Search FDA 510(k) Database

6,703 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
12265–12288 of 174,061
Cleared May 27, 2022
Navagio Lumbar Cage
K220902 · MAX
Kalitec Medical, LLC
Orthopedic · 60d
Cleared May 26, 2022
Amylase2
K210633 · JFJ
Abbott Ireland Diagnostics Division
Chemistry · 449d
Cleared May 26, 2022
ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital...
K211779 · DQD
Chip Ideas Electronics S.L.
Cardiovascular · 351d
Cleared May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
K212132 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 322d
Cleared May 26, 2022
I-Motion
K212413 · NGX
I-Motion Group Global Iberica S.L.
Physical Medicine · 296d
Cleared May 26, 2022
PP Care Nitrile Examination Gloves
K212629 · LZA
Eg Group Product and Services Co., Ltd.
General Hospital · 280d
Cleared May 26, 2022
Aura Storm
K212644 · FRA
Invictus Lighting
General Hospital · 279d
Cleared May 26, 2022
Laser Hair Growth Comb
K213027 · OAP
Kam Yuen Plastic Products , Ltd.
General & Plastic Surgery · 247d
Cleared May 26, 2022
Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta...
K213171 · HIH
Meditrina, Inc.
Obstetrics & Gynecology · 240d
Cleared May 26, 2022
AMADEO, M-UK1015 (incl. attachments and accessories)
K213221 · ERL
W&H Dentalwerk Buermoss GmbH
Dental · 239d
Cleared May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
K213996 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 157d
Cleared May 26, 2022
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram...
K214074 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 150d
Cleared May 26, 2022
iFuse Bedrock Granite™ Implant System
K220195 · OUR
SI-BONE, Inc.
Orthopedic · 122d
Cleared May 26, 2022
Sterile Nitrile Powder Free Examination Gloves Tested For Use With...
K220249 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 115d
Cleared May 26, 2022
Astroglide Ultra Gentle Gel
K220355 · NUC
Biofilm, Inc.
Obstetrics & Gynecology · 107d
Cleared May 26, 2022
Powder Free Nitrile Examination Gloves, Blue, Tested for use with...
K220545 · LZC
Hl Rubber Industries Sdn Bhd
General Hospital · 90d
Cleared May 26, 2022
Wearable Breast Pump (Model S9)
K220596 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 86d
Cleared May 26, 2022
Disposable Surgical Face Mask (FM-34EE,FM-44EE)
K220597 · FXX
Qingdao Bestex Rubber & Plastic...
General Hospital · 86d
Cleared May 26, 2022
Barrigel Injectable Gel
K220641 · OVB
Palette Life Sciences
Radiology · 83d
Cleared May 25, 2022
restor3d MTP Implant
K201393 · KWD
Restor3D, Inc.
Orthopedic · 728d
Cleared May 25, 2022
OptiComp
K202920 · EBF
Pac-Dent, Inc.
Dental · 603d
Cleared May 25, 2022
CRYO Arctic, CRYO Penguin
K203661 · MLY
Cryoscience North America, Inc.
Physical Medicine · 526d
Cleared May 25, 2022
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K210655 · OWQ
Innovative Health, LLC
Cardiovascular · 447d
Cleared May 25, 2022
Well-life TM Pen Needles, Well-life TM Safety Pen Needles
K210748 · FMI
W. L. Med Co., Ltd.
General Hospital · 439d