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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
56521–56544 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 2008
NRG TRANSSEPTAL NEEDLE
K073326 · DXF
Baylis Medical Co., Inc.
Cardiovascular · 183d
Cleared May 28, 2008
HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862,...
K080424 · NLF
Hygia Health Services, Inc.
Anesthesiology · 103d
Cleared May 28, 2008
UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE...
K080551 · JOW
University of Utah Hospitals and Clinics
Cardiovascular · 90d
Cleared May 28, 2008
VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR...
K080934 · JAQ
Nucletron Corporation
Radiology · 56d
Cleared May 28, 2008
DESTINATION RENAL GUIDING SHEATH
K081045 · DYB
Terumo Medical Corp.
Cardiovascular · 44d
Cleared May 28, 2008
PARIETEX PROGRIP MESH
K081050 · FTL
Sofradim Production
General & Plastic Surgery · 44d
Cleared May 28, 2008
PROSTATE TISSUE MARKER
K081170 · NEU
Senorx, Inc.
General & Plastic Surgery · 34d
Cleared May 28, 2008
REVERE UNIPLANAR SCREWS
K081195 · NKB
Globus Medical, Inc.
Orthopedic · 30d
Cleared May 28, 2008
WBR XPRESS3.CARDIAC
K081201 · KPS
Ultraspect , Ltd.
Radiology · 30d
Cleared May 28, 2008
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
K081203 · HGM
Philips Medizin Systeme Boeblingen GmbH
Obstetrics & Gynecology · 30d
Cleared May 28, 2008
MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER
K081220 · PNO
Angioscore, Inc.
Cardiovascular · 28d
Cleared May 28, 2008
SURESKIN SILVER BANDAGES
K081274 · FRO
Euromed, Inc.
General & Plastic Surgery · 23d
Cleared May 28, 2008
ILUMA VISION
K081347 · LLZ
Imtec Corp.
Radiology · 14d
Cleared May 27, 2008
WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H
K081256 · FLL
Rio Flexon Technology Co., Ltd.
General Hospital · 25d
Cleared May 27, 2008
DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K081320 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 15d
Cleared May 23, 2008
TARRY MEDICAL TEMPERATURE PROBES
K071977 · FMZ
Tarry Medical Products, Inc.
General Hospital · 311d
Cleared May 23, 2008
DEL SOL RED LIGHT THERAPY SYSTEM
K072399 · ILY
Edge Systems, Inc.
Physical Medicine · 270d
Cleared May 23, 2008
ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM
K072564 · GEX
Alma Lasers , Ltd.
General & Plastic Surgery · 255d
Cleared May 23, 2008
ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES
K072859 · GAM
Internacional Farmaceutica, S.A. DE C.V.
General & Plastic Surgery · 231d
Cleared May 23, 2008
ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
K072863 · GAM
Internacional Farmaceutica, S.A. DE C.V.
General & Plastic Surgery · 231d
Cleared May 23, 2008
VAR MONITOR
K073261 · BTL
Vortran Medical Technology 1, Inc.
Anesthesiology · 185d
Cleared May 23, 2008
MROPEN
K073362 · LNH
Paramed S.R.L.
Radiology · 175d
Cleared May 23, 2008
NEMUS SYSTEM
K073415 · IKN
Eb Neuro S.P.A.
Neurology · 171d
Cleared May 23, 2008
SPINEASSIST SYSTEM
K073467 · HAW
Mazor Surgical Technologies , Ltd.
Neurology · 165d