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
10201–10224 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 2023
RGS
K222702 · FRA
Genesis Air, Inc.
General Hospital · 268d
Cleared Jun 02, 2023
Breathe+
K222018 · BWF
Peep Medical, LLC Dba Go2 Devices
Anesthesiology · 329d
Cleared Jun 02, 2023
ADVIA Centaur® Anti-Müllerian Hormone (AMH)
K221801 · PQO
Siemens Healthcare Diagnostics, Inc.
Toxicology · 346d
Cleared Jun 02, 2023
vWF Ag
K220728 · GGP
Siemens Healthcare Diagnostics...
Hematology · 445d
Cleared Jun 02, 2023
Volumat Line
K220301 · FPA
Fresenius Kabi
General Hospital · 485d
Cleared Jun 01, 2023
FiberTak® Suture Anchor
K231330 · MBI
Arthrex, Inc.
Orthopedic · 24d
Cleared Jun 01, 2023
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
K231306 · QQX
Roche Molecular Systems, Inc.
Microbiology · 27d
Cleared Jun 01, 2023
Drakon™ and Sequre® Microcatheters
K231293 · DQO
Accurate Medical Therapeutics
Cardiovascular · 28d
Cleared Jun 01, 2023
Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
K230990 · GEX
Candela Corporation
General & Plastic Surgery · 56d
Cleared Jun 01, 2023
HardyDisk AST Rezafungin 5µg (RZF5)
K230827 · JTN
Hardy Diagnostics
Microbiology · 66d
Cleared Jun 01, 2023
Surgical Face Mask (L 175*95mm)
K230617 · FXX
Henan Chaoya Medical Equipment Co., Ltd.
General Hospital · 87d
Cleared Jun 01, 2023
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM)
K230408 · JKA
Sb-Kawasumi Laboratories, Inc.
General Hospital · 106d
Cleared Jun 01, 2023
ANT-X System
K230185 · OWB
Ndr Medical Technology Pte. , Ltd.
Radiology · 129d
Cleared Jun 01, 2023
Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna...
K223929 · QEW
Innova Vascular, Inc.
Cardiovascular · 153d
Cleared Jun 01, 2023
SomniCheck
K223676 · GWL
Brainmatterz, LLC
Neurology · 175d
Cleared Jun 01, 2023
Brainomix 360 e-CTP
K223555 · LLZ
Brainomix Limited
Radiology · 185d
Cleared Jun 01, 2023
Radius VSM and Accessories
K223498 · MHX
Masimo Corporation
Cardiovascular · 192d
Cleared Jun 01, 2023
OmniTom Elite
K223447 · JAK
Neurologica Corporation, A Subsidiary...
Radiology · 198d
Cleared Jun 01, 2023
Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu®...
K223299 · EOQ
Ambu A/S
Ear, Nose, Throat · 217d
Cleared Jun 01, 2023
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps...
K222905 · MMK
Ningbo Maxcon Medical Technology Co.,...
General Hospital · 251d
Cleared May 31, 2023
Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching)
K231326 · MAI
Osteonic Co., Ltd.
Orthopedic · 23d
Cleared May 31, 2023
iRoot SP Plus
K231259 · KIF
Innovative Bioceramix, Inc.
Dental · 30d
Cleared May 31, 2023
Pitch PaSoft Tissue Reinforcement Device
K230671 · FTL
Xiros, Ltd.
General & Plastic Surgery · 82d
Cleared May 31, 2023
Disposable Nitrile Gloves (ABC-DG01)
K230542 · LZA
Huizhou Anboson Technology Co., Ltd.
General Hospital · 92d