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
58321–58344 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 2007
BIS MODULE FOR ENVOY PATIENT MONITOR
K071899 · OLW
Mennen Medical , Ltd.
Neurology · 105d
Cleared Oct 22, 2007
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
K071931 · HBF
Codman & Shurtleff, Inc.
Neurology · 101d
Cleared Oct 22, 2007
ONCONTROL BONE MARROW BIOPSY SYSTEM
K072045 · KNW
Vidacare Corporation
Gastroenterology & Urology · 89d
Cleared Oct 19, 2007
AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER
K062932 · JKA
Ahlstrom Mount Holly Springs, LLC
Chemistry · 386d
Cleared Oct 19, 2007
ORAL NEUTRALIZER
K071617 · LFD
Oral Biotech
Dental · 128d
Cleared Oct 19, 2007
CAPSEW PLICATION SYSTEM
K071796 · GAT
Cayenne Medical, Inc.
General & Plastic Surgery · 109d
Cleared Oct 19, 2007
NEOSS VARIOUS TITANIUM ABUTMENTS
K071838 · NHA
Neoss, Ltd.
Dental · 106d
Cleared Oct 19, 2007
BONALIVE GRANULES AND BONALIVE PLATES
K071937 · KKY
Vivoxid , Ltd.
General & Plastic Surgery · 98d
Cleared Oct 19, 2007
LTM-RC SURGICAL MESH
K071986 · FTM
Lifecell Corp.
General & Plastic Surgery · 91d
Cleared Oct 19, 2007
CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE
K072016 · GXY
Technomed Europe
Neurology · 88d
Cleared Oct 19, 2007
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
K072235 · DQA
Shenzhen Mindray Bio-Medical...
Anesthesiology · 70d
Cleared Oct 19, 2007
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
K072339 · KWQ
Nuvasive, Inc.
Orthopedic · 60d
Cleared Oct 19, 2007
FLEX-STAR V
K072402 · EBI
Cmp Industries, LLC
Dental · 53d
Cleared Oct 19, 2007
ATLAS SPINE PEDICLE SCREW SYSTEM
K072426 · NKB
Atlas Spine, LLC
Orthopedic · 51d
Cleared Oct 19, 2007
LANFAN POWDER-FREE VINYL EXAM GLOVES
K072488 · LYZ
Shanghai Lanfan Co., Ltd.
General Hospital · 45d
Cleared Oct 19, 2007
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
K072638 · JGQ
Roche Diagnostics Corp.
Chemistry · 31d
Cleared Oct 19, 2007
NGARDE SYSTEM
K072685 · NQP
N-Spine, Inc.
Orthopedic · 28d
Cleared Oct 19, 2007
DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES
K072789 · GEI
Encision, Inc.
General & Plastic Surgery · 18d
Cleared Oct 18, 2007
MODIFICATION TO PASSMED SPINAL SYSTEM
K070530 · MNH
Medicrea Technologies
Orthopedic · 237d
Cleared Oct 18, 2007
REPROCESSED AUTOSUTURE GIA ENDOSCOPIC STAPLERS
K070930 · NLL
Sterilmed, Inc.
General & Plastic Surgery · 198d
Cleared Oct 18, 2007
REDSENSE
K071013 · ODX
Redsense Medical AB
Gastroenterology & Urology · 191d
Cleared Oct 18, 2007
TRU RSV
K071101 · GOG
Meridian Bioscience, Inc.
Microbiology · 182d
Cleared Oct 18, 2007
RAPHAEL COLOR ASV VENTILATOR
K071194 · CBK
Hamilton Medical AG
Anesthesiology · 171d
Cleared Oct 18, 2007
PERFECT TISSUE CONTOURING SYSTEM II
K071632 · EKZ
Coltene/Whaledent, Inc.
Dental · 126d