Search FDA 510(k) Database

6,789 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
13753–13776 of 174,061
Cleared Dec 08, 2021
Infrared forehead thermometer LD-FT-100B
K211629 · FLL
Honsun (Nantong) Co., Ltd.
General Hospital · 195d
Cleared Dec 08, 2021
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
K211898 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 170d
Cleared Dec 08, 2021
ShurFit Lumbar Interbody System
K212075 · MAX
Precision Spine, Inc.
Orthopedic · 159d
Cleared Dec 08, 2021
Anteralign Spinal System with Titan nanoLOCK Surface Technology
K212524 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 119d
Cleared Dec 08, 2021
PicoLO Premium
K212573 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 114d
Cleared Dec 08, 2021
Disposable Medical Nitrile Examination Gloves (Non sterile)
K212639 · LZC
Jiangsu Nanfang Medical Co., Ltd.
General Hospital · 110d
Cleared Dec 08, 2021
Injectable Root Canal Bioceramic Sealer
K212983 · KIF
Beijing C-Root Dental Medical Devices...
Dental · 82d
Cleared Dec 08, 2021
BD Nano 2nd Gen Pen Needle
K213156 · FMI
Becton, Dickinson and Company
General Hospital · 79d
Cleared Dec 07, 2021
endomina system
K211309 · OCW
Endo Tools Therapeutics S.A.
Gastroenterology & Urology · 221d
Cleared Dec 07, 2021
BAYLAB 3-Ply Surgical Mask (BEACON I)
K212302 · FXX
Baylab USA, LLC
General Hospital · 137d
Cleared Dec 07, 2021
Comfortpro
K212438 · LYY
Thai Rubber Industry Company Limited
General Hospital · 125d
Cleared Dec 07, 2021
Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS...
K213303 · IYO
Infraredx, Inc.
Cardiovascular · 64d
Cleared Dec 07, 2021
DERMABOND PRINEO Skin Closure System
K213512 · OMD
Ethicon, Inc.
General & Plastic Surgery · 35d
Cleared Dec 06, 2021
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses,...
K211448 · LPL
Pegavision Corporation
Ophthalmic · 210d
Cleared Dec 06, 2021
PMW01 Procedure Mask Level 1
K211772 · FXX
Defender Safety, Inc.
General Hospital · 181d
Cleared Dec 06, 2021
3Delta Crown
K211804 · EBF
Deltamed GmbH
Dental · 178d
Cleared Dec 06, 2021
Surgical Face Mask
K212235 · FXX
Shanghai Yunqing Industrial Co., Ltd.
General Hospital · 140d
Cleared Dec 06, 2021
VersaTap, VersaLat, DueLock, VersaTi, MiniTi
K212381 · MBI
Ortho-Design (Pty), Ltd.
Orthopedic · 126d
Cleared Dec 06, 2021
LUXEN CL Dental Liquid
K212548 · EIH
Dentalmax Co., Ltd.
Dental · 115d
Cleared Dec 06, 2021
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with...
K212827 · LZC
Jr Engineering & Medical Technologies...
General Hospital · 94d
Cleared Dec 06, 2021
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM)...
K212852 · ODG
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Dec 06, 2021
Al-Rad Companion (Pulmonary)
K213096 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 73d
Cleared Dec 06, 2021
CHENA-C Spacer System
K213115 · ODP
Kahtnu Surgical, Inc.
Orthopedic · 70d
Cleared Dec 05, 2021
INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant...
K211561 · MUD
Covidien, LLC
Neurology · 199d