FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
16321–16344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 31, 2021
Adhesive Electrode
K210448 · GXY
Shaoxing Yingtuo Healthcare Co., Ltd.
Neurology · 196d
Cleared Aug 31, 2021
Kubtec Mozart (XPERT42)
K210956 · MWP
Kub Technologies, Inc.
Radiology · 154d
Cleared Aug 31, 2021
Kubec Xpert 80 Radiography System
K210957 · MWP
Kub Technologies, Inc.
Radiology · 154d
Cleared Aug 31, 2021
Triton™ Sacroiliac Joint Fixation System
K211449 · OUR
Choice Spine, LLC
Orthopedic · 113d
Cleared Aug 31, 2021
CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini...
K211704 · ODP
Orthofix, Inc.
Orthopedic · 89d
Cleared Aug 31, 2021
Tactoset Injectable Bone Substitute
K212083 · MQV
Anika Therapeutics, Inc.
Orthopedic · 60d
Cleared Aug 31, 2021
DR 800 with DSA, DR 800
K212145 · JAA
Agfa N.V.
Radiology · 53d
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