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
69961–69984 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2004
PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50
K040304 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 21d
Cleared Mar 01, 2004
ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS...
K040338 · GEI
Arthrocare Corp.
General & Plastic Surgery · 19d
Cleared Mar 01, 2004
KOMPRESSOR SCREW SYSTEM
K040356 · HWC
Kinetikos Medical, Inc.
Orthopedic · 17d
Cleared Mar 01, 2004
LIGHTSPEED 7.0 CT SCANNER SYSTEM
K040372 · JAK
Ge Medical Systems, LLC
Radiology · 13d
Cleared Feb 27, 2004
EXACTECH RESORBABLE BONE PASTE
K020078 · MQV
Exactech, Inc.
Orthopedic · 779d
Cleared Feb 27, 2004
AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE
K032421 · MKJ
Ambu, Inc.
Cardiovascular · 206d
Cleared Feb 27, 2004
NEXIVA CLOSED IV CATHETER SYSTEM
K032843 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 169d
Cleared Feb 27, 2004
RANDOX URIC ACID
K033278 · CDO
Randox Laboratories, Ltd.
Chemistry · 140d
Cleared Feb 27, 2004
CONDUCTIVITY/TDS CALIBRATOR SOLUTION
K033330 · FKH
Mesa Laboratories, Inc.
Gastroenterology & Urology · 134d
Cleared Feb 27, 2004
POWER LED
K033697 · EBZ
Dental Products of USA, Inc.
Dental · 94d
Cleared Feb 27, 2004
TRANSVAGINAL ENDOSCOPY SET
K033728 · HEW
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 91d
Cleared Feb 27, 2004
BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR
K033771 · MKJ
Bio-Detek, Inc.
Cardiovascular · 86d
Cleared Feb 27, 2004
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND...
K033786 · JIT
Ibl GmbH
Chemistry · 85d
Cleared Feb 27, 2004
ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
K033802 · DHR
Zeus Scientific, Inc.
Immunology · 81d
Cleared Feb 27, 2004
VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126
K033879 · DKB
Maine Standards Co.
Toxicology · 74d
Cleared Feb 27, 2004
KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM
K034027 · MQN
KLS-Martin L.P.
Dental · 60d
Cleared Feb 27, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE
K040006 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Feb 27, 2004
CENTRAL STATION, VERSION 3.3H
K040032 · DXN
Hommed, LLC
Cardiovascular · 50d
Cleared Feb 27, 2004
TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING
K040129 · GCA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 37d
Cleared Feb 27, 2004
ON-BOARD IMAGER DEVICE
K040192 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Feb 27, 2004
EP-4 CLINICAL STIMULATOR
K040207 · JOQ
Ep Medsystems
Cardiovascular · 28d
Cleared Feb 27, 2004
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
K040211 · KGN
Collagen Matrix, Inc.
General & Plastic Surgery · 28d
Cleared Feb 27, 2004
LYPHOCHEK HEMOSTASIS CONTROL
K040275 · GGN
Bio-Rad
Hematology · 22d
Cleared Feb 27, 2004
LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM
K040409 · IYN
Larsen & Toubro Limited
Radiology · 9d