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
457–480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2026
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE...
K253716 · IYN
Wuhan United Imaging Healthcare Co.,Ltd
Radiology · 172d
Cleared May 15, 2026
Jada System (Jada-2002)
K253642 · OQY
Organon, LLC
Obstetrics & Gynecology · 177d
Cleared May 15, 2026
Introcan Safety® Deep Access XL IV Catheter
K253235 · FOZ
B.Braun Medical, Inc.
General Hospital · 228d
Cleared May 15, 2026
Iso-Gard Filter Straight
K252643 · CAH
Teleflex Medical Sdn. Bhd.
General Hospital · 267d
Cleared May 15, 2026
KARL STORZ Laryngoscopes and Accessories
K252624 · EQN
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 270d
Cleared May 15, 2026
Neurophet SCALE PET
K252563 · QIH
Neurophet., Inc.
Radiology · 274d
Cleared May 15, 2026
NovaLine Tubing Set for Hemodialysis (BL 124)
K252423 · FJK
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 287d
Cleared May 15, 2026
NxStage System One with NxView
K252377 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 289d
Cleared May 14, 2026
BriefCase-Triage
K261317 · QAS
Aidoc Medical , Ltd.
Radiology · 23d
Cleared May 14, 2026
TriMed Compression Screws
K261241 · HWC
TriMed, Inc.
Orthopedic · 29d
Cleared May 14, 2026
MatriDerm
K261224 · KGN
Medskin Solutions Dr. Suwelack AG
General & Plastic Surgery · 30d
Cleared May 14, 2026
Dormiva Anti-Snoring Mouth Guard
K261134 · LRK
Koncept Innovators, Inc.
Dental · 37d
Cleared May 14, 2026
Suction Pump (SU-90)
K260892 · BTA
Shenzhen HugeMed Medical Technical...
General & Plastic Surgery · 57d
Cleared May 14, 2026
SmartClip Delivery Catheter (ADR-1715)
K260565 · EOQ
Elucent Medical
Anesthesiology · 84d
Cleared May 14, 2026
Any-Etch
K260485 · KLE
Mediclus Co., Ltd.
Dental · 90d
Cleared May 14, 2026
Palmtop Ultrasound Diagnostic System (MT10P/MT10)
K260111 · IYN
Mytech Intelligence (Shenzhen) Co., Ltd.
Radiology · 120d
Cleared May 14, 2026
RAYMO Mobile X-ray System (Model: RAYMO)
K260085 · IZL
DRGEM Corporation
Radiology · 122d
Cleared May 14, 2026
ENTity USB Videoscope System
K254133 · EOB
Optim, LLC
Ear, Nose, Throat · 143d
Cleared May 14, 2026
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M,...
K254048 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 148d
Cleared May 14, 2026
SubtleHD-PET (1.x)
K254013 · LLZ
Subtle Medical, Inc.
Radiology · 150d
Cleared May 14, 2026
Bonalive Maxillofacial
K253883 · LYC
Bonalive , Ltd.
Dental · 161d
Cleared May 14, 2026
CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)
K253676 · MRW
Providence Medical Technology, Inc.
Orthopedic · 174d
Cleared May 14, 2026
ET Healing Abutments
K253372 · NHA
Hiossen, Inc.
Dental · 226d
Cleared May 14, 2026
ART.1-US
K253078 · MUJ
Seetreat Pty, Ltd.
Radiology · 233d