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
48505–48528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 14, 2011
PROLYTE ELECTROLYTE ANALYZER
K102959 · JGS
Diamond Diagnostics, Inc.
Chemistry · 101d
Cleared Jan 14, 2011
ESG-400 MODEL WB95051N, FOOTSWITCH DOUBLE PEDAL MODEL WB50402W, FOOTSWITCH...
K103032 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 94d
Cleared Jan 14, 2011
KING COBRA ANTERIOR CERVICAL PLATE
K103068 · KWQ
Eminent Spine
Orthopedic · 88d
Cleared Jan 14, 2011
GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT
K103088 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 87d
Cleared Jan 14, 2011
TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K103182 · LLZ
Genoray Co., Ltd.
Radiology · 78d
Cleared Jan 14, 2011
MULTIPURPOSE DRAINAGE CATHETER
K103353 · FGE
Navilyst Medical, Inc.
Gastroenterology & Urology · 59d
Cleared Jan 14, 2011
ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
K103501 · GEX
Alma Lasers, Inc.
General & Plastic Surgery · 46d
Cleared Jan 14, 2011
G-PROX EZ ENDOSCOPIC GRASPER
K103688 · OCZ
Usgi Medical
Gastroenterology & Urology · 28d
Cleared Jan 13, 2011
PLATELIA ASPERGILLUS EIA MODEL 62793
K093678 · NOM
Bio-Rad
Microbiology · 412d
Cleared Jan 13, 2011
DANA EMULATING INDICATOR
K100891 · JOJ
Dana Products, Inc.
General Hospital · 288d
Cleared Jan 13, 2011
HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809
K101614 · DWL
Dm Systems, Incorporated
General Hospital · 218d
Cleared Jan 13, 2011
FETAL MONITORS, MODELS F2 AND F3
K102140 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 168d
Cleared Jan 13, 2011
AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
K102460 · BSO
Summit Medical Products, Inc.
Anesthesiology · 139d
Cleared Jan 13, 2011
FLEBOSET DOUBLE
K102590 · LHI
Laboratorios Grifols, S.A.
General Hospital · 126d
Cleared Jan 13, 2011
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K102613 · LYZ
Hebei Favor Plastic Co., Ltd.
General Hospital · 125d
Cleared Jan 13, 2011
BONASIL A+ IMPRESSION MATERIALS
K102836 · ELW
Dmp, Ltd.
Dental · 106d
Cleared Jan 13, 2011
SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE...
K102861 · KKX
A Plus International, Inc.
General Hospital · 105d
Cleared Jan 13, 2011
MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR
K102996 · FEB
Medivators Reprocessing Systems
General Hospital · 98d
Cleared Jan 13, 2011
CASPIAN SPINAL SYSTEM
K103232 · KWP
K2m, Inc.
Orthopedic · 72d
Cleared Jan 13, 2011
SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND...
K103652 · MHX
Philips Medical Systesms
Cardiovascular · 30d
Cleared Jan 12, 2011
SMARTXIDE 50 HS/MS
K101904 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 188d
Cleared Jan 12, 2011
ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR
K102121 · OVD
Apollo Spine, Inc.
Orthopedic · 167d
Cleared Jan 12, 2011
BREATHSCN PRO
K102338 · DJZ
Akers Biosciences, Inc.
Toxicology · 147d
Cleared Jan 12, 2011
MIXED MEDIA MARKER
K102506 · NEU
Cortex Manufacturing, Inc.
General & Plastic Surgery · 133d