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
793–816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2026
Pressio 3 Multi-parameter Neuromonitoring System
K252241 · GWM
Sophysa
Neurology · 267d
Cleared Apr 10, 2026
ABL90 FLEX PLUS System, safeCLINITUBES
K252207 · CHL
Radiometer Medicals Aps
Chemistry · 270d
Cleared Apr 10, 2026
DeepBT Detector-Plus
K252190 · QKB
Aitewan Biomedical Technology, Inc.
Radiology · 270d
Cleared Apr 09, 2026
LOCATOR® Angled Abutment
K260555 · NHA
Zest Anchors, LLC
Dental · 50d
Cleared Apr 09, 2026
RCT800
K260462 · OAS
Ray Co., Ltd.
Radiology · 56d
Cleared Apr 09, 2026
Artelon Convenience Kits
K260317 · QWJ
International Life Sciences
Orthopedic · 69d
Cleared Apr 09, 2026
SILKBridge
K260245 · JXI
KLISBio S.r.l.
Neurology · 72d
Cleared Apr 09, 2026
Eternal Art Porcelain Powders
K260067 · EIH
Shandong Huge Dental Material...
Dental · 90d
Cleared Apr 09, 2026
Picosecond Nd:YAG Laser Systems (Model: HS-298)
K260017 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 94d
Cleared Apr 09, 2026
SPINEART Navigation Instrument System
K254158 · OLO
Spineart SA
Orthopedic · 108d
Cleared Apr 09, 2026
Accuro XV
K254021 · IYO
Rivanna Medical, Inc.
Radiology · 114d
Cleared Apr 09, 2026
Radical 6F Access Catheter
K253975 · QJP
Maduro Medical, Inc.
Neurology · 119d
Cleared Apr 09, 2026
Single Use Digital Flexible Ureteroscope (7.5F)
K252929 · FGB
Anhui Happiness Workshop Instruments...
Gastroenterology & Urology · 206d
Cleared Apr 09, 2026
EASYMADE-TI
K252251 · GXN
CG Bio Co., Ltd.
Neurology · 265d
Cleared Apr 09, 2026
Seaman Pro/Seaman
K252228 · POV
Checkcells, Inc.
Hematology · 267d
Cleared Apr 08, 2026
OptiCross Coronary Imaging Catheter (H749518110)
K260816 · OBJ
Boston Scientific
Cardiovascular · 26d
Cleared Apr 08, 2026
Celerity 5 HP Biological Indicator (LCB052)
K260766 · FRC
STERIS Corporation
General Hospital · 30d
Cleared Apr 08, 2026
CATAMARAN™ SI Joint Fusion System
K260477 · OUR
Tenon Medical
Orthopedic · 55d
Cleared Apr 08, 2026
LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
K260420 · EOQ
MacroLux Medical Technology Co., Ltd.
Ear, Nose, Throat · 58d
Cleared Apr 08, 2026
Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)
K260197 · GCJ
Suzhou Shenyun Medical Equipment Co.,...
General & Plastic Surgery · 76d
Cleared Apr 08, 2026
TL-10 Laparoscopic Scope Cleaner
K260089 · GCJ
Scopix , Ltd.
General & Plastic Surgery · 86d
Cleared Apr 08, 2026
Wearable Breast Pump (Model S21A)
K260033 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 92d
Cleared Apr 08, 2026
Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D,...
K254258 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 100d
Cleared Apr 08, 2026
Pivot Insulin Delivery System
K253534 · LZG
Modular Medical
Chemistry · 146d