Search FDA 510(k) Database

6,693 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
12121–12144 of 174,061
Cleared Jun 10, 2022
Elecsys AMH
K203757 · PQO
Roche Diagnostics
Chemistry · 534d
Cleared Jun 10, 2022
EasyClip® and EasyClip® Xpress
K210582 · JDR
Stryker GmbH
Orthopedic · 469d
Cleared Jun 10, 2022
PAL System
K212024 · QPB
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 346d
Cleared Jun 10, 2022
Armory Motion
K213097 · ILO
Pain Management Technologies, Inc.
Neurology · 259d
Cleared Jun 10, 2022
Extroducer Infusion Catheter System
K213442 · KRA
SmartWise Sweden AB
Cardiovascular · 228d
Cleared Jun 10, 2022
WesperO2
K213515 · DQA
Wesper, Inc.
Anesthesiology · 220d
Cleared Jun 10, 2022
Rune Labs Tremor Transducer System
K213519 · GYD
Rune Labs, Inc.
Neurology · 219d
Cleared Jun 10, 2022
iFuse-TORQ® Implant System
K213667 · OUR
SI-BONE, Inc.
Orthopedic · 200d
Cleared Jun 10, 2022
Pre-filled Syringe with Saline
K220060 · NGT
Jiangsu Caina Medical Co.,Ltd
General Hospital · 151d
Cleared Jun 10, 2022
Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System
K220319 · HWC
Stryker GmbH
Orthopedic · 127d
Cleared Jun 10, 2022
Saffron Fixation System
K220420 · PBQ
Coloplast A/S
Obstetrics & Gynecology · 116d
Cleared Jun 10, 2022
Surgical Isolation Cover Gown
K220528 · FYC
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 106d
Cleared Jun 10, 2022
IntellaMap Orion High Resolution Mapping Catheter
K220796 · DRF
Boston Scientific Corporation
Cardiovascular · 84d
Cleared Jun 10, 2022
SmileGuard
K220894 · MQC
Envisiontec GmbH
Dental · 74d
Cleared Jun 10, 2022
MediLab
K221065 · LLZ
Sigma Scientific Services, LLC
Radiology · 59d
Cleared Jun 10, 2022
Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
K221087 · HAW
Medtronic Navigation, Inc.
Neurology · 58d
Cleared Jun 10, 2022
Omni Foot and Ankle Plating System
K221362 · HRS
Exremity Medical, LLC
Orthopedic · 30d
Cleared Jun 10, 2022
Nalu Neurostimulation System
K221376 · GZB
Boston Scientific Neuromodulation
Neurology · 29d
Cleared Jun 10, 2022
Swoop Portable MR Imaging System
K221393 · LNH
Hyperfine, Inc.
Radiology · 28d
Cleared Jun 10, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221658 · PBK
Centers For Disease Control and...
Microbiology · 2d
Cleared Jun 09, 2022
ACUTRON
K211000 · GEI
Ilooda Co,., Ltd.
General & Plastic Surgery · 433d
Cleared Jun 09, 2022
Cysto-Gastro-Sets
K211909 · KNS
G-Flex Europe Sprl
Gastroenterology & Urology · 353d
Cleared Jun 09, 2022
KHEIRON® Spinal Fixation System
K211981 · NKB
S.M.A.I.O
Orthopedic · 349d
Cleared Jun 09, 2022
HELIOS IV 785
K212663 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 290d