Search FDA 510(k) Database

6,818 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
14569–14592 of 174,061
Cleared Aug 31, 2021
EndoNaut
K212383 · OWB
Therenva Sas
Radiology · 29d
Cleared Aug 30, 2021
Impulse AM Interbody Fusion System
K210090 · MAX
Degen Medical
Orthopedic · 229d
Cleared Aug 30, 2021
Ceribell Instant EEG Headband
K210805 · GXY
Ceribell, Inc.
Neurology · 166d
Cleared Aug 30, 2021
Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor,...
K211041 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 144d
Cleared Aug 30, 2021
Paratrooper Plantar Plate Repair System
K211322 · MBI
Paragon 28, Inc.
Orthopedic · 122d
Cleared Aug 30, 2021
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
K211630 · LON
bioMerieux, Inc.
Microbiology · 95d
Cleared Aug 30, 2021
Shoreline Threaded TruProfile® Plate
K211903 · KWQ
SeaSpine Orthopedics Corporation
Orthopedic · 70d
Cleared Aug 30, 2021
Senhance Surgical System
K212054 · NAY
Asensus Surgical, Inc.
General & Plastic Surgery · 61d
Cleared Aug 30, 2021
KMTI S141 Lumbar Interbody Fusion System
K212070 · MAX
Kyocera Medical Technologies, Inc.
Orthopedic · 59d
Cleared Aug 30, 2021
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2
K212103 · MUH
Fona S.R.L
Radiology · 55d
Cleared Aug 28, 2021
AnyOne External Implant System
K203554 · DZE
Megagen Implant Co., Ltd.
Dental · 267d
Cleared Aug 28, 2021
Surgical Mask
K211255 · FXX
Tianchang Kanghui Protective Products...
General Hospital · 124d
Cleared Aug 28, 2021
Nitrile Blue Powder-free Examination Glove
K211390 · LZA
Cardinal Health200, LLC
General Hospital · 115d
Cleared Aug 27, 2021
Surgical mask
K202746 · FXX
Ningbo Jingeao Electronics, Inc.
General Hospital · 343d
Cleared Aug 27, 2021
AXS Vecta 46 Intermediate Catheter
K202752 · QJP
Stryker Neurovascular
Neurology · 340d
Cleared Aug 27, 2021
Neuspera Neurostimulation System (NNS)
K202781 · GZF
Neuspera Medical, Inc.
Neurology · 339d
Cleared Aug 27, 2021
Needle Stimulator
K202861 · BWK
Wuxi Jiajian Medical Instrument Co.,...
Neurology · 333d
Cleared Aug 27, 2021
SOLOPASS System
K203251 · HAW
Intravent Medical Partners, LP
Neurology · 296d
Cleared Aug 27, 2021
ENFit Reusable Enteral Syringe
K203613 · PNR
Shantou Wealy Medical Instrument Co.,Ltd
Gastroenterology & Urology · 260d
Cleared Aug 27, 2021
RBknee
K203696 · LLZ
Radiobotics Aps
Radiology · 252d
Cleared Aug 27, 2021
Stiletto Extended Dwell Catheter
K210047 · PND
Piper Access, LLC
General Hospital · 231d
Cleared Aug 27, 2021
Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
K210122 · MAI
Osteonic Co., Ltd.
Orthopedic · 220d
Cleared Aug 27, 2021
Clear Aligners
K210373 · NXC
Shenzhen Yinuo Dental Technology Co.Ltd
Dental · 200d
Cleared Aug 27, 2021
Trevo NXT ProVue Retriever
K210502 · POL
Stryker Neurovascular
Neurology · 186d