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
24121–24144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2018
Full Automatic(NIBP) Blood Pressure Monitor
K180240 · DXN
Health & Life Co., Ltd.
Cardiovascular · 261d
Cleared Oct 17, 2018
Uroject12 Syringe Lever
K180345 · QBL
Urogen Pharma, Ltd.
Gastroenterology & Urology · 251d
Cleared Oct 17, 2018
Ortho System
K180941 · PNN
3Shape A/S
Dental · 203d
Cleared Oct 17, 2018
OsteoBridge™ IDSF System
K181026 · HSB
Merete GmbH
Orthopedic · 182d
Cleared Oct 17, 2018
Muscle Trainer
K181728 · NGX
Shenzhen Kentro Medical Electronics...
Physical Medicine · 110d
Cleared Oct 17, 2018
Arterys MICA
K182034 · LLZ
Arterys, Inc.
Radiology · 79d
Cleared Oct 17, 2018
PASS LP Spinal System
K182240 · NKB
Medicrea International SA
Orthopedic · 58d
Cleared Oct 17, 2018
Alphenix, INFX-8000H/B, V8.0
K182546 · OWB
Canon Medical Systems Corporation
Radiology · 30d
Cleared Oct 17, 2018
Wireless Digital Flat Panel Detector
K182550 · MQB
Iray Technology Taicang , Ltd.
Radiology · 30d
Cleared Oct 17, 2018
Wireless Digital Flat Panel Detector
K182551 · MQB
Iray Technology Taicang , Ltd.
Radiology · 30d
Cleared Oct 17, 2018
Youlaser CO2
K182669 · GEX
Quanta System Spa
General & Plastic Surgery · 22d
Cleared Oct 16, 2018
KidCap
K180568 · MVA
Eastern Cranial Affiliates, LLC
Neurology · 225d
Cleared Oct 16, 2018
QUANTA Flash Calprotectin and Fecal Extraction Device
K180971 · NXO
Inova Diagnostics, Inc.
Immunology · 186d
Cleared Oct 16, 2018
Pump In Style Advanced, Advanced Personal Double Breastpump
K181937 · HGX
Medela, LLC
Obstetrics & Gynecology · 89d
Cleared Oct 16, 2018
Depuy Synthes Femoral Neck System
K182154 · KTT
Synthes USA Products, LLC
Orthopedic · 68d
Cleared Oct 16, 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe
K182261 · NQQ
Ninepoint Medical, Inc.
General & Plastic Surgery · 56d
Cleared Oct 16, 2018
RCT700
K182614 · OAS
Ray Co., Ltd.
Radiology · 25d
Cleared Oct 15, 2018
Reliant(TM) Multistage Dilatation Balloon Catheter
K180418 · FGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 242d
Cleared Oct 15, 2018
DynaBridge
K181815 · JDR
Fusion Orthopedics, LLC
Orthopedic · 98d
Cleared Oct 15, 2018
BracePaste MTP Light Cure Primer
K181910 · KLE
American Orthodontics
Dental · 90d
Cleared Oct 15, 2018
NeuroBlate System
K182036 · GEX
Monteris Medical,
Neurology · 77d
Cleared Oct 15, 2018
FlowTriever Retrieval/Aspiration System
K182233 · QEW
Inari Medical
Cardiovascular · 59d
Cleared Oct 12, 2018
Optilite High Sensitivity C-Reactive Protein Kit
K180099 · DCN
The Binding Site Group , Ltd.
Chemistry · 269d
Cleared Oct 12, 2018
PENTAX Video Upper G.I. Scope EG34-i10
K180292 · FDS
Pentax Medical of America, Inc.
Gastroenterology & Urology · 253d