FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
8281–8304 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2023
IceSeed 1.5 CX 90º Needle (H7493967433170)
K232635 · GEH
Boston Scientific
General & Plastic Surgery · 84d
Cleared Nov 22, 2023
Blood pressure monitor
K232621 · DXN
Guangdong Transtek Medical...
Cardiovascular · 85d
Cleared Nov 22, 2023
DxFLEX Flow Cytometer
K232600 · OYE
Beckman Coulter, Inc.
Immunology · 86d
Cleared Nov 22, 2023
FITme Customized Silicone Implant
K232593 · FWP
Keosan Trading Co.
General & Plastic Surgery · 89d
Cleared Nov 22, 2023
Medifun Lancing Device, Model No. LD-E1
K231797 · QRL
Medifun Corporation
General & Plastic Surgery · 155d
Cleared Nov 22, 2023
Digital Blood Pressure Monitor (Arm Type)
K231245 · DXN
Guangdong Genial Technology Co., Ltd.
Cardiovascular · 205d
Cleared Nov 22, 2023
IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement...
K230604 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 264d
Cleared Nov 22, 2023
HealiAid Dental Collagen Wound Dressing
K230529 · OLR
Maxigen Biotech, Inc.
Dental · 268d
Cleared Nov 22, 2023
Fogg System Patient Monitoring Cables
K222712 · DSA
Fogg System Company, Inc.
Cardiovascular · 440d
Cleared Nov 22, 2023
Disposable Endoscope Valves Kit
K222499 · ODC
Shanghai SeeGen Photoelectric...
Gastroenterology & Urology · 461d
Cleared Nov 21, 2023
KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
K233333 · OWN
Karl Storz SE & CO. KG
General & Plastic Surgery · 53d
Cleared Nov 21, 2023
MagnetOs Flex Matrix
K233245 · MQV
Kuros Biosciences B.V
Orthopedic · 54d
Cleared Nov 21, 2023
TotalTi ACDF by SAGICO
K233191 · OVE
Spinal Analytics & Geometrical...
Orthopedic · 54d
Cleared Nov 21, 2023
Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT...
K233084 · ODP
Gbs Commonwealth Co., Ltd.
Orthopedic · 56d
Cleared Nov 21, 2023
DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size...
K233053 · MUH
Dental Imaging Technologies Corporation
Radiology · 57d
Cleared Nov 21, 2023
TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant...
K233049 · PSW
Cs Medical, LLC
General Hospital · 57d
Cleared Nov 21, 2023
Beagank 4T Plus
K233010 · NFO
Belega, Inc.
Neurology · 60d
Cleared Nov 21, 2023
Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System
K232988 · IYN
Canon Medical Systems Corporation
Radiology · 60d
Cleared Nov 21, 2023
Biophotas Celluma CONTOUR
K232977 · OLI
Biophotas, Inc.
General & Plastic Surgery · 61d
Cleared Nov 21, 2023
Quantisal™ Oral Fluid Collection Device
K232898 · PJD
Immunalysis Corporation
Chemistry · 64d
Cleared Nov 21, 2023
ProMIS Extension Rod System
K232719 · NKB
Premia Spine, Ltd.
Orthopedic · 77d
Cleared Nov 21, 2023
Medical Nitrile Examination Gloves
K232576 · LZA
Jiangsu Complete Sincerity Medical...
General Hospital · 88d
Cleared Nov 21, 2023
INFINITI™ Ambi Angiographic Catheter
K232573 · DQO
Cordis US Corp
Cardiovascular · 88d
Cleared Nov 21, 2023
NemoCast
K232549 · PNN
Software Nemotec S.L.
Dental · 90d