Search FDA 510(k) Devices

5,449 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2023–2023 ×
3,347 results
1393–1416 of 3,347
Cleared Aug 11, 2023
NOxBOXi Nitric Oxide Delivery System
K231823 · MRN
Linde Gas & Equipment, Inc.
Anesthesiology · 51d
Cleared Aug 11, 2023
Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
K231696 · KLE
Prevest Denpro Limited
Dental · 60d
Cleared Aug 11, 2023
NITINEX Memory Compression Staple
K231493 · JDR
Vilex, LLC
Orthopedic · 80d
Cleared Aug 11, 2023
Powder Free White, Black, and Purple Nitrile Examination Glove
K231439 · LZA
S&S Glove Corporation
General Hospital · 86d
Cleared Aug 11, 2023
Erchonia FX-405
K231409 · NHN
Erchonia Corporation
Physical Medicine · 88d
Cleared Aug 11, 2023
Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile
K231408 · LZA
Shandong Intco Medical Products Co, Ltd.
General Hospital · 88d
Cleared Aug 11, 2023
Electronic Blood Pressure Monitor
K230642 · DXN
Dongguan Kangweile Electronic...
Cardiovascular · 156d
Cleared Aug 11, 2023
VersiHD with GuideMe software
K230632 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 157d
Cleared Aug 11, 2023
Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core...
K230626 · MWI
Ge Medical Systems Information...
Anesthesiology · 157d
Cleared Aug 11, 2023
Dr. pen Microneedling System
K230420 · QAI
Guangzhou Ekai Electronic Technology...
General & Plastic Surgery · 176d
Cleared Aug 11, 2023
PolyWear® Personal Protective Level 3 Gown
K230384 · QPC
PolyConversions, Inc.
General Hospital · 178d
Cleared Aug 11, 2023
PMT Expandable Cage (PMT EXP)
K230297 · MRW
Providence Medical Technology, Inc.
Orthopedic · 190d
Cleared Aug 11, 2023
NuEra Tight RF Family
K223856 · GEI
Bios S.R.L.
General & Plastic Surgery · 231d
Cleared Aug 11, 2023
eRapid Nebulizer System
K223840 · CAF
Pari Respiratory Equipment, Inc.
Anesthesiology · 232d
Cleared Aug 11, 2023
Carex Hybrid Personal Lubricant
K223519 · NUC
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 261d
Cleared Aug 11, 2023
Otsuka Digital Feedback Device-RW
K223463 · OZW
Otsuka America Pharmaceutical, Inc.
Cardiovascular · 268d
Cleared Aug 11, 2023
BlueStar CGM insulin dose calculator
K222888 · QRX
Welldoc, Inc.
Chemistry · 322d
Cleared Aug 10, 2023
Aura 10 PET/CT
K231420 · QXL
Xeos Medical
Radiology · 86d
Cleared Aug 10, 2023
EnSite™ X EP System
K231415 · DQK
Abbott Medical
Cardiovascular · 86d
Cleared Aug 10, 2023
AirLife DuoTherm™ Humidification System
K231380 · BTT
Vyaire Medical, Inc.
Anesthesiology · 90d
Cleared Aug 10, 2023
ReliOn Premier BLU Blood Glucose Monitoring System
K230625 · NBW
I-Sens, Inc.
Chemistry · 157d
Cleared Aug 10, 2023
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
K230428 · EOQ
Ambu A/S
Ear, Nose, Throat · 174d
Cleared Aug 10, 2023
ZenPro 40
K230268 · GEX
BLUECORE COMPANY Co., Ltd.
General & Plastic Surgery · 191d
Cleared Aug 10, 2023
ANNE One
K223711 · DRG
Sibel Health, Inc.
Cardiovascular · 241d