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
47185–47208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2011
EASYMAX T1 SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS10042
K102345 · NBW
Eps Bio Technology Corp.
Chemistry · 306d
Cleared Jun 21, 2011
TENSCARE ITOUCH SURE MODEL ITS
K103698 · KPI
Tenscare, Ltd.
Gastroenterology & Urology · 183d
Cleared Jun 21, 2011
QLAB 8.1 QUANTIFICATION SOFTWARE
K110414 · LLZ
Philips Ultrasound, Inc.
Radiology · 127d
Cleared Jun 21, 2011
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
K110805 · OBT
Orthofix, Inc.
Orthopedic · 90d
Cleared Jun 21, 2011
ANASCIENT BREATH MONITOR
K110810 · BZL
Invoy Technologies, LLC
Anesthesiology · 90d
Cleared CT Jun 21, 2011
CT-GUIDE NEEDLE GUIDANCE SYSTEM
K110812 · JAK
Activiews, Ltd.
Radiology · 90d
Cleared Jun 21, 2011
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO
K110830 · CIX
Elitechgroup
Chemistry · 88d
Cleared Jun 21, 2011
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
K110831 · LXB
Sonitus Medical, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 21, 2011
ICEROD PLUS 17G CRYOABLATION NEEDLE, ICEROD PLUS 17G 90* CRYOABLATION NEEDLE
K110946 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 78d
Cleared Jun 20, 2011
BIOMATE STERILE ACUPUNCTURE NEEDLE
K103061 · MQX
Biomate Medical Devices Technology...
General Hospital · 245d
Cleared Jun 20, 2011
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
K110402 · FTM
Cook Biotech, Inc.
General & Plastic Surgery · 129d
Cleared Jun 20, 2011
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
K110509 · LIH
Everyway Medical Instruments Co.,Ltd
Neurology · 118d
Cleared Jun 20, 2011
IND ONE STEP HCG URINE PREGNANCY TEST (STRIP)
K110889 · LCX
Ind Diagnostics, Inc.
Chemistry · 82d
Cleared Jun 20, 2011
CENTRIMAG RETURN CANNULA KIT
K110980 · DWF
Levitronix, LLC
Cardiovascular · 74d
Cleared Jun 20, 2011
CENTRIMAG DRAINAGE CANNULA KIT
K110983 · DWF
Levitronix, LLC
Cardiovascular · 74d
Cleared Jun 20, 2011
NUVASIVE LONG LATERAL SPINAL SYSTEM
K111410 · KWQ
Nuvasive, Inc.
Orthopedic · 32d
Cleared Jun 17, 2011
FIXTEMP C&B
K102917 · EBG
Exacta Dental Direct, Inc.
Dental · 259d
Cleared Jun 17, 2011
MEDLINE EPIDURAL AND SPINAL NEEDLES
K110194 · BSP
Medline Industries, Inc.
Anesthesiology · 144d
Cleared Jun 17, 2011
NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE
K110291 · ODC
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 136d
Cleared Jun 17, 2011
SAFETYMATE TALKING FIRST AID
K110625 · OVR
Safetymate, Inc.
General Hospital · 105d
Cleared Jun 17, 2011
PRISMAFLEX
K110823 · KDI
Gambro Renal Products, Inc.
Gastroenterology & Urology · 85d
Cleared Jun 17, 2011
FIT CHECKER ADVANCED
K110871 · ELW
GC America, Inc.
Dental · 80d
Cleared Jun 17, 2011
ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
K111086 · HRS
OrthoPediatrics Corp.
Orthopedic · 59d
Cleared Jun 17, 2011
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
K111131 · IKT
Carefusion 209, Inc.
Neurology · 57d