FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
8953–8976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 12, 2023
Stable-L Standalone Lumbar Interbody System
K231486 · OVD
Nexus Spine, LLC
Orthopedic · 142d
Cleared Oct 12, 2023
MONTAGE-QS Settable, Resorbable Bone Putty
K231475 · GXP
Orthocon, Inc.
Neurology · 143d
Cleared Oct 12, 2023
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic...
K231231 · HWC
Paragon 28, Inc.
Orthopedic · 167d
Cleared Oct 12, 2023
Collagen Wound Dressing
K231152 · KGN
Winner Medical Co., Ltd.
General & Plastic Surgery · 171d
Cleared Oct 12, 2023
Exactech® Vantage® Total Ankle System
K230717 · HSN
Exactech, Inc.
Orthopedic · 211d
Cleared Oct 12, 2023
Skypro, Surgical Gown 6021
K230707 · FYA
Skypro Medical Supplies Company
General Hospital · 212d
Cleared Oct 12, 2023
Monopolar Electrode Surgical Instrument
K230650 · GEI
Vhmed (Nantong) Co. , Ltd.
General & Plastic Surgery · 217d
Cleared Oct 12, 2023
Artemis, Artemis TPO, Artemis MX
K222222 · QTZ
Eigen
Radiology · 444d
Cleared Oct 11, 2023
EMPHASYS Femoral Stems
K233233 · LZO
Depuy Ireland UC
Orthopedic · 13d
Cleared Oct 11, 2023
Synq Software Version 1.3
K232981 · LNH
Synaptive Medical, Inc.
Radiology · 20d
Cleared Oct 11, 2023
VASSALLO GT 018 G12
K232578 · DQX
Filmec Co. , Ltd.
Cardiovascular · 47d
Cleared Oct 11, 2023
VASSALLO GT Crossing14
K232574 · DQX
Filmec Co. , Ltd.
Cardiovascular · 47d
Cleared Oct 11, 2023
IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
K232499 · OHT
Shenzhen Lescolton Electrical...
General & Plastic Surgery · 55d
Cleared Oct 11, 2023
Disposable electrosurgical pencil (MD1000)
K232460 · GEI
Shenzhen Mecun Medical Supply Co., Ltd.
General & Plastic Surgery · 57d
Cleared Oct 11, 2023
Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
K232344 · OWB
GE Medical Systems SCS
Radiology · 68d
Cleared Oct 11, 2023
JO Coconut Hybrid Warming Personal Lubricant
K232090 · NUC
CC Wellness, LLC
Obstetrics & Gynecology · 90d
Cleared Oct 11, 2023
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy...
K232070 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 91d
Cleared Oct 11, 2023
Arm Blood Pressure Monitor
K231050 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 181d
Cleared Oct 11, 2023
Anterion
K230897 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 194d
Cleared Oct 11, 2023
MegaGen Dental Implant Systems Portfolio - MR Conditional
K230618 · DZE
Megagen Implant Co., Ltd.
Dental · 219d
Cleared Oct 11, 2023
NeuViz 128 Multi-Slice CT Scanner System
K230220 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 258d
Cleared Oct 11, 2023
Vlab
K230148 · GWL
Dormotech Medical, Ltd.
Neurology · 265d
Cleared Oct 11, 2023
Vital™ Spinal Fixation System
K230116 · NKB
Zimvie Spine (Zimmer Biomet Spine, Inc.)
Orthopedic · 267d
Cleared Oct 11, 2023
SurgiAid® Collagen Wound Dressing
K223126 · KGN
Maxigen Biotech, Inc.
General & Plastic Surgery · 373d