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
76753–76776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 28, 2002
ORTHOSS RESORBABLE BONE VOID FILLER
K014289 · LYC
Geistlich-Pharma
Dental · 90d
Cleared Mar 28, 2002
ENTEC PLASMA WANDS
K014290 · GEI
Arthrocare Corp.
General & Plastic Surgery · 90d
Cleared Mar 28, 2002
UNIFIL FLOW
K020342 · EBF
GC America, Inc.
Dental · 55d
Cleared Mar 28, 2002
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY
K020441 · DIO
Dade Behring, Inc.
Toxicology · 45d
Cleared Mar 28, 2002
PBS, PBSW WITH CATIONS AND PHENOL RED
K020490 · MQL
Conception Technologies
Obstetrics & Gynecology · 43d
Cleared Mar 28, 2002
ARTHROCARE CONTROLLER
K020621 · GEY
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared Mar 28, 2002
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000)
K020622 · GEI
Arthrocare Corp.
General & Plastic Surgery · 30d
Cleared Mar 28, 2002
MODIFICATION TO SPARC SLING SYSTEM
K020663 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 27d
Cleared Mar 28, 2002
CODMAN HAKIM SHUNT SYSTEMS
K020667 · JXG
Codman & Shurtleff, Inc.
Neurology · 27d
Cleared Mar 28, 2002
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB
K020669 · DTB
Oscor, Inc.
Cardiovascular · 27d
Cleared Mar 28, 2002
HEMOCHRON JR. SIGNATURE +
K020798 · JPA
International Technidyne Corp.
Hematology · 16d
Cleared Mar 27, 2002
MRSA-SCREEN
K011400 · MYI
Denka Seiken'S
Microbiology · 324d
Cleared Mar 27, 2002
GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
K012520 · DRF
Cardiac Assist Devices, Inc.
Cardiovascular · 233d
Cleared Mar 27, 2002
GLASS POST
K012849 · ELR
J. Morita USA, Inc.
Dental · 236d
Cleared Mar 27, 2002
WIZAIR DVT
K012994 · JOW
Medical Compression Systems (Dbn) , Ltd.
Cardiovascular · 202d
Cleared Mar 27, 2002
SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
K013488 · JXG
Sophysa SA
Neurology · 159d
Cleared Mar 27, 2002
OMNI OXYGEN SYSTEM, MODEL 1000
K013931 · CAW
Sequal Technologies, Inc.
Anesthesiology · 119d
Cleared Mar 27, 2002
UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
K013949 · FPA
Churchill Medical Systems, Inc.
General Hospital · 117d
Cleared Mar 27, 2002
TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE
K014260 · GEI
Tissuelink Medical, Inc.
General & Plastic Surgery · 90d
Cleared Mar 27, 2002
NORAPAD PLAIN
K014268 · HBA
Perlei Medical, Inc.
Neurology · 90d
Cleared Mar 27, 2002
PERIOLASE ND:YAG DENTAL LASER SYSTEM
K014272 · GEX
Millennium Dental Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Mar 27, 2002
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S
K014304 · HWC
Triage Medical, Inc.
Orthopedic · 86d
Cleared Mar 27, 2002
EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006,...
K020031 · GEI
Neothermia Corp.
General & Plastic Surgery · 82d
Cleared Mar 27, 2002
PROCERA ALLCERAM BRIDGE MATERIAL
K020269 · EIH
Procera Sandvik AB
Dental · 58d