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
47401–47424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2011
GELPOINT PATH
K110792 · FER
Applied Medical Resources Corp.
Gastroenterology & Urology · 63d
Cleared May 23, 2011
SELECTRA IC-50-60, SELECTRA IC-50-75, SELECTRA IC-90-65, SELECTRA IC-90-75
K111154 · DQY
Biotronik, Inc.
Cardiovascular · 28d
Cleared May 20, 2011
ABS BLOWER, ABS NOZZLE, MODEL 1001
K092801 · ORC
Nimbic Systems, LLC
General Hospital · 616d
Cleared May 20, 2011
EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
K101090 · CJE
Medica Corp.
Chemistry · 396d
Cleared May 20, 2011
RMS SUBCUTANEOUS NEEDLE SET
K102512 · FPA
Repro-Med Systems, Inc.
General Hospital · 261d
Cleared May 20, 2011
NUCLISENS EASYQ MRSA
K102740 · NQX
bioMerieux, Inc.
Microbiology · 240d
Cleared May 20, 2011
CORELEADER COLLA-PAD MODEL CS 03030
K102946 · KGN
Coreleader Biotech Co., Ltd.
General & Plastic Surgery · 228d
Cleared May 20, 2011
GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT
K102970 · KCT
Gyrus Acmi, Inc.
General Hospital · 226d
Cleared May 20, 2011
EXSALT SD7 WOUND DRESSING
K103067 · FRO
Exciton Technologies, Inc.
General & Plastic Surgery · 214d
Cleared May 20, 2011
JBAIDS Q FEVER DETECTION KIT
K103207 · OVF
Idaho Technology, Inc.
Microbiology · 200d
Cleared May 20, 2011
INTERCONTINENTAL PLATE-SPACER
K103382 · OVD
Globus Medical, Inc.
Orthopedic · 183d
Cleared May 20, 2011
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
K103603 · MYF
Zeus Scientific, Inc.
Microbiology · 163d
Cleared May 20, 2011
SICAT IMPLANT V1.2
K103723 · LLZ
Sicat GmbH & Co. KG
Radiology · 150d
Cleared May 20, 2011
K2M COCR WIRE
K103797 · JDQ
K2m, Inc.
Orthopedic · 144d
Cleared May 20, 2011
HYPOTHERMX INTRAVENOUS FLUID WARMER
K103801 · LGZ
Emit Corporation
General Hospital · 143d
Cleared May 20, 2011
PHOENIX HEMODIALYSIS DELIVERY SYSTEM
K103832 · KDI
Gambro Renal Products, Inc.
Gastroenterology & Urology · 141d
Cleared May 20, 2011
VITALSENS, AINGEAL, V-POD
K110015 · MHX
Intelesens Limited
Cardiovascular · 137d
Cleared May 20, 2011
CLEARCUT S SAFETY KNIFE
K110166 · HNN
Alcon Research, Ltd.
Ophthalmic · 120d
Cleared May 20, 2011
CANNABINOIDS URINE TEST
K110182 · LDJ
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 119d
Cleared May 20, 2011
LIFTKAR PT
K110495 · ING
Sano Transportgerate GmbH
Physical Medicine · 87d
Cleared May 20, 2011
MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM
K110578 · FIP
Mar Cor Purification, Inc.
Gastroenterology & Urology · 80d
Cleared May 20, 2011
SURESIGNS VSI VITAL SIGNS MONITOR
K110803 · DXN
Philips Medical Systems
Cardiovascular · 58d
Cleared May 20, 2011
WITHINGS BLOOD PRESSURE MONITOR
K110872 · DXN
Withings
Cardiovascular · 52d
Cleared May 20, 2011
SYNGO NEURO PBV-IR
K111052 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 35d