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
66937–66960 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 2005
PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)
K043206 · MQP
Pioneer Surgical Technology
Orthopedic · 63d
Cleared Jan 21, 2005
R2-MRI ANALYSIS SYSTEM
K043271 · LNH
Inner Vision Biometrics Pty, Ltd.
Radiology · 56d
Cleared Jan 21, 2005
OPTISTRAND, MODEL 1032S
K043336 · KXK
Ibt SA
Radiology · 49d
Cleared Jan 21, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN)...
K043389 · LON
Becton, Dickinson & CO
Microbiology · 43d
Cleared Jan 21, 2005
CENTRICITY PACS SYSTEM
K043415 · LLZ
Ge Medical Systems Information...
Radiology · 39d
Cleared Jan 21, 2005
ALLOGRAN-N-BONE VOID FILLER
K043514 · MQV
Biocomposites, Ltd.
Orthopedic · 32d
Cleared Jan 21, 2005
MODIFICATION TO OUTBACK CATHETER
K043534 · DQY
Lumend, Inc.
Cardiovascular · 30d
Cleared Jan 21, 2005
INFINITY GATEWAY SUITE, VF4
K043549 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 29d
Cleared Jan 21, 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359
K043560 · HRS
Zimmer, Inc.
Orthopedic · 25d
Cleared Jan 21, 2005
OCEAN CHEST DRAIN
K043582 · KDQ
Atrium Medical Corp.
General Hospital · 24d
Cleared Jan 19, 2005
VISTA PLUS
K042108 · MLO
Novacor
Cardiovascular · 168d
Cleared Jan 19, 2005
MASIMO SET RAD 57 PULSE CO-OXIMETER
K042536 · DQA
Masimo Corporation
Anesthesiology · 121d
Cleared Jan 19, 2005
MODIFICATION TO: RADIANALYZER, MODEL 12711
K042628 · DQK
Radi Medical Systems AB
Cardiovascular · 114d
Cleared Jan 19, 2005
LIFESCREEN APNEA
K042745 · MNR
Del Mar Reynolds Medical, Inc.
Anesthesiology · 107d
Cleared Jan 19, 2005
SPY INTRA-OPERATIVE IMAGING SYSTEM: SP2000
K042961 · IZI
Novadaq Technologies, Inc.
Radiology · 84d
Cleared Jan 19, 2005
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
K043060 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 75d
Cleared Jan 19, 2005
PINN-ACL CROSSPIN
K043106 · HTY
Linvatec Corp.
Orthopedic · 71d
Cleared Jan 19, 2005
FLOWCARE PLG CD4 REAGENT
K043215 · GKZ
Beckman Coulter, Inc.
Hematology · 61d
Cleared Jan 19, 2005
CHARLOTTE HIGH-DEMAND COMPRESSION SCREW
K043281 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 54d
Cleared Jan 19, 2005
TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840
K043382 · BZD
Tiara Medical Systems, Inc.
Anesthesiology · 41d
Cleared Jan 19, 2005
DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES...
K043508 · KGO
Ansell Healthcare Products, LLC
General Hospital · 30d
Cleared Jan 18, 2005
SOUNDSKIN PHOTOTHERAPY SYSTEM
K040103 · GEX
Bhc International, Ltd.
General & Plastic Surgery · 364d
Cleared Jan 18, 2005
ATAD ARD CATHETER
K040625 · HDY
Atad Developments , Ltd.
Obstetrics & Gynecology · 315d
Cleared Jan 18, 2005
DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
K042709 · EZL
Tyco Healthcare
Gastroenterology & Urology · 110d