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
8545–8568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 2023
ABPMpro
K231104 · DSH
Somnomedics GmbH
Cardiovascular · 222d
Cleared Nov 27, 2023
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary...
K230493 · GIM
Becton, Dickinson and Company
Hematology · 277d
Cleared Nov 27, 2023
Portable (Ultrasonic) Nebulizer
K230379 · CAF
Dongguan Simzo Electronic Technology...
Anesthesiology · 287d
Cleared Nov 25, 2023
NeuTrace EP Mapping System v.2.1
K233160 · DQK
Anumana, Inc.
Cardiovascular · 59d
Cleared Nov 24, 2023
MF SC Facial Toning System
K233525 · NFO
Micro Current Technology, Inc.
Neurology · 23d
Cleared Nov 24, 2023
Tympanostomy Tubes
K232059 · ETD
Grace Medical, Inc.
Ear, Nose, Throat · 136d
Cleared Nov 24, 2023
Stim2Go
K230701 · IPF
PAJUNK GmbH Medizintechnologie
Physical Medicine · 255d
Cleared Nov 24, 2023
Passio Pump Drainage System
K230319 · PNG
Bearpac Medical
Gastroenterology & Urology · 291d
Cleared Nov 24, 2023
HyperSuture
K230311 · GAT
Threadstone, LLC
General & Plastic Surgery · 294d
Cleared Nov 22, 2023
Carnation Ambulatory Monitor
K233110 · DSH
Bardy Diagnostics, Inc.
Cardiovascular · 56d
Cleared Nov 22, 2023
Posterior Cervical Spine System
K233078 · NKG
Double Medical Technology, Inc.
Orthopedic · 58d
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