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
8257–8280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 2023
Monarch Bronchoscope
K231473 · QNW
Auris Health, Inc., A Johnson and...
Ear, Nose, Throat · 190d
Cleared Nov 28, 2023
Digital Blood Pressure Monitor
K231250 · DXN
Guangdong Genial Technology Co., Ltd.
Cardiovascular · 211d
Cleared Nov 28, 2023
C.A.R.E. Appliance (DNA, mRNA, mmRNA)
K230947 · LRK
Vivos Therapeutics, Inc.
Dental · 238d
Cleared Nov 28, 2023
VersaPump Infusion System
K230883 · PKP
Emed Technologies Corporation
General Hospital · 243d
Cleared Nov 28, 2023
Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
K222845 · MQC
Frey Oral Technologies, LLC
Dental · 433d
Cleared Nov 27, 2023
SteriCap Safety Needle
K233343 · FMI
Ocuject, LLC
General Hospital · 59d
Cleared Nov 27, 2023
Statera-C™ Spinal System
K233332 · NKG
K&J Consulting Corp.
Orthopedic · 59d
Cleared Nov 27, 2023
ClearPoint System (Software Version 2.2)
K233243 · HAW
ClearPoint Neuro, Inc.
Neurology · 60d
Cleared Nov 27, 2023
PF Keep
K233171 · EBI
Clemde SA DE CV
Dental · 60d
Cleared Nov 27, 2023
T-Top 10 & T-Top T-Top 11
K232658 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 88d
Cleared Nov 27, 2023
CardioPhase® hsCRP
K232624 · DCN
Siemens Healthcare Diagnostic...
Immunology · 90d
Cleared Nov 27, 2023
Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo...
K232222 · NVK
Medency S.R.L.
Dental · 124d
Cleared Nov 27, 2023
CryoThin™ Surgical System and Accessories
K231661 · GEH
Medinux (Tianjin) Technologies Co., Ltd.
General & Plastic Surgery · 173d
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