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
8233–8256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 29, 2023
MULTIX Impact E
K233532 · KPR
Siemens Medical Solutions
Radiology · 27d
Cleared Nov 29, 2023
Minuteman G5 MIS Fusion Plate
K233527 · PEK
Spinal Simplicity, LLC
Orthopedic · 28d
Cleared Nov 29, 2023
Blood Pressure Cuff...
K232772 · DXQ
Shenzhen Plinma Technology Co. , Ltd.
Cardiovascular · 79d
Cleared Nov 29, 2023
Surgify Halo
K232684 · HBE
Surgify Medical OY
Neurology · 89d
Cleared Nov 29, 2023
Disposable Endoscope Valves System
K232244 · ODC
Changzhou Endoclean Medical Device...
Gastroenterology & Urology · 124d
Cleared Nov 29, 2023
Expandable Lumbar Fusion Cage (Type I,Type II)
K232069 · MAX
Shanghai Reach Medical Instrument Co,...
Orthopedic · 140d
Cleared Nov 29, 2023
HYBRIDknife® flex
K232033 · GEI
Erbe Elektromedizin GmbH
General & Plastic Surgery · 145d
Cleared Nov 29, 2023
XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S,...
K231821 · KRA
Transit Scientific, LLC
Cardiovascular · 161d
Cleared Nov 29, 2023
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with...
K231482 · JAK
Shanghai United Imaging Healthcare...
Radiology · 190d
Cleared Nov 29, 2023
Mosie Baby Kit
K231203 · QYZ
Mosie Baby
Obstetrics & Gynecology · 216d
Cleared Nov 29, 2023
CEREGLIDE 92 Intermediate Catheter
K230726 · QJP
Cerenovus, Inc.
Neurology · 258d
Cleared Nov 29, 2023
SUREcore Prime Biopsy Instrument
K230646 · KNW
Uro-1 Medical, Inc.
Gastroenterology & Urology · 266d
Cleared Nov 29, 2023
6440 MyLabX90
K230179 · IYN
Esaote, S.P.A.
Radiology · 310d
Cleared Nov 28, 2023
Tricera Arthroscopic System
K233493 · GEI
Relign Corporation
Orthopedic · 29d
Cleared Nov 28, 2023
Shoreline ACS Interbody System
K233414 · OVE
SeaSpine Orthopedics Corporation
Orthopedic · 49d
Cleared Nov 28, 2023
Blood Pressure Monitor
K232713 · DXN
Guangdong Transtek Medical...
Cardiovascular · 84d
Cleared Nov 28, 2023
Cue COVID-19 Molecular Test
K232643 · QWB
Cue Health, Inc.
Microbiology · 90d
Cleared Nov 28, 2023
Gold Probe Bipolar Electrohemostasis Catheter
K232633 · KNS
Boston Scientific
Gastroenterology & Urology · 90d
Cleared Nov 28, 2023
Kinos Axiom Total Ankle System
K232595 · HSN
Restor3d
Orthopedic · 95d
Cleared Nov 28, 2023
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K232252 · LZA
Dehai (Shandong) Medical Gloves, Co.,...
General Hospital · 123d
Cleared Nov 28, 2023
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
K232117 · GEX
Wuhan Lotuxs Technology Co., Ltd.
General & Plastic Surgery · 134d
Cleared Nov 28, 2023
N1
K232012 · EHD
Osstem Implant Co., Ltd.
Radiology · 145d
Cleared Nov 28, 2023
syngo.via MI Workflows
K232000 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 146d
Cleared Nov 28, 2023
BriefCase-Quantification
K231631 · JAK
Aidoc Medical , Ltd.
Radiology · 176d