Search FDA 510(k) Database

6,451 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
8353–8376 of 174,061
Cleared Aug 16, 2023
Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
K230577 · FYA
Medcare Saglik Urunleri Sanayi VE...
General Hospital · 168d
Cleared Aug 16, 2023
Phototherapy System (OL-PDT950)
K230342 · GEX
Shanghai Omni Laser Skinology Co., Ltd.
General & Plastic Surgery · 189d
Cleared Aug 16, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
K230314 · LZA
New Era Medicare Sdn. Bhd.
General Hospital · 191d
Cleared Aug 16, 2023
Celsi Monitor
K230298 · FLL
Hadleigh Health Technologies
General Hospital · 195d
Cleared Aug 16, 2023
SOMNUM (V.1.1.2.)
K223922 · OLZ
Honeynaps Co., Ltd.
Neurology · 229d
Cleared Aug 16, 2023
Kyphoplasty Balloon Catheter
K223709 · HRX
Jiangsu Changmei Medtech Co., Ltd.
Orthopedic · 247d
Cleared Aug 16, 2023
AQUAbase nX
K223479 · FIP
B.Braun Medical, Inc.
Gastroenterology & Urology · 271d
Cleared Aug 16, 2023
HemoScreen Hematology Analyzer
K222148 · GKZ
Pixcell Medical Technologies, Ltd.
Hematology · 392d
Cleared Aug 15, 2023
21HQ513D, 32HL512D, 31HN713D, 32HQ713D
K232127 · PGY
Lg Electronics.Inc
Radiology · 29d
Cleared Aug 15, 2023
RxSight® Insertion Device (63002)
K231838 · MSS
Rxsight, Inc.
Ophthalmic · 54d
Cleared Aug 15, 2023
Xenix Medical Sacroiliac Fixation System
K231829 · OUR
Ht Medical D.B.A. Xenix Medical
Orthopedic · 55d
Cleared Aug 15, 2023
primaLOK™ SP Interspinous Fusion System
K231807 · PEK
Wenzel Spine, Inc.
Orthopedic · 56d
Cleared Aug 15, 2023
MA012 Aluminum wheelchair, MS019 steel wheelchair
K231750 · IOR
Sichuan Ast Medical Equipment Co., Ltd.
Physical Medicine · 61d
Cleared Aug 15, 2023
Route 92 Medical Full Length 054 Access System
K231583 · QJP
Route 92 Medical, Inc.
Neurology · 76d
Cleared Aug 15, 2023
Implant-One System
K231455 · NHA
Implant Logistics, Inc.
Dental · 89d
Cleared Aug 15, 2023
Vscan Air
K231301 · IYN
GE Medical Systems Ultrasound and...
Radiology · 102d
Cleared Aug 15, 2023
Annalise Enterprise CTB Triage-OH
K231094 · QAS
Annalise-Ai Pty , Ltd.
Radiology · 119d
Cleared Aug 15, 2023
BAROguard
K223874 · KDN
Paragonix Technologies
Gastroenterology & Urology · 235d
Cleared Aug 14, 2023
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal...
K232311 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 12d
Cleared Aug 14, 2023
Autotome Pro RX 39 Sphincterotome
K232162 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 24d
Cleared Aug 14, 2023
Electro-Spec Steri-Caps
K231905 · HTY
Electro-Spec, Inc.
Orthopedic · 46d
Cleared Aug 14, 2023
DESS Dental Smart Solutions
K231434 · NHA
Terrats Medical SL
Dental · 89d
Cleared Aug 14, 2023
ENDOGATOR™ Hybrid Irrigation Tubing
K231418 · OCX
Medivators
Gastroenterology & Urology · 90d
Cleared Aug 14, 2023
Organic cotton tampon, Viscose tampon
K231341 · HEB
Zhejiang Tianqing Manufacturing...
Obstetrics & Gynecology · 97d