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
18121–18144 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 2020
Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu...
K202274 · GZB
Boston Scientific Neuromodulation
Neurology · 90d
Cleared Nov 09, 2020
iFuse Implant System - iFuse Navigation
K203110 · OLO
SI-BONE, Inc.
Orthopedic · 25d
Cleared Nov 09, 2020
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC...
K203128 · IYN
Olympus Medical Systems Corp.
Radiology · 21d
Cleared Nov 06, 2020
Medical RF
K192621 · GEI
Triworks Group Srl
General & Plastic Surgery · 410d
Cleared Nov 06, 2020
AI-Rad Companion Organs RT
K193562 · QKB
Siemens Medical Solutions USA, Inc.
Radiology · 319d
Cleared Nov 06, 2020
BioMin Restore Plus
K200077 · LBH
Dr. Collins, Inc.
Dental · 297d
Cleared Nov 06, 2020
Durex Penck Standard, Durex Penck XL
K200672 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 238d
Cleared Nov 06, 2020
Neuro.Al Algorithm
K200750 · LLZ
Terarecon,Inc.
Radiology · 228d
Cleared Nov 06, 2020
cobas u 701 microscopy analyzer
K200811 · LKM
Roche Diagnostics
Hematology · 224d
Cleared Nov 06, 2020
V-Print splint
K201091 · MQC
Voco GmbH
Dental · 197d
Cleared Nov 06, 2020
SimpleSENSE
K201669 · DXH
Nanowear, Inc.
Cardiovascular · 140d
Cleared Nov 06, 2020
Aqueduct 100 Plus Cervical Dilation Balloon Catheter
K202427 · PON
Gtimd, LLC
Obstetrics & Gynecology · 73d
Cleared Nov 06, 2020
BioShield biopsy valve EUS - Linear
K202583 · ODD
STERIS Corporation
Gastroenterology & Urology · 59d
Cleared Nov 06, 2020
ATEC Lateral Interbody System
K202587 · MAX
Alphatec Spine, Inc.
Orthopedic · 59d
Cleared Nov 06, 2020
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression...
K202589 · HWC
Medartis AG
General Hospital · 59d
Cleared Nov 06, 2020
Clio Prime and Clio Pedo
K202664 · MUH
Sota Precision Optics, Inc. Dba Sota...
Radiology · 53d
Cleared Nov 06, 2020
Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution...
K203061 · FLE
STERIS Corporation
General Hospital · 29d
Cleared Nov 06, 2020
Mecta-C Stand Alone Extension
K203076 · OVE
Medacta International S.A.
Orthopedic · 24d
Cleared Nov 05, 2020
Eclipse DermaFlex Cannula
K200017 · FMI
Eclipse Medcorp, LLC
General Hospital · 307d
Cleared Nov 05, 2020
Gabriel 3 Way EnFit Valve
K201741 · PIF
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 133d
Cleared Nov 05, 2020
GR-17 Resin System
K201827 · EBG
Pro3dure Medical GmbH
Dental · 126d
Cleared Nov 05, 2020
OtoSet- Ear Cleaning System
K201877 · KYZ
Safkan, Inc.
Ear, Nose, Throat · 121d
Cleared Nov 05, 2020
MammaPrint
K201902 · NYI
Agendia, Inc.
Pathology · 120d
Cleared Nov 05, 2020
SPY-PHI System with SPY-PHI Fluorescence Assessment Software
K202244 · OWN
Novadaq Technologies Ulc. (Now A Part...
General & Plastic Surgery · 87d