Search FDA 510(k) Devices

5,409 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
601–624 of 3,225
Cleared Oct 23, 2025
Picosecond Laser Device (PF131-BI)
K252345 · GEX
Risu Medical Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared Oct 23, 2025
PerQseal Introducers
K252309 · DYB
Vivasure Medical Limited
Cardiovascular · 91d
Cleared Oct 23, 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs,...
K250861 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 216d
Cleared Oct 23, 2025
TeraRecon Cardiovascular.Calcification.CT
K250288 · QIH
Terarecon,Inc.
Radiology · 265d
Cleared Oct 22, 2025
FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone...
K253147 · MQV
Prosidyan, Inc.
Orthopedic · 27d
Cleared Oct 22, 2025
Pre-Sutured Tendon
K253145 · GAT
Rti Surgical, Inc.
Orthopedic · 27d
Cleared Oct 22, 2025
Freedom® Total Knee System – Titan PCK Components
K253144 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 27d
Cleared Oct 22, 2025
Carrier XL Delivery Catheter
K252569 · QJP
Balt USA, LLC
Neurology · 69d
Cleared Oct 22, 2025
QIAstat-Dx Gastrointestinal Panel 2
K252329 · PCH
QIAGEN GmbH
Microbiology · 89d
Cleared Oct 22, 2025
Hair Growth Laser Cap
K252325 · OAP
Cosmo Far East Technology Limited
General & Plastic Surgery · 89d
Cleared Oct 22, 2025
SIros-X System
K252322 · OUR
Genesys Spine
Orthopedic · 89d
Cleared Oct 22, 2025
ANDI 2.0
K252298 · QIH
Imeka Solutions, Inc.
Radiology · 91d
Cleared Oct 22, 2025
electric breast pump (FZ-P8)
K251977 · HGX
Ningbo Youhe Electrical Appliance...
Obstetrics & Gynecology · 117d
Cleared Oct 22, 2025
Flowflex Plus RSV + Flu A/B + COVID Home Test
K251749 · SCA
ACON Laboratories, Inc.
Microbiology · 138d
Cleared Oct 22, 2025
Giraffe OmniBed Carestation (CS1)
K251663 · FMZ
Datex-Ohmeda, Inc.
General Hospital · 145d
Cleared Oct 22, 2025
Mandibular Advancement Device L07
K251628 · LRK
Dcstar, Inc.
Dental · 147d
Cleared Oct 22, 2025
WELLlife COVID-19 Antigen Test Rx
K251289 · QVF
Guangzhou Wondfo Biotech Co., Ltd.
Microbiology · 180d
Cleared Oct 22, 2025
Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018,...
K251185 · QEW
Intervene
Cardiovascular · 189d
Cleared Oct 22, 2025
Sirona Advanced Imaging Suite
K251030 · LLZ
Sirona Medical
Radiology · 202d
Cleared Oct 22, 2025
XC11 ICE System, USA
K250955 · OBJ
Yorlabs, Inc.
Cardiovascular · 205d
Cleared Oct 22, 2025
Alegria Flash CTD Screen
K250666 · LLL
Zeus Scientific
Immunology · 231d
Cleared Oct 21, 2025
TriALTIS™ Spine System
K253249 · NKB
Medos International SARL
Orthopedic · 22d
Cleared Oct 21, 2025
Aevumed FASE Suture Anchor
K253040 · MBI
Aevumed, Inc.
Orthopedic · 29d
Cleared Oct 21, 2025
HemoSphere Stream Module
K253034 · DQK
Edwards Lifesciences
Cardiovascular · 29d