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

Filters: Cleared only ×
176,076 results
80017–80040 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 07, 2001
ATLAST DATA MANAGEMENT SOFTWARE (DMS)
K010605 · CGA
Amira Medical, Inc.
Chemistry · 68d
Cleared May 07, 2001
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
K010666 · QPB
Medtronic Xomed, Inc.
General & Plastic Surgery · 62d
Cleared May 07, 2001
XPS 3000 SYSTEM
K010677 · HRX
Medtronic Xomed, Inc.
Orthopedic · 61d
Cleared May 07, 2001
SIMPLICT
K010813 · JAK
Neorad AS
Radiology · 49d
Cleared May 04, 2001
TETRAD TC-C3-ACP
K002193 · ITX
Tetrad Corp.
Radiology · 288d
Cleared May 04, 2001
REMREST
K002763 · BZD
Medical Industries America, Inc.
Anesthesiology · 241d
Cleared May 04, 2001
MPS M ELECTRODE
K002801 · LNS
Medical Physics and Services, Inc.
Gastroenterology & Urology · 238d
Cleared May 04, 2001
RENAX A.V. FISTULA NEEDLE SETS
K003123 · FIE
Sunder Biomedical Tech. Co., Ltd.
Gastroenterology & Urology · 211d
Cleared May 04, 2001
MODIFICATION TO EDI VERIS SYSTEM
K003442 · HLX
Electro-Diagnostic Imaging, Inc.
Ophthalmic · 179d
Cleared May 04, 2001
DEVILBISS HUMIDIFIER
K003626 · BTT
Sunrise Medical Hhg, Inc.
Anesthesiology · 161d
Cleared May 04, 2001
MICROGAS 7650 TRANSCUTANEOUS MONITOR
K003943 · KLK
Linde Medical Sensors AG
Anesthesiology · 134d
Cleared May 04, 2001
IVD (IN VIVO DOSIMETER), MODEL 1131
K010449 · IYE
Sun Nuclear Corp.
Radiology · 78d
Cleared May 04, 2001
MICROSTREAM ORAL NASAL CANNULA FILTERLINE
K011050 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 28d
Cleared May 04, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011067 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared May 04, 2001
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER...
K011098 · MXC
Medtronic Vascular
Cardiovascular · 23d
Cleared May 04, 2001
APEX FIXATION PINS
K011136 · JDW
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared May 04, 2001
WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
K011178 · LQC
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 17d
Cleared May 04, 2001
HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES...
K011224 · IYN
Advanced Technology Laboratories, Inc.
Radiology · 14d
Cleared May 03, 2001
TISSUE MARKER
K001807 · GDW
Advanced Uroscience, Inc.
General & Plastic Surgery · 322d
Cleared May 03, 2001
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
K002256 · DSP
Arrow Intl., Inc.
Cardiovascular · 282d
Cleared May 03, 2001
BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230...
K002565 · GXD
Baylis Medical Co., Inc.
Neurology · 259d
Cleared May 03, 2001
SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
K003458 · HGP
Clinical Innovations, Inc.
Obstetrics & Gynecology · 177d
Cleared May 03, 2001
SANARUS CORE TISSUE BIOPSY SYSTEM
K003528 · KNW
Endocare, Inc.
Gastroenterology & Urology · 168d
Cleared May 03, 2001
ADJUSTABLE LARGE FIXATOR SYSTEM
K010344 · KTT
Synthes (Usa)
Orthopedic · 87d