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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
43345–43368 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 2012
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3...
K122498 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 25d
Cleared Sep 10, 2012
HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX
K122612 · MAL
Maquet Cardiovascular, LLC
Cardiovascular · 14d
Cleared Sep 07, 2012
SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS
K113407 · GEI
Carefusion 2200, Inc.
General & Plastic Surgery · 294d
Cleared Sep 07, 2012
INFRARED THERMOMETER
K113761 · FLL
Famidoc Technology Co., Ltd.
General Hospital · 261d
Cleared CT Sep 07, 2012
TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
K113821 · DXG
Transonic Systems, Inc.
Cardiovascular · 255d
Cleared Sep 07, 2012
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
K120609 · LBS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 191d
Cleared Sep 07, 2012
ZYNO MEDICAL ADMINISTRATION SET
K120685 · FPA
Zyno Medical, LLC
General Hospital · 185d
Cleared Sep 07, 2012
B&W DENTAL IMPLANT SYSTEM
K120875 · DZE
B&W Srl
Dental · 169d
Cleared Sep 07, 2012
PONTO BONE ANCHORED HEARING SYSTEM
K121228 · MAH
Oticon Medical AB
Ear, Nose, Throat · 137d
Cleared Sep 07, 2012
MINI PATCH
K121353 · NUH
Well-Life Healthcare Limited
Neurology · 126d
Cleared Sep 07, 2012
HEMOCUE HBA1C 501
K121366 · LCP
Infopia Co, Ltd.
Chemistry · 123d
Cleared Sep 07, 2012
MINIARC PRO SINGLE-INCISION SLING SYSTEM
K121641 · PAH
American Medical Systems
Gastroenterology & Urology · 95d
Cleared Sep 07, 2012
SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS
K121714 · HSD
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Sep 07, 2012
VERACIA
K121749 · ELM
Shofu Dental Corporation
Dental · 85d
Cleared Sep 07, 2012
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K121797 · PSZ
Becton, Dickinson and Company
Microbiology · 80d
Cleared Sep 07, 2012
MASIMO SET USPO2 PULSE OXIMETRY CABLE
K121914 · DQA
Masimo Corporation
Anesthesiology · 67d
Cleared Sep 07, 2012
ARROW PICC POWERED BY ARROW VPS STYLET
K121941 · LJS
Arrow International (Subsidiary of...
General Hospital · 67d
Cleared Sep 07, 2012
DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER...
K121983 · IYN
Benq Medical Technology Corpation
Radiology · 63d
Cleared Sep 07, 2012
VITREAVIEW
K122136 · LLZ
Vital Images, Inc.
Radiology · 51d
Cleared Sep 07, 2012
MR VESSELLQ XPRESS
K122164 · LLZ
GE Medical Systems SCS
Radiology · 49d
Cleared Sep 07, 2012
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
K122301 · DTL
Vascular Solutions Zerusa , Ltd.
Cardiovascular · 37d
Cleared CT Sep 06, 2012
FOCUS TOUCH CONCEPTION SYSTEM
K112200 · OBB
Intimate Bridge 2 Conception, Inc.
Obstetrics & Gynecology · 402d
Cleared Sep 06, 2012
IMPELLA 2.5 PLUS CATHETER
K112892 · PBL
Abiomed, Inc.
Cardiovascular · 342d
Cleared Sep 06, 2012
LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF...
K113648 · HRS
Aap Implantate AG
Orthopedic · 269d