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
71497–71520 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 2003
GALIX WINTER
K030145 · DQK
Galix Biomedical Instrumentation, Inc.
Cardiovascular · 245d
Cleared Sep 17, 2003
CRESCENT TINNITUS RETAINING SOUND GENERATOR
K030180 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 243d
Cleared Sep 17, 2003
BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
K030570 · BTO
Portex , Ltd.
Anesthesiology · 205d
Cleared Sep 17, 2003
FETAL SPIRAL ELECTRODE, MODEL FSE07000
K030691 · HGP
Clinical Innovations, Inc.
Obstetrics & Gynecology · 196d
Cleared Sep 17, 2003
AKERS LABORATORIES INC. BLOOD CELL SEPARATOR
K030815 · JKA
Akers Laboratories, Inc.
Chemistry · 187d
Cleared Sep 17, 2003
SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5
K030821 · MUJ
Simuplan S.L.
Radiology · 187d
Cleared Sep 17, 2003
PRIMOSPLINT SYSTEM
K030832 · MQC
Cosmedent, Inc.
Dental · 184d
Cleared Sep 17, 2003
D-STAT-DRY HEMOSTATIC BANDAGE
K030836 · QSX
Vascular Solutions, Inc.
General & Plastic Surgery · 184d
Cleared Sep 17, 2003
SORB+HISORB+CARTRIDGE
K031099 · FKT
Renal Solutions, Inc.
Gastroenterology & Urology · 163d
Cleared Sep 17, 2003
FLEX-NECK PD CATHETER, INFANT
K031351 · FJS
Medigroup, Inc.
Gastroenterology & Urology · 141d
Cleared Sep 17, 2003
SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM
K031855 · KWQ
Spinal Concepts, Inc.
Orthopedic · 93d
Cleared Sep 17, 2003
ONLINE TDM CARBAMAZEPINE
K031902 · KLT
Roche Diagnostics Corp.
Toxicology · 89d
Cleared Sep 17, 2003
PROCEED TRILAMINATE SURGICAL MESH
K031925 · FTL
Ethicon, Inc.
General & Plastic Surgery · 86d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K031967 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Sep 17, 2003
CONDUCTIVITY STANDARD SOLUTION-METERCARE
K032075 · FKH
Ibp Instruments GmbH
Gastroenterology & Urology · 72d
Cleared Sep 17, 2003
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K032137 · FGE
Cordis Corp.
Gastroenterology & Urology · 68d
Cleared Sep 17, 2003
R&D DESIGNATION AP-052-5
K032267 · EJT
Jensen Industries, Inc.
Dental · 56d
Cleared Sep 17, 2003
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K032269 · HRS
Synthes (Usa)
Orthopedic · 56d
Cleared Sep 17, 2003
THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM
K032495 · DZE
Lifecore Biomedical, Inc.
Dental · 35d
Cleared Sep 17, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE
K032567 · LON
Becton, Dickinson & CO
Microbiology · 28d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K032578 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Sep 17, 2003
UNITY NETWORK PATIENT DATA SERVER
K032582 · MSX
Ge Medical Systems Information...
Cardiovascular · 27d
Cleared Sep 17, 2003
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629
K032584 · GEI
Rubicor Medical, Inc.
General & Plastic Surgery · 27d
Cleared Sep 17, 2003
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
K032611 · GGN
Bio-Rad
Hematology · 23d