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
8161–8184 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 04, 2024
Pursuant Health Kiosk (G1.D5)
K230996 · DXN
Pursuant Health
Cardiovascular · 272d
Cleared Jan 04, 2024
Zimed Distal Medial Tibial Plate and Screw System
K230507 · HWC
Zimed Medikal
Orthopedic · 314d
Cleared Jan 04, 2024
Pulse Oximeter(Model OHT60,OXH78)
K230277 · DQA
Cofoe Medical Technology Co., Ltd.
Anesthesiology · 337d
Cleared Jan 04, 2024
Dayspring
K223228 · JOW
Koya Medical, Inc.
Cardiovascular · 443d
Cleared Jan 04, 2024
LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial...
K221110 · FRO
Huizhou Foryou Medical Devices Co., Ltd.
General & Plastic Surgery · 629d
Cleared Jan 03, 2024
Portable Dental X-Ray (AXR60 S)
K233395 · EHD
Alliage S/A Industrias M?dico...
Radiology · 92d
Cleared Jan 03, 2024
Horos MD™
K232589 · LLZ
Icat Solutions, Ltd.
Radiology · 131d
Cleared Jan 03, 2024
REMI AI Discrete Detection Module
K231779 · OMB
Epitel, Inc.
Neurology · 201d
Cleared Jan 03, 2024
ResQ Administration Set
K231707 · FPA
Q For Plastic Industries
General Hospital · 205d
Cleared Jan 03, 2024
Carecube Negative Pressure Isolation Chamber
K231256 · LGM
Carecubes, Inc.
General Hospital · 247d
Cleared Jan 03, 2024
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA...
K223397 · LPL
Hoya Lamphun , Ltd.
Ophthalmic · 421d
Cleared Jan 02, 2024
MOSAIC 3D (Surgical Laser)
K233550 · ONG
Lutronic Aesthetic
General & Plastic Surgery · 60d
Cleared Dec 29, 2023
Precision1
K233856 · LPL
Alcon Laboratories, Inc.
Ophthalmic · 24d