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
66193–66216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 2005
FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT...
K043500 · BSP
Innospine, Inc.
Anesthesiology · 116d
Cleared Apr 15, 2005
THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10
K050101 · HRS
Zimmer Trabecular
Orthopedic · 87d
Cleared Apr 15, 2005
SPIRIT, MODEL HAS
K050153 · BYJ
Caire, Inc.
Anesthesiology · 81d
Cleared Apr 15, 2005
SPECTRA-SP CO2 LASER SYSTEM
K050254 · GEX
Max Engineering , Ltd.
General & Plastic Surgery · 71d
Cleared Apr 15, 2005
ARTHERX CORKSCREW FT II SUTURE ANCHOR
K050358 · HWC
Arthrex, Inc.
Orthopedic · 60d
Cleared Apr 15, 2005
PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS
K050506 · DZE
Lifecore Biomedical, Inc.
Dental · 46d
Cleared Apr 15, 2005
SMARTDOP 45 VASCULAR DOPPLER
K050601 · DPW
Koven Technology, Inc.
Radiology · 37d
Cleared Apr 15, 2005
KERR VPS IMPRESSION MATERIAL
K050604 · ELW
Sybron Dental Specialties, Inc.
Dental · 37d
Cleared Apr 15, 2005
MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004
K050699 · JDK
Amedica Corp.
Orthopedic · 28d
Cleared Apr 15, 2005
MATRIX STRETCH RESISTANT (SR) COILS
K050700 · HCG
Boston Scientific Corp
Neurology · 28d
Cleared Apr 15, 2005
HARMONY PORT SYSTEM, MODEL 1907 SERIES
K050706 · GZT
Spinal Concepts, Inc.
Neurology · 28d
Cleared Apr 14, 2005
CUMULASE
K042495 · MQL
Halozyme Therapeutics, Inc.
Obstetrics & Gynecology · 212d
Cleared Apr 14, 2005
VACULINK, MODEL VCL 3000
K043614 · HDB
Medevco, Inc.
Obstetrics & Gynecology · 105d
Cleared Apr 14, 2005
VEINNOVATIONS INFILTRATION SYSTEM
K050474 · FRN
Veinnovations, LLC
General Hospital · 49d
Cleared Apr 14, 2005
THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
K050511 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 44d
Cleared Apr 14, 2005
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM...
K050532 · LYY
Spi Gloves Sdn. Bhd.
General Hospital · 43d
Cleared Apr 14, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML
K050555 · LON
Becton, Dickinson & CO
Microbiology · 42d
Cleared Apr 14, 2005
OCULIGHT GL/GLX
K050562 · GEX
Iridex Corp
General & Plastic Surgery · 42d
Cleared Apr 14, 2005
QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM...
K050769 · QSY
Z-Medica Corporation
General & Plastic Surgery · 20d
Cleared Apr 14, 2005
MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT
K050770 · MEB
Mckinley Medical, LLC
General Hospital · 20d
Cleared Apr 14, 2005
SYNGO BODY PERFUSION-CT
K050867 · JAK
Siemens AG
Radiology · 8d
Cleared Apr 13, 2005
SIC PRO
K040757 · DZE
Sic Invent AG
Dental · 384d
Cleared Apr 13, 2005
RELIANT STENT GRAFT BALLOON CATHETER
K050038 · DQY
Medtronic Endovascular Innovations
Cardiovascular · 96d
Cleared Apr 13, 2005
REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S
K050046 · IPF
Compex Technologies, Inc.
Physical Medicine · 93d