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
41377–41400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2013
FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE
K130169 · HRX
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 97d
Cleared May 01, 2013
ATLANTIS STRAUMANN BONE LEVEL ABUTMENT
K130216 · NHA
Dentsply Implant
Dental · 92d
Cleared May 01, 2013
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE...
K130434 · MAX
Exactech, Inc.
Orthopedic · 69d
Cleared May 01, 2013
MAC-LAB HEMODYNAMIC RECORDING SYSTEM
K130626 · DQK
Ge Medical Systems Information...
Cardiovascular · 54d
Cleared May 01, 2013
BIOLOX DELTA CERAMIC FEMORAL HEADS
K130899 · LZO
Zimmer GmbH
Orthopedic · 30d
Cleared May 01, 2013
VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
K130968 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 23d
Cleared Apr 30, 2013
DEPUY M-SPEC 36MM FEMORAL HEADS
K120599 · LPH
Depuy Orthopaedics
Orthopedic · 427d
Cleared Apr 30, 2013
ZUGA DENTAL IMPLANT SYSTEM
K122664 · DZE
Zuga Medical, Inc.
Dental · 242d
Cleared Apr 30, 2013
NMI PORT
K122767 · LJT
Navilyst Medical, Inc.
General Hospital · 232d
Cleared Apr 30, 2013
CDR SYSTEMS PRECISION PATIENT POSITIONING SYSTEM
K122888 · IYE
Cdr Systems, Inc.
Radiology · 222d
Cleared Apr 30, 2013
PEREGRINE 23GA CURVED LASER PROBE
K122905 · HQB
Peregrine Surgical , Ltd.
Ophthalmic · 221d
Cleared Apr 30, 2013
STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126
K122945 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 218d
Cleared Apr 30, 2013
KOBOLD SURE-GUIDE VAGINAL CYLINDER SET, STUMP VAGINAL CYLINDER SET, MIAMI...
K123941 · JAQ
Spencer Fillmore
Radiology · 131d
Cleared Apr 30, 2013
NEUROSTAR TMS THERAPY SYSTEM
K130233 · OBP
Neuronetics
Neurology · 90d
Cleared Apr 30, 2013
MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER
K130518 · FOZ
Luther Needlesafe Products, Inc.
General Hospital · 62d
Cleared Apr 30, 2013
WVSM (WIRLESS VITAL SIGNS MONITOR)
K130957 · MWI
Athena Gtx
Cardiovascular · 25d
Cleared Apr 29, 2013
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
K123421 · NEZ
Olympus Medical Systems Corp.
Gastroenterology & Urology · 174d
Cleared Apr 29, 2013
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE
K123470 · DJZ
Pas Systems International, Inc.
Toxicology · 167d
Cleared Apr 29, 2013
REFLOW ASPIRATION CATHETER
K123482 · QEZ
Volcano Corporation
Cardiovascular · 167d
Cleared Apr 29, 2013
SINGLE USE REPOSITIONABLE CLIP
K123601 · PKL
Olympus Medical Systems Corp.
Gastroenterology & Urology · 159d
Cleared Apr 29, 2013
IRIS ANTERIOR CERVICAL PLATE
K130202 · KWQ
Life Spine, Inc.
Orthopedic · 91d
Cleared Apr 29, 2013
STRAUMANN DENTAL IMPLANT SYSTEM
K130222 · DZE
Straumann USA, LLC
Dental · 90d
Cleared Apr 29, 2013
DIAGNOSTICPRO EDGE
K130406 · LMA
Vidar Systems Corp.
Radiology · 69d
Cleared Apr 29, 2013
COMBAT READY CLAMP
K130482 · DXC
Combat Medical Systems, LLC
Cardiovascular · 63d