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
6865–6888 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2024
F&P Optiflow Oxygen Kit (AA451J)
K233821 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 195d
Cleared Jun 13, 2024
Radiography 7300 C
K233662 · KPR
Philips Medical Systems Dmc GmbH
Radiology · 211d
Cleared Jun 13, 2024
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
K233321 · FDA
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 258d
Cleared Jun 13, 2024
AquaBplus
K232953 · FIP
Fresenius Medical Care Renal...
Gastroenterology & Urology · 266d
Cleared Jun 13, 2024
VERVE
K232930 · SBN
Oculomotor Technologies
Ophthalmic · 267d
Cleared Jun 13, 2024
ProMin Dental Desensitizing Gel
K231060 · LBH
Belport Company, Inc., Gingi-Pak
Dental · 427d
Cleared Jun 12, 2024
Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541)
K241352 · DTZ
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 12, 2024
Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System
K241034 · PML
Medacta International S.A.
Orthopedic · 57d
Cleared Jun 12, 2024
EO Chex Indicator Tape
K240910 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 71d
Cleared Jun 12, 2024
Identity Shoulder System
K240876 · MBF
Zimmer, Inc.
Orthopedic · 75d
Cleared Jun 12, 2024
RS85 Diagnostic Ultrasound System
K240516 · IYN
Samsung Medison Co., Ltd.
Radiology · 110d
Cleared Jun 12, 2024
PLASMA EDGE System
K240504 · FAS
Lamidey Noury Medical
Gastroenterology & Urology · 112d
Cleared Jun 12, 2024
Remunity System
K240256 · QJY
Deka Research and Development
General Hospital · 133d
Cleared Jun 12, 2024
SOUNDSTAR™ CRYSTAL Ultrasound Catheter
K240050 · OBJ
Biosense Webster, Inc.
Cardiovascular · 156d
Cleared Jun 12, 2024
ACUSON SC2000 Diagnostic Ultrasound System
K233613 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 212d
Cleared Jun 12, 2024
ACUSON P500 Ultrasound System
K233610 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 212d
Cleared Jun 12, 2024
MEDIBLU ECG SYSTEM
K233266 · DPS
Mediblu Medical, LLC
Cardiovascular · 257d
Cleared Jun 12, 2024
Picosecond Nd:YAG Laser System
K233007 · GEX
Ami, Inc.
General & Plastic Surgery · 264d
Cleared Jun 12, 2024
VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
K232967 · NGZ
bioMerieux, Inc.
Microbiology · 265d
Cleared Jun 12, 2024
Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile...
K232950 · FMF
Perfect Medical Industry (Vn) Co., Ltd.
General Hospital · 266d
Cleared Jun 11, 2024
MetriCide™ OPA Plus Solution Test Strip
K241344 · JOJ
Steris
General Hospital · 29d
Cleared Jun 11, 2024
JADE PLUS PTA Balloon Dilatation Catheter
K241025 · LIT
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 57d
Cleared Jun 11, 2024
Mako Total Knee Application
K241011 · OLO
Mako Surgical Corp.
Orthopedic · 60d
Cleared Jun 11, 2024
DOOPANG
K232749 · PCC
Ybrain, Inc.
Neurology · 277d