Search FDA 510(k) Database

6,792 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
13849–13872 of 174,061
Cleared Nov 23, 2021
Albumin BCG2
K203248 · CIX
Abbott Ireland Diagnostics Division
Chemistry · 384d
Cleared Nov 23, 2021
Playboy Premium Silicone Lubricant
K210095 · NUC
Thai Nippon Rubber Industry Public...
Obstetrics & Gynecology · 313d
Cleared Nov 23, 2021
Sofia 2 Campylobacter FIA
K211342 · LQP
Quidel Corporation
Microbiology · 204d
Cleared Nov 23, 2021
Uretero1 Ureteroscope System
K211347 · FGB
STERIS Corporation
Gastroenterology & Urology · 204d
Cleared Nov 23, 2021
Breathe Easy Mobile Respiratory Monitor (MRM)
K211387 · BZQ
Sound Life Sciences, Inc.
Anesthesiology · 202d
Cleared Nov 23, 2021
Myomics Q
K211432 · LLZ
Phantomics, Inc.
Radiology · 200d
Cleared Nov 23, 2021
Virtue RF
K211562 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 187d
Cleared Nov 23, 2021
PCEA Syringe Set
K211649 · PWH
Baxter Healthcare Corporation
General Hospital · 179d
Cleared Nov 23, 2021
Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub...
K211765 · FYA
Cardinal Health, LLC
General Hospital · 168d
Cleared Nov 23, 2021
039 Surgical Face Mask
K211956 · FXX
Aok Tooling Limited
General Hospital · 152d
Cleared Nov 23, 2021
da Vinci SP Firefly Imaging System
K212101 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 140d
Cleared Nov 23, 2021
Exablate Prostate System
K212150 · PLP
InSightec, Inc.
Gastroenterology & Urology · 137d
Cleared Nov 23, 2021
Air compression therapy system FO3002
K212169 · IRP
Foshan Hongfeng Co., Ltd.
Physical Medicine · 134d
Cleared Nov 23, 2021
Hypotension Decision Assist Model HDA-OR2
K212529 · DXG
Directed Systems, Ltd.
Cardiovascular · 104d
Cleared Nov 23, 2021
MZ Skin LightMAX Supercharged LED Mask 2.0
K213184 · OLP
Mz Skin
General & Plastic Surgery · 55d
Cleared Nov 23, 2021
Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm,...
K213454 · HBE
Medtronic Powered Surgical Solutions
Neurology · 28d
Cleared Nov 22, 2021
VS3 Iridium Sytem
K210265 · OWN
Visionsense, Ltd.
General & Plastic Surgery · 294d
Cleared Nov 22, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K210943 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 237d
Cleared Nov 22, 2021
Non-sterile Powder Free Nitrile Examination Gloves
K210990 · LZA
Rubberex Alliance Sdn Bhd
General Hospital · 234d
Cleared Nov 22, 2021
Philips Incisive CT on Trailer
K211168 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 217d
Cleared Nov 22, 2021
Eclipse PRO
K211651 · MWJ
Spacelabs Healthcare, Ltd.
Cardiovascular · 178d
Cleared Nov 22, 2021
Pre-Formed Extra Support Guidewire
K211741 · DQX
Lake Region Medical
Cardiovascular · 168d
Cleared Nov 22, 2021
VITA Akzent LC
K211854 · EBD
Vita Zahnfabrik GmbH H Rauter & CO
Dental · 159d
Cleared Nov 22, 2021
Agile Esophageal OTW Stent System
K211960 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 151d