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
7873–7896 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 2024
HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT*...
K232894 · FXX
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 112d
Cleared Jan 08, 2024
LungQ v3.0.0
K232412 · JAK
Thirona BV
Radiology · 151d
Cleared Jan 08, 2024
Air Gap Fiber
K232106 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 178d
Cleared Jan 08, 2024
DASI Dimensions (V1.0)
K231324 · QIH
Dasi Simulations
Radiology · 245d
Cleared Jan 07, 2024
Lifetech Cardio Temporary Pacemaker
K232721 · DTE
Shenzhen Lifetech Cardio Medical...
Cardiovascular · 124d
Cleared Jan 07, 2024
Teleport XT Microcatheter
K231608 · DQY
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 219d
Cleared Jan 07, 2024
autoSCORE
K231068 · OMB
Holberg Eeg AS
Neurology · 268d
Cleared Jan 05, 2024
IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04...
K233679 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 50d
Cleared Jan 05, 2024
DESS Dental Smart Solutions
K233316 · NHA
Terrats Medical SL
Dental · 98d
Cleared Jan 05, 2024
NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and...
K233229 · NEZ
Anx Robotica Corporation
Gastroenterology & Urology · 99d
Cleared Jan 05, 2024
ENDOCOLLECT Specimen Retrieval Bag
K232519 · GCJ
Ximedica
General & Plastic Surgery · 140d
Cleared Jan 05, 2024
VEA Align
K231917 · QIH
Eos Imaging
Radiology · 190d
Cleared Jan 05, 2024
ArcherQA (V1.0)
K231273 · IYE
Wisdom Technologies., Inc.
Radiology · 248d
Cleared Jan 05, 2024
Fusion Core DC Flo
K231263 · EBF
Prevest Denpro Limited
Dental · 248d
Cleared Jan 05, 2024
HS Fiber Sutures
K231163 · GAT
Riverpoint Medical
General & Plastic Surgery · 256d
Cleared Jan 05, 2024
Solon
K221766 · GEX
Lmg Lasers Comercio, Importacao E...
General & Plastic Surgery · 567d
Cleared Jan 04, 2024
Ambu® aScope™ 5 Broncho 4.2/2.2
K233671 · EOQ
Ambu A/S
Ear, Nose, Throat · 50d
Cleared Jan 04, 2024
LED Eye mask (EY-20R, A20, EY-20N)
K233556 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 59d
Cleared Jan 04, 2024
Butterfly iQ3 Ultrasound System
K232808 · IYN
Butterfly Network, Inc.
Radiology · 114d
Cleared Jan 04, 2024
Lancing System
K232330 · QRK
Ningbo Medsun Medical Co., Ltd.
General & Plastic Surgery · 154d
Cleared Jan 04, 2024
syngo.CT Applications
K232136 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 170d
Cleared Jan 04, 2024
Anthogyr FlexiBase® titanium bases for Axiom® BL
K231072 · NHA
Anthogyr
Dental · 265d
Cleared Jan 04, 2024
Hudson RCI® AddiPak® Unit Dose Vial
K231058 · CAF
Medline Industries, LP
Anesthesiology · 266d
Cleared Jan 04, 2024
CEPTRE® Knotted UHMWPE Suture PEEK Anchor
K231033 · MBI
Healthium Medtech Limited
Orthopedic · 268d