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
9289–9312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 2023
Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core...
K230626 · MWI
Ge Medical Systems Information...
Anesthesiology · 157d
Cleared Aug 11, 2023
Dr. pen Microneedling System
K230420 · QAI
Guangzhou Ekai Electronic Technology...
General & Plastic Surgery · 176d
Cleared Aug 11, 2023
PolyWear® Personal Protective Level 3 Gown
K230384 · QPC
PolyConversions, Inc.
General Hospital · 178d
Cleared Aug 11, 2023
PMT Expandable Cage (PMT EXP)
K230297 · MRW
Providence Medical Technology, Inc.
Orthopedic · 190d
Cleared Aug 11, 2023
NuEra Tight RF Family
K223856 · GEI
Bios S.R.L.
General & Plastic Surgery · 231d
Cleared Aug 11, 2023
eRapid Nebulizer System
K223840 · CAF
Pari Respiratory Equipment, Inc.
Anesthesiology · 232d
Cleared Aug 11, 2023
Carex Hybrid Personal Lubricant
K223519 · NUC
Karex Industries Sdn. Bhd.
Obstetrics & Gynecology · 261d
Cleared Aug 11, 2023
Otsuka Digital Feedback Device-RW
K223463 · OZW
Otsuka America Pharmaceutical, Inc.
Cardiovascular · 268d
Cleared Aug 11, 2023
BlueStar CGM insulin dose calculator
K222888 · QRX
Welldoc, Inc.
Chemistry · 322d
Cleared Aug 10, 2023
Aura 10 PET/CT
K231420 · QXL
Xeos Medical
Radiology · 86d
Cleared Aug 10, 2023
EnSite™ X EP System
K231415 · DQK
Abbott Medical
Cardiovascular · 86d
Cleared Aug 10, 2023
AirLife DuoTherm™ Humidification System
K231380 · BTT
Vyaire Medical, Inc.
Anesthesiology · 90d
Cleared Aug 10, 2023
ReliOn Premier BLU Blood Glucose Monitoring System
K230625 · NBW
I-Sens, Inc.
Chemistry · 157d
Cleared Aug 10, 2023
Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2
K230428 · EOQ
Ambu A/S
Ear, Nose, Throat · 174d
Cleared Aug 10, 2023
ZenPro 40
K230268 · GEX
BLUECORE COMPANY Co., Ltd.
General & Plastic Surgery · 191d
Cleared Aug 10, 2023
ANNE One
K223711 · DRG
Sibel Health, Inc.
Cardiovascular · 241d
Cleared Aug 10, 2023
GEM Premier 7000 with IQM3
K223608 · CHL
Instrumentation Laboratory Company
Chemistry · 251d
Cleared Aug 10, 2023
SuperBall Meniscal Repair System
K223500 · GAT
Arcuro Medical , Ltd.
General & Plastic Surgery · 262d
Cleared Aug 10, 2023
ArtiFascia
K223445 · GXQ
Nurami Medical , Ltd.
Neurology · 269d
Cleared Aug 10, 2023
HAVAb IgG II
K222850 · LOL
Abbott Laboratories
Microbiology · 323d
Cleared Aug 10, 2023
ID NOW COVID-19 2.0
K221925 · QWR
Abbott Diagnostics Scarborough, Inc.
Microbiology · 405d
Cleared Aug 10, 2023
Accu-Chek Solo micropump system with interoperable technology
K213134 · QFG
Roche Diabetes Care GmbH
Chemistry · 682d
Cleared Aug 10, 2023
Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
K213131 · NBW
Roche Diabetes Care GmbH
Chemistry · 682d
Cleared Aug 09, 2023
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K232039 · LZA
Grand Work Plastic Products Co., Ltd.
General Hospital · 30d