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
6841–6864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2024
BioSieve™ Fentanyl FIA Test Kit
K240124 · DJG
Vivachek Biotech (Hangzhou) Co., Ltd.
Toxicology · 150d
Cleared Jun 14, 2024
G-Vitri™ Vitrification Straw
K240002 · MQK
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 164d
Cleared Jun 14, 2024
CanGaroo RM Antibacterial Envelope
K233991 · FTM
Elutia, Inc.
General & Plastic Surgery · 179d
Cleared Jun 14, 2024
Clarius OB AI
K233955 · IYN
Clarius Mobile Health Corp.
Radiology · 182d
Cleared Jun 14, 2024
HFT150
K233707 · BTT
Invent Medical Corporation
Anesthesiology · 207d
Cleared Jun 14, 2024
EndeavorOTC
K233496 · QFT
Akili Interactive Labs, Inc.
Neurology · 228d
Cleared Jun 14, 2024
TELIGEN System Navigation Ready Instruments
K233254 · OLO
DePuy Synthes
Orthopedic · 260d
Cleared Jun 14, 2024
Air Pressure Therapy System (Model:VU-IPC4M)
K233238 · IRP
Xiamen Weiyou Intelligent Technology...
Physical Medicine · 260d
Cleared Jun 14, 2024
Spine Navigation and Robotic-Assistance Device
K233228 · OLO
Ecential Robotics
Orthopedic · 260d
Cleared Jun 14, 2024
Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS)
K233079 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 262d
Cleared Jun 14, 2024
Smart Scope® CX
K233043 · HEX
Periwinkle Technologies Pvt., Ltd.
Obstetrics & Gynecology · 263d
Cleared Jun 14, 2024
Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket...
K232893 · KNG
Contec Medical Systems Co.,Ltd
Obstetrics & Gynecology · 270d
Cleared Jun 14, 2024
Roche Digital Pathology Dx (VENTANA DP 200)
K232879 · PSY
Ventana Medical Systems, Inc.
Pathology · 270d
Cleared Jun 14, 2024
Fluidshield* 2 Fog-Free Surgical Mask (62113)
K232812 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 276d
Cleared Jun 14, 2024
Disposable High-pressure Extension Lines
K230668 · DXT
Precision Medical Plastics , Ltd.
General Hospital · 462d
Cleared Jun 13, 2024
21.3” 5MP Color LCD Display UMD5-21B01
K241499 · PGY
Acula Technology Corp.
Radiology · 16d
Cleared Jun 13, 2024
Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)
K241370 · DYB
Abbott Medical
Cardiovascular · 30d
Cleared Jun 13, 2024
BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
K241358 · GEX
Sun Pharmaceutical Industries, Inc.
General & Plastic Surgery · 30d
Cleared Jun 13, 2024
Arthrex Cannulated Screw System
K240815 · HWC
Arthrex, Inc.
Orthopedic · 80d
Cleared Jun 13, 2024
FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
K240460 · DQX
FMD Co., Ltd.
Cardiovascular · 118d
Cleared Jun 13, 2024
Giftlife™ Fertilization Medium
K240149 · MQL
Gimbo Medical Technology Shenzhen...
Obstetrics & Gynecology · 146d
Cleared Jun 13, 2024
InMode System with the Morpheus8 90 Applicator
K240017 · GEI
Inmode , Ltd.
General & Plastic Surgery · 163d
Cleared Jun 13, 2024
Relu Creator
K233925 · QIH
Relu BV
Radiology · 183d
Cleared Jun 13, 2024
3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)
K233892 · GCJ
Zhuhai Dipu Medical Technology Co., Ltd.
General & Plastic Surgery · 188d