterology & Urology · 202d
Cleared Jun 21, 2012
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
K120245 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 146d
Cleared Jun 21, 2012
EASYDEX
K120247 · MRV
Vineland Syrup, Inc.
Chemistry · 146d
Cleared Jun 21, 2012
PROCOLL
K120339 · KGN
Innocoll Pharmaceuticals
General & Plastic Surgery · 139d
Cleared Jun 21, 2012
SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM
K120524 · FFX
Mui Scientific
Gastroenterology & Urology · 120d