Search FDA 510(k) Database

7,052 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
19777–19800 of 174,061
Cleared Nov 18, 2019
CLEARFIL MAJESTY ES Flow
K191980 · EBF
Kuraray Noritake Dental, Inc.
Dental · 117d
Cleared Nov 18, 2019
PolyLock Small Bone Plating System
K192323 · HRS
Fusion Orthopedics, LLC
Orthopedic · 83d
Cleared Nov 18, 2019
Impella CP Introducer
K192769 · DYB
Abiomed, Inc.
Cardiovascular · 49d
Cleared Nov 16, 2019
3M Comply Hydrogen Peroxide Chemical Indicator
K192937 · JOJ
3M Company
General Hospital · 29d
Cleared Nov 15, 2019
ROSA Bracket
K182672 · NJM
Gni Co., Ltd.
Dental · 415d
Cleared Nov 15, 2019
KeyPrint KeySplint Soft
K183598 · MQC
Keystone Industries
Dental · 324d
Cleared Nov 15, 2019
Dornier Ureteral Stent
K190312 · FAD
Dornier Medtech America, Inc.
Gastroenterology & Urology · 276d
Cleared Nov 15, 2019
TDM Plate and Screw Systems
K190391 · HRS
Tdm Co., Ltd.
Orthopedic · 269d
Cleared Nov 15, 2019
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
K190397 · QBK
Immunalysis Corporation
Toxicology · 269d
Cleared Nov 15, 2019
EM SA Implant System
K191201 · DZE
Hiossen, Inc.
Dental · 193d
Cleared Nov 15, 2019
SmartSPACE Shoulder System
K191247 · KWS
Techmah Medical, LLC
Orthopedic · 190d
Cleared Nov 15, 2019
Arcus Head Fixation Frame
K191701 · HBL
Mri Interventions, Inc.
Neurology · 143d
Cleared Nov 15, 2019
Gabriel Feeding Tube with Balloon, and EnFit Connector
K191784 · PIF
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 135d
Cleared Nov 15, 2019
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting...
K191921 · PFO
Cochlear Americas
Ear, Nose, Throat · 120d
Cleared Nov 15, 2019
Ophthalmic Yag Laser System YC-200
K192045 · HQF
Nidek Co., Ltd.
Ophthalmic · 107d
Cleared Nov 15, 2019
DRSplus
K192113 · MYC
Centervue S.P.A.
Ophthalmic · 102d
Cleared Nov 15, 2019
SPY Portable Handheld Imaging (SPY-PHI) System
K192174 · OWN
Novadaq Technologies Ulc. (Now A Part...
General & Plastic Surgery · 95d
Cleared Nov 15, 2019
Pentax Medical Video Duodenoscope ED34-i10T2
K192245 · FDT
Pentax of America, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 15, 2019
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K192289 · JXG
Irras USA, Ltd.
Neurology · 84d
Cleared Nov 15, 2019
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
K192842 · GGM
Eurotrol B.V.
Hematology · 43d
Cleared Nov 15, 2019
CAPERE Thrombectomy System
K192935 · QEW
Vascular Medcure, Inc.
Cardiovascular · 29d
Cleared Nov 15, 2019
Soltus 500
K192936 · IZL
Sedecal., Sa.
Radiology · 28d
Cleared Nov 15, 2019
CoolTone
K192940 · NGX
Zimmer Medizinsysteme GmbH
Physical Medicine · 28d
Cleared Nov 14, 2019
EBA One Nailing System
K183666 · HSB
Citieffe S.R.L.
Orthopedic · 322d