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

Filters: Cleared only ×
175,820 results
52129–52152 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 2009
FLEXICARE BREATHING FILTERS
K092218 · CAH
Flexicare Medical, Ltd.
General Hospital · 76d
Cleared Oct 06, 2009
NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
K092287 · NKB
Nuvasive, Inc.
Orthopedic · 69d
Cleared Oct 05, 2009
ADDPLUS
K090841 · MQP
Ulrich GmbH & Co. KG
Orthopedic · 192d
Cleared Oct 02, 2009
MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN
K090568 · LZA
Medline Industries, Inc.
General Hospital · 213d
Cleared Oct 02, 2009
EOCENE SYSTEM
K090712 · NBW
Infopia Co, Ltd.
Chemistry · 198d
Cleared Oct 02, 2009
KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE
K090919 · NPL
Kensey Nash Corp.
Dental · 184d
Cleared Oct 02, 2009
DBX DEMINERALIZED BONE MATRIX PUTTY
K091217 · NUN
Musculoskeletal Transplant Foundation
Dental · 158d
Cleared Oct 02, 2009
AIA-PACK RBC FOLATE
K091332 · CGN
Tosoh Bioscience, Inc.
Chemistry · 149d
Cleared Oct 02, 2009
MICROFUSE DUAL RATE INFUSER
K091386 · FRN
Numia Medical Technology, LLC
General Hospital · 144d
Cleared Oct 02, 2009
LEFORTE SYSTEM BONE PLATE
K091679 · JEY
Jeil Medical Corporation
Dental · 115d
Cleared Oct 02, 2009
CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23
K091721 · GEH
New Medical Technologies GmbH
General & Plastic Surgery · 113d
Cleared Oct 02, 2009
SUPER-FINE PEN NEEDLE
K092016 · FMI
Stat Medical Devices, Inc.
General Hospital · 88d
Cleared Oct 02, 2009
EASYCARE TX, TX LINK
K092026 · BZD
Resmed, Ltd.
Anesthesiology · 88d
Cleared Oct 02, 2009
LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM
K092037 · DRT
Hoana Medical, Inc.
Cardiovascular · 88d
Cleared Oct 02, 2009
STELLAR FIDUCIAL MARKER, MODEL GFMIA
K092041 · IYE
Stellar Medical, LLC
Radiology · 87d
Cleared Oct 02, 2009
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
K092058 · IYN
Sonosite,Inc.
Radiology · 86d
Cleared Oct 02, 2009
SYNERGY CANNULATED SCREW SYSTEM
K092082 · HWC
Synergy Surgical Technologies, LLC
Orthopedic · 85d
Cleared Oct 02, 2009
ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC...
K092111 · EWO
Entomed AB
Ear, Nose, Throat · 80d
Cleared Oct 02, 2009
MODEL SENTINELLA 102
K092471 · IYX
General Equipment For Medical...
Radiology · 52d
Cleared Oct 02, 2009
TSRH SPINAL SYSTEM
K092676 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 31d
Cleared Oct 02, 2009
BAXANO NEURO CHECK DEVICE
K092729 · ETN
Baxano, Inc.
Ear, Nose, Throat · 28d
Cleared Oct 01, 2009
WATERLASE MD
K083927 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 274d
Cleared Oct 01, 2009
CARTO RMT EP NAVIGATION SYSTEM V8
K091789 · DQK
Biosense Webster, Inc.
Cardiovascular · 106d
Cleared Oct 01, 2009
PICCOLO MAGNESIUM TEST SYSTEM
K091910 · JGJ
Abaxis, Inc.
Chemistry · 98d