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
9409–9432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 28, 2023
Precision GI
K231422 · FCG
Limaca Medical, Ltd.
Gastroenterology & Urology · 103d
Cleared Aug 28, 2023
QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular...
K230221 · IYX
Versant Medical Physics and Radiation...
Radiology · 214d
Cleared Aug 28, 2023
SoundBite® Crossing System XS Peripheral
K230159 · PDU
Soundbite Medical Solutions, Inc.
Cardiovascular · 221d
Cleared Aug 28, 2023
VisAble.IO
K223639 · QTZ
Techsomed
Radiology · 266d
Cleared Aug 28, 2023
Alveoair Digital Spirometer
K222525 · BZG
Roundworks Technologies Private Limited
Anesthesiology · 371d
Cleared Aug 25, 2023
OMNI Surgical System
K232214 · MRH
Sight Sciences, Inc.
Ophthalmic · 30d
Cleared Aug 25, 2023
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K231994 · JWY
Thermo Fisher Scientific
Microbiology · 51d
Cleared Aug 25, 2023
Montage-QS Settable, Resorbable Bone Putty
K231903 · MQV
Orthocon, Inc.
Orthopedic · 58d
Cleared Aug 25, 2023
Polaris Bipolar Electrosurgical Generator (29-1000)
K231872 · GEI
Kirwan Surgical Products, LLC
General & Plastic Surgery · 60d
Cleared Aug 25, 2023
NovoFine® Plus
K231255 · FMI
Novo Nordisk, Inc.
General Hospital · 116d
Cleared Aug 25, 2023
Non absorbable Surgical Polyester Suture
K231183 · GAT
Shandong Haidike Medical Products...
General & Plastic Surgery · 121d
Cleared Aug 25, 2023
Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
K230928 · OWQ
Vein 360, LLC
Cardiovascular · 144d
Cleared Aug 25, 2023
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully...
K230566 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 177d
Cleared Aug 25, 2023
Wrist Type Blood Pressure Monitor (W05,W1101L)
K230409 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 191d
Cleared Aug 25, 2023
VitalFlow™ Console
K230364 · QNR
Michigan Critical Care Consultants,...
Cardiovascular · 196d
Cleared Aug 25, 2023
Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé...
K230165 · EZD
Coloplast
Gastroenterology & Urology · 217d
Cleared Aug 25, 2023
Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors
K230094 · MBI
Responsive Arthroscopy, LLC
Orthopedic · 225d
Cleared Aug 25, 2023
MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100,...
K230014 · QPL
Tonica Elektronik A/S
Physical Medicine · 234d
Cleared Aug 25, 2023
VitalFlowTM Centrifugal Pump
K223898 · QNR
Michigan Critical Care Consultants,...
Cardiovascular · 240d
Cleared Aug 25, 2023
Reusable Temperature Probe, Disposable Temperature Probe
K223807 · FLL
Shenzhen Sino-K Medical Technology...
General Hospital · 248d
Cleared Aug 25, 2023
Lavieen
K223727 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 255d
Cleared Aug 25, 2023
Sterilization Wrap
K223600 · FRG
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 266d
Cleared Aug 25, 2023
AIRAscore
K223180 · LLZ
Airamed GmbH
Radiology · 318d
Cleared Aug 25, 2023
BioProtect Balloon Implant™ System
K222972 · OVB
Bioprotect, Ltd.
Radiology · 332d