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: 2026–2026 ×
1,642 results
25–48 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Jun 25, 2026
EliA CTD 13 Screen
K253367 · LLL
Phadia AB
Immunology · 268d
Cleared Jun 25, 2026
A5 Anesthesia System (A5)
K253330 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 268d
Cleared Jun 25, 2026
BedDot (G1)
K253274 · BZQ
Intelligent Dots, LLC
Anesthesiology · 269d
Cleared Jun 25, 2026
IntraOp Alignment System
K253216 · SIN
Alphatec Spine, Inc.
Radiology · 269d
Cleared Jun 25, 2026
Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B,...
K252584 · HIF
Weyo Surgical Technology , Ltd.
Obstetrics & Gynecology · 314d
Cleared Jun 25, 2026
UNIQA® Dental Implants System
K251188 · DZE
Uniqa Dental, Ltd.
Dental · 434d
Cleared Jun 24, 2026
Concerto Versa™ Detachable Coil
K261866 · KRD
Medtronic, Inc.
Cardiovascular · 20d
Cleared Jun 24, 2026
Target Xtra Detachable Coil
K261772 · HCG
Stryker Neurovscular
Neurology · 26d
Cleared Jun 24, 2026
HD Camera Head OLYMPUS CH-S200-08-LB
K261260 · FET
Olympus Medical Systems Corporation
General & Plastic Surgery · 69d
Cleared Jun 24, 2026
AMSCO 700 Steam Sterilizer
K261055 · FLE
STERIS Corporation
General Hospital · 85d
Cleared Jun 24, 2026
Microdacyn Wound Irrigation Solution
K261023 · FRO
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 86d
Cleared Jun 24, 2026
Ceribell Neurology Review Software
K260998 · OMB
Ceribell, Inc.
Neurology · 90d
Cleared Jun 24, 2026
Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)
K260937 · ITI
Shanghai Waylong Intelligent...
Physical Medicine · 96d
Cleared Jun 24, 2026
Endoform Dermal Template
K260669 · KGN
Aroa Biosurgery , Ltd.
General & Plastic Surgery · 114d
Cleared Jun 24, 2026
Hydrophilic coated intermittent nalaton catheter for single use-ready to use...
K260394 · EZD
Hangzhou Jimushi Meditech Co., Ltd.
Gastroenterology & Urology · 138d
Cleared Jun 24, 2026
Enhanced Boundary for PCCT
K253560 · JAK
Ge Medical Systems, LLC
Radiology · 219d