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
75385–75408 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 2002
TRANSONIC FLOW-QC SET MODEL ADT1010
K021571 · MQS
Transonic Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 12, 2002
TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
K021574 · HGM
Card Guard Scientific Survival , Ltd.
Obstetrics & Gynecology · 90d
Cleared Aug 12, 2002
PATXFER
K021583 · LLZ
Brainlab AG
Radiology · 90d
Cleared Aug 12, 2002
HALLU PLATES
K021626 · HRS
New Deal, S.A.
Orthopedic · 87d
Cleared Aug 12, 2002
UKNEE TOTAL KNEE SYSTEM
K021657 · JWH
United Orthopedic Corp.
Orthopedic · 84d
Cleared Aug 12, 2002
PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR...
K021659 · LYY
P.T. Healthcare Glovindo
General Hospital · 84d
Cleared Aug 12, 2002
MAGLY 6.5MM CANNULATED SCREWS
K021662 · HWC
Magly Orthopedics, LLC
Orthopedic · 84d
Cleared Aug 12, 2002
NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR)
K021668 · LZA
Innovative Gloves Co;, Ltd.
General Hospital · 83d
Cleared Aug 12, 2002
MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR
K021720 · LPL
Soflex Isralens Contact Lens , Ltd.
Ophthalmic · 80d
Cleared Aug 12, 2002
EBI DYNAFIX VS OSTEOTOMY SYSTEM
K021749 · NDF
Ebi, L.P.
Orthopedic · 76d
Cleared Aug 12, 2002
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET...
K021902 · JQC
Medtronic Vascular
Hematology · 63d
Cleared Aug 12, 2002
MODIFICATION TO MEDSTATION
K021934 · LLZ
Aisoftw@Re Medical, S.P.A.
Radiology · 61d
Cleared Aug 12, 2002
FULCRUM
K021949 · LMA
Howtek, Inc.
Radiology · 60d
Cleared Aug 12, 2002
ALPHA INFUSION PUMP AND CATHETERS
K021964 · MEB
Advanced Infusion, Inc.
General Hospital · 59d
Cleared Aug 12, 2002
SYDNEY IVF CULTURE OIL
K022002 · MQL
Cook Urological, Inc.
Obstetrics & Gynecology · 54d
Cleared Aug 12, 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K022172 · LON
Becton, Dickinson & CO
Microbiology · 40d
Cleared Aug 12, 2002
CADENCE CEMENT RESTRICTOR
K022218 · JDK
Spinal Concepts, Inc.
Orthopedic · 34d
Cleared Aug 12, 2002
HYDROBOOT
K022233 · DWL
Incappe, Inc.
General Hospital · 33d
Cleared Aug 12, 2002
EBI XFIX DFS SYSTEM
K022319 · KTT
Ebi, L.P.
Orthopedic · 26d
Cleared Aug 12, 2002
MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE
K022405 · GZJ
Rehabilicare, Inc.
Neurology · 27d
Cleared Aug 12, 2002
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K022419 · KWQ
Ebi, L.P.
Orthopedic · 19d
Cleared Aug 12, 2002
RAPID-FILL TUBESET, MODEL 90005
K022523 · LHI
Baxa Corp.
General Hospital · 13d
Cleared Aug 12, 2002
HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
K022546 · EOQ
Horizons Intl. Corp.
Ear, Nose, Throat · 11d
Cleared Aug 09, 2002
FLEXLINE CLAMP
K010727 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 515d