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: 2026–2026 ×
1,922 results
289–312 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jun 26, 2026
i-STAT Crea cartridge with the i-STAT 1 System
K261039 · CGL
Abbott Point of Care, Inc.
Chemistry · 88d
Cleared Jun 26, 2026
MammoScreen® (5)
K260714 · QDQ
Therapixel
Radiology · 113d
Cleared Jun 26, 2026
TENS 7000 Rechargeable 4 Channel (TENS 7000H)
K260412 · NUH
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 137d
Cleared Jun 26, 2026
BioHorizons CEREC Compatible Ti-Bases (TP3CTB1~PBCTB3 and CNTE0~CRTE2)
K260061 · NHA
BioHorizons Implant Systems, Inc.
Dental · 169d
Cleared Jun 26, 2026
Arthrex FiberButton
K260018 · MBI
Arthrex, Inc.
Orthopedic · 172d
Cleared Jun 26, 2026
ECLIPTIS Left Atrial Appendage Exclusion System (ECS135)
K254232 · PZX
Edwards Lifesciences
Cardiovascular · 179d
Cleared Jun 26, 2026
VERTICALE® Navigation Instruments
K253921 · OLO
Silony Medical GmbH
Orthopedic · 200d
Cleared Jun 26, 2026
PhAST instrument and PhAST Blood Culture Gram-negative Panel
K253316 · SAN
Phast Corp.
Microbiology · 269d
Cleared Jun 26, 2026
BioTracker 2.0
K253306
Biotracker, LLC
Cardiovascular · 270d
Cleared Jun 26, 2026
Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)
K250070 · HGX
Shenzhen Changkun Technology Co., Ltd.
Obstetrics & Gynecology · 532d
Cleared Jun 25, 2026
ATTUNE Total Knee System
K261458 · JWH
Depuy Ireland UC
Orthopedic · 55d
Cleared Jun 25, 2026
SimplGuide
K261242 · DYB
Pendracare
Cardiovascular · 71d
Cleared Jun 25, 2026
Wearable breast pump (QY-101, QY-102, QY-108)
K261025 · HGX
Shenzhen Qinyi Electronic Technology...
Obstetrics & Gynecology · 87d
Cleared Jun 25, 2026
iD3 Nav Decompression Probe (NTX-9005)
K260992 · PDQ
Neuralytix
Neurology · 91d
Cleared Jun 25, 2026
Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System
K260809 · HWC
Arthrex, Inc.
Orthopedic · 105d
Cleared Jun 25, 2026
G-Series Grind Guard
K260790 · OBR
ASESSO HEALTH, Inc.
Dental · 106d
Cleared Jun 25, 2026
ClearFit Ti Ring 14mm (171750)
K260709 · GXN
Longeviti Neuro Solutions
Neurology · 113d
Cleared Jun 25, 2026
VELYS™ Robotic-Assisted Solution
K260480 · OLO
Depuy Ireland UC
Orthopedic · 132d
Cleared Jun 25, 2026
MiPACS V5 (1.0.0)
K260231 · LLZ
Apryse Software Corp
Radiology · 150d
Cleared Jun 25, 2026
Jabra Enhance Select Self-fit (Jabra Enhance Select 550)
K254108 · QUH
GN Hearing A/S
Ear, Nose, Throat · 188d
Cleared Jun 25, 2026
syngo.CT Coronary Cockpit
K253786 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 211d
Cleared Jun 25, 2026
Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture
K253394 · GAM
Ethicon, Inc.
General & Plastic Surgery · 268d
Cleared Jun 25, 2026
DVT Garment
K253386 · JOW
Vistar Medical Supplies Co., Ltd.
Cardiovascular · 268d
Cleared Jun 25, 2026
mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML,...
K253384 · MWJ
Seers Technology Co., Ltd.
Cardiovascular · 268d