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
69769–69792 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 17, 2004
RTIST
K033955 · LLZ
Mirada Solutions , Ltd.
Radiology · 86d
Cleared Mar 17, 2004
NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM
K040039 · LLZ
Barco N.V.
Radiology · 68d
Cleared Mar 17, 2004
PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS...
K040119 · FTM
Synovis Surgical Innovations
General & Plastic Surgery · 57d
Cleared Mar 17, 2004
DERMAWAVE 5000 COMBI MAX SYSTEM
K040121 · IMG
Dermawave, LLC
Physical Medicine · 57d
Cleared Mar 17, 2004
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING...
K040408 · LYY
Shun Thai Rubber Gloves Industry...
General Hospital · 29d
Cleared Mar 17, 2004
VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD
K040510 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 19d
Cleared Mar 17, 2004
BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
K040538 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 15d
Cleared Mar 17, 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040558 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 14d
Cleared Mar 16, 2004
POWERLITE 600 EX SYSTEM
K033933 · GEX
Preswede AB
General & Plastic Surgery · 88d
Cleared Mar 16, 2004
SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE
K034012 · GXI
Smith & Nephew, Inc.
Neurology · 83d
Cleared Mar 16, 2004
PLV CONTINUUM VENTILATOR, MODEL P2000
K034032 · NOU
Respironics California, Inc.
Anesthesiology · 78d
Cleared Mar 16, 2004
CORRESTORE PATCH SYSTEM
K040162 · DXZ
Somanetics Corp.
Cardiovascular · 50d
Cleared Mar 16, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER
K040492 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 19d
Cleared Mar 16, 2004
ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE,...
K040503 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 18d
Cleared Mar 16, 2004
ZILVER 635 BILIARY STENT
K040505 · FGE
Cook, Inc.
Gastroenterology & Urology · 18d
Cleared Mar 16, 2004
LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
K040550 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 14d
Cleared Mar 15, 2004
RESTFUL NIGHTS, IST-APPLIANCE
K021569 · LRK
Ottawa Dental Laboratory
Dental · 671d
Cleared Mar 15, 2004
APEX NRG
K032743 · LQY
Medicnrg , Ltd.
Dental · 193d
Cleared Mar 15, 2004
SERRALAPG
K033762 · GAM
Serral, S.A. DE C.V.
General & Plastic Surgery · 104d
Cleared Mar 15, 2004
BLACK COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
K034052 · LZA
Latexx Manufacturing Sdn.Bhd.
General Hospital · 76d
Cleared Mar 15, 2004
ANSPACH ADVANCED MICRO SAW ATTACHMENTS
K040076 · HBE
The Anspach Effort, Inc.
Neurology · 61d
Cleared Mar 15, 2004
ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFS
K040286 · DXQ
Ethox Corp.
Cardiovascular · 38d
Cleared Mar 15, 2004
ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
K040298 · DXT
Acist Medical Systems, Inc.
Cardiovascular · 35d
Cleared Mar 15, 2004
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHANGER WITH GBS...
K040355 · DTR
Gish Biomedical, Inc.
Cardiovascular · 32d