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
9817–9840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2023
Zavation ALIF System
K230731 · OVD
Zavation Medical Products, LLC
Orthopedic · 90d
Cleared Jun 14, 2023
Single-use Flexible Rhinolaryngoscope
K230536 · EOB
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 107d
Cleared Jun 14, 2023
Electronic Blood Pressure Monitor
K223291 · DXN
Shenzhen Pango Medical Electronics...
Cardiovascular · 231d
Cleared Jun 14, 2023
Niti-S Duodenal Stent
K223067 · MUM
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 264d
Cleared Jun 14, 2023
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus...
K222822 · BZE
Draegerwerk AG & CO Kgaa
Anesthesiology · 268d
Cleared Jun 14, 2023
F65 Laser System
K222790 · OAP
Lumenis Be, Ltd.
General & Plastic Surgery · 272d
Cleared Jun 14, 2023
IR SLA Type Implant System
K222144 · DZE
Biotem Co., Ltd.
Dental · 329d
Cleared Jun 14, 2023
Synexis Sphere Rx
K221540 · FRA
Synexis, LLC
General Hospital · 383d
Cleared Jun 13, 2023
Axis Anterior Cervical Plate System
K231145 · KWQ
Southern Medical (Pty) , Ltd.
Orthopedic · 53d
Cleared Jun 13, 2023
SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1...
K230759 · QRK
Bosungmeditech Co., Ltd.
General & Plastic Surgery · 85d
Cleared Jun 13, 2023
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with...
K230573 · LYY
Kossan International Sdn Bhd
General Hospital · 104d
Cleared Jun 13, 2023
OptiVu™ ROSA® MxR
K230567 · SBF
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 104d
Cleared Jun 13, 2023
CAC Software
K230112 · JAK
Imbio, Inc.
Radiology · 147d
Cleared Jun 13, 2023
iOrtho
K223518 · PNN
Shanghai EA Medical Instruments Co.,...
Dental · 202d
Cleared Jun 13, 2023
Clear Aligner
K223517 · NXC
Wuxi EA Medical Instruments...
Dental · 202d
Cleared Jun 13, 2023
Tisuthes e-PTFE Surgical Patch
K201153 · OWR
Shanghai Suokang Medical Implants...
General & Plastic Surgery · 1139d
Cleared Jun 12, 2023
RxSight Insertion Device
K231466 · MSS
Rxsight, Inc.
Ophthalmic · 24d
Cleared Jun 12, 2023
Pounce™ Thrombectomy System
K231022 · QEW
Surmodics,Inc.
Cardiovascular · 63d
Cleared Jun 12, 2023
Cut Screw - Percutaneous Compression Screw
K230397 · HWC
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 118d
Cleared Jun 12, 2023
SecurePortIV Advanced Catheter Securement Adhesive
K223669 · NZP
Adhezion Biomedical, LLC
General Hospital · 187d
Cleared Jun 12, 2023
Atellica® CH Diazo Direct Bilirubin (D_DBil)
K223078 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 255d
Cleared Jun 12, 2023
Genadyne Hybrid Foam Dressings
K221888 · OMP
Genadyne Biotechnologies, Inc.
General & Plastic Surgery · 348d
Cleared Jun 12, 2023
SpiroHome Personal, SpiroHome Clinic
K213754 · BZG
Inofab Saglik Teknolojileri A.S
Anesthesiology · 559d
Cleared Jun 10, 2023
BMR 1900 PHISIO
K223361 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 219d