Search FDA 510(k) Devices

5,400 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2021–2021 ×
3,023 results
865–888 of 3,023
Cleared Sep 24, 2021
Personal Lubricant
K210857 · NUC
Shenzhen Huanqiu Xuebao Technology...
Obstetrics & Gynecology · 185d
Cleared Sep 24, 2021
IV Administration Sets
K202618 · FPA
B.Braun Medical, Inc.
General Hospital · 379d
Cleared Sep 23, 2021
Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
K212792 · ODP
Medynus, Inc.
Orthopedic · 22d
Cleared Sep 23, 2021
Standard Bougie, 38 Fr. and Hand Pump
K212728 · KNT
Standard Bariatrics
Gastroenterology & Urology · 27d
Cleared Sep 23, 2021
Halo One Thin-Walled Guiding Sheath
K212708 · DYB
C.R. Bard, Inc.
Cardiovascular · 28d
Cleared Sep 23, 2021
Identity Imprint Knee Replacement System (including Identity Imprint...
K212411 · JWH
Conformis, Inc.
Orthopedic · 51d
Cleared Sep 23, 2021
ZIIP+ Device
K212342 · NFO
Ziip, Inc.
Neurology · 57d
Cleared Sep 23, 2021
JiveX (Model Number / Release: 5.3)
K212321 · LLZ
Visus Health IT GmbH
Radiology · 59d
Cleared Sep 23, 2021
Synthetic Vinyl Examination Gloves
K212002 · LYZ
Yunnan Huazhiyuan Medical Technology...
General Hospital · 87d
Cleared Sep 23, 2021
Nexta PEEK Hammertoe Correction System
K211996 · HWC
Nextremity Solutions, Inc.
Orthopedic · 87d
Cleared Sep 23, 2021
LED PHOTIC System
K211974 · GWE
Micromed S.P.A.
Neurology · 90d
Cleared Sep 23, 2021
Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)
K211827 · FXX
Zhejiang Lanhine Medical Products, Ltd.
General Hospital · 101d
Cleared Sep 23, 2021
Reusable NIBP Cuff
K211747 · DXQ
Shenzhen Coreray Technology Co., Ltd.
Cardiovascular · 108d
Cleared Sep 23, 2021
Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
K211667 · LAZ
Changzhou Universal Medical Equipment...
General & Plastic Surgery · 114d
Cleared Sep 23, 2021
OnGuard2 Chemfort Closed Administration (CADM)
K210707 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 197d
Cleared Sep 23, 2021
One Touch Spiral Condom
K210294 · HIS
Thai Nippon Rubber Industry Public...
Obstetrics & Gynecology · 233d
Cleared Sep 23, 2021
Sterile Hypodermic Needles for Single Use
K210232 · FMI
Zhejiang Kangkang Medical-Devices...
General Hospital · 238d
Cleared Sep 23, 2021
Automatic Digital Blood Pressure Monitor
K210152 · DXN
Aviche Shandong Medical Technology...
Cardiovascular · 245d
Cleared Sep 23, 2021
Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11
K203662 · FLL
Yibin Junxin Electronics Technology...
General Hospital · 282d
Cleared Sep 23, 2021
TorrentX Wound Wash
K203446 · FRO
Next Science, LLC
General & Plastic Surgery · 304d
Cleared Sep 23, 2021
ABC Dental Implant System
K202092 · DZE
Abracadabra Implants , Ltd.
Dental · 422d
Cleared Sep 22, 2021
FilmArray Pneumonia Panel
K212727 · QDP
Biofire Diagnostics, LLC
Microbiology · 26d
Cleared Sep 22, 2021
Single Use Guide Sheath Kit-401, K-402
K212667 · EOQ
Olympus Medical Systems Corp.
Anesthesiology · 30d
Cleared Sep 22, 2021
Smylio Invisible Clear Aligners
K212660 · NXC
Smylio, Inc.
Dental · 30d