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
3505–3528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 03, 2025
RZ Resectoscope System
K243382 · HIH
Rz Medizintechnik GmbH
Obstetrics & Gynecology · 215d
Cleared Jun 03, 2025
EVAC
K243205 · JXG
Phasor Health, LLC
Neurology · 245d
Cleared Jun 03, 2025
Partial Flex
K242897 · EBI
Clemde SA DE CV
Dental · 253d
Cleared Jun 02, 2025
Tera Lumbar Interbody Fusion System (Various PNs)
K251335 · MAX
Acuity Surgical Devices, LLC
Orthopedic · 33d
Cleared Jun 02, 2025
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
K250965 · JPA
Sysmex America, Inc.
Hematology · 63d
Cleared Jun 02, 2025
PULLUP®
K250844 · MBI
Science & Bio Materials (S.B.M.) Sas
Orthopedic · 74d
Cleared Jun 02, 2025
CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B,...
K250452 · FED
MacroLux Medical Technology Co., Ltd.
Gastroenterology & Urology · 104d
Cleared Jun 02, 2025
GORE® Tri-Lobe Balloon Catheter
K250410 · DQY
W.L. Gore & Associates, Inc.
Cardiovascular · 109d
Cleared May 31, 2025
LimFlow ARC
K251376 · PDU
LimFlow, Inc.
Cardiovascular · 29d
Cleared May 30, 2025
BriefCase-Triage
K251406 · QAS
Aidoc Medical , Ltd.
Radiology · 24d
Cleared May 30, 2025
Prestige Coil System (Prestige Packing Line Extension)
K251383 · KRD
Balt USA, LLC
Cardiovascular · 28d
Cleared May 30, 2025
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000)
K251238 · GEI
Maquet Cardiovascular, LLC
General & Plastic Surgery · 38d
Cleared May 30, 2025
TekBrace Solo Soft Tissue Reinforcement Device
K251063 · QUW
Theramicro
Orthopedic · 56d
Cleared May 30, 2025
Disposable Biopsy Forceps (FB-211D)
K250957 · EOQ
Olympus Medical Systems Corporation
Anesthesiology · 60d
Cleared May 30, 2025
VCFix Spinal System
K250637 · NDN
Amber Implants
Orthopedic · 88d
Cleared May 30, 2025
KALA Red Light Face Mask (KALA-01)
K250581 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 92d
Cleared May 30, 2025
Wearable Breast Pump (Model S21)
K250368 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 109d
Cleared May 30, 2025
Motif Aura Glow breast pump (Model Motif Aura Glow)
K250365 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 109d
Cleared May 30, 2025
EsFlow PLUS
K250317 · EBF
Spident Co., Ltd.
Dental · 115d
Cleared May 30, 2025
Swoop® Portable MR Imaging® System (V2)
K250236 · LNH
Hyperfine, Inc.
Radiology · 123d
Cleared May 30, 2025
MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
K250195 · GEX
Matelaser, Inc.
General & Plastic Surgery · 127d
Cleared May 30, 2025
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set)
K250150 · DTR
Sorin Group Italia S.R.L.
Cardiovascular · 129d
Cleared May 30, 2025
Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
K250078 · QME
Mindset Medical, Inc.
Cardiovascular · 137d
Cleared May 30, 2025
TE Air Diagnostic Ultrasound System
K250024 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 144d