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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13465–13488 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 2022
VERIQA
K213370 · IYE
Ptw-Freiburg...
Radiology · 169d
Cleared Mar 30, 2022
CareTaker Monitor App
K213699 · DXN
Caretaker Medical, LLC
Cardiovascular · 127d
Cleared Mar 30, 2022
BD Trek Powered Bone Biopsy System
K213896 · KNW
Bard Peripheral Vascular
General & Plastic Surgery · 106d
Cleared Mar 30, 2022
EL CAPITAN Anterior Lumbar Interbody Fusion System
K214047 · OVD
Astura Medical
Orthopedic · 93d
Cleared Mar 30, 2022
VSP Bolus
K214093 · IXI
3D Systems
Radiology · 92d
Cleared Mar 30, 2022
Aggeris™-C
K220182 · KWQ
Clariance
Orthopedic · 68d
Cleared Mar 30, 2022
Empulse R90
K220213 · ITI
Sunrise Medical (Us), LLC
Physical Medicine · 63d
Cleared Mar 29, 2022
Reliance Cervical IBF System
K202266 · ODP
Reliance Medical Systems, LLC
Orthopedic · 595d
Cleared Mar 29, 2022
Dukal Corporation Level 1 Pediatric Face Mask
K210321 · OXZ
Dukal Corporation
General Hospital · 418d
Cleared Mar 29, 2022
Focus HD 43 Detector
K213529 · MQB
Iray Technology Taicang , Ltd.
Radiology · 145d
Cleared Mar 29, 2022
Focus HD 35 Detector
K213646 · MQB
Iray Technology Taicang , Ltd.
Radiology · 145d
Cleared Mar 29, 2022
GAL-1A Plus Blood Glucose Monitoring System
K213887 · NBW
Apex BioTechnology Corp.
Chemistry · 106d
Cleared Mar 29, 2022
Guidewire Locking Device
K220247 · ODC
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 60d
Cleared Mar 29, 2022
REAL INTELLIGENCE CORI
K220255 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 57d
Cleared Mar 28, 2022
SancDam Latex Oral Dam
K212037 · MSC
Sanctuary Health Sdn. Bhd.
Obstetrics & Gynecology · 271d
Cleared Mar 28, 2022
Syngo.CT Dual Energy
K212889 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 199d
Cleared Mar 28, 2022
CERABIEN MiLai
K213147 · EIH
Kuraray Noritake Dental, Inc.
Dental · 182d
Cleared Mar 28, 2022
OSSIOfiber Suture Anchor
K213415 · MAI
OSSIO , Ltd.
Orthopedic · 160d
Cleared Mar 28, 2022
Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy...
K213662 · LZA
Taishan Weibang Medical Equipment...
General Hospital · 126d
Cleared Mar 28, 2022
T3 Pro Implants
K213672 · DZE
Biomet 3i, LLC
Dental · 126d
Cleared Mar 28, 2022
Hand-held IPL device(JOVS Graphene Hair Removal Device)
K214113 · OHT
Shenzhen Qianyu Technology Co., Ltd.
General & Plastic Surgery · 88d
Cleared Mar 27, 2022
GGM Breathing Circuit Bacterial Filter
K210352 · CAH
Great Group Medical Co, Ltd.
General Hospital · 412d
Cleared Mar 26, 2022
Clover Glove
K213729 · LZA
Clover Glove Company Limited
General Hospital · 120d
Cleared Mar 26, 2022
Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with...
K220215 · LZA
Ksg Medicare Sdn. Bhd.
General Hospital · 59d