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: Cleared only ×
175,230 results
8905–8928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2023
EConsole1
K231225 · LLZ
DRTECH Corporation
Radiology · 173d
Cleared Oct 18, 2023
Terumo Injection Filter Needle (NF-3013RBKE05M)
K230951 · QYM
Terumo Europe N.V.
General Hospital · 197d
Cleared Oct 18, 2023
Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
K230702 · CAW
Qingdao Kingon Medical Science and...
Anesthesiology · 218d
Cleared Oct 18, 2023
Byte Aligner System
K230199 · NXC
Dentsply Sirona, Inc.
Dental · 266d
Cleared Oct 17, 2023
Legend X Platform
K232903 · GEI
Pollogen, Ltd.
General & Plastic Surgery · 29d
Cleared Oct 17, 2023
TransLoc 3D
K232878 · OUR
Foundation Fusion Solutions, LLC (Dba...
Orthopedic · 29d
Cleared Oct 17, 2023
Dynamic TiBase
K232151 · NHA
Talladium Espa?a, SL
Dental · 90d
Cleared Oct 17, 2023
SOZO Pro
K232089 · DSB
ImpediMed Limited
Gastroenterology & Urology · 96d
Cleared Oct 17, 2023
HAtetracell™-C Titanium Cervical IBF System
K231899 · ODP
Innovasis, Inc.
Orthopedic · 111d
Cleared Oct 17, 2023
Infinity CentralStation Wide, Infinity M300, Infinity M300+
K231477 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 148d
Cleared Oct 17, 2023
Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)
K231105 · FBN
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 181d
Cleared Oct 17, 2023
Lumen 155-SF
K223911 · QDD
Intricon Corporation
Ear, Nose, Throat · 292d
Cleared Oct 17, 2023
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
K222214 · FXY
Thi Total Healthcare Innovation GmbH
General Hospital · 449d
Cleared Oct 16, 2023
ANDORATE® Valve Kit
K232118 · ODC
Ga Health Company Limited
Gastroenterology & Urology · 91d
Cleared Oct 16, 2023
Iontophoresis Electrodes
K232020 · EGJ
Top-Rank Health Care Co., Ltd.
Physical Medicine · 101d
Cleared Oct 16, 2023
Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)
K231725 · GCJ
Hunan Endoso Life Technology Co., Ltd.
General & Plastic Surgery · 125d
Cleared Oct 16, 2023
Willow Generation 3 Breast Pump
K230570 · HGX
Willow Innovations, Inc.
Obstetrics & Gynecology · 229d
Cleared Oct 16, 2023
Ikshana
K230249 · LLZ
Immersivetouch
Radiology · 259d
Cleared Oct 16, 2023
Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
K230104 · DZE
Anthogyr
Dental · 276d
Cleared Oct 14, 2023
Infrared Thermometer (AOJ-20A)
K232128 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 89d
Cleared Oct 13, 2023
Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system),...
K232822 · ODP
Gbs Commonwealth Co., Ltd.
Orthopedic · 30d
Cleared Oct 13, 2023
Calibrate CCX Interbody System
K232504 · MAX
Alphatec Spine, Inc.
Orthopedic · 56d
Cleared Oct 13, 2023
RIGEL™ 3DR Anterior Cervical Corpectomy System
K232481 · PLR
MiRus, LLC
Orthopedic · 58d
Cleared Oct 13, 2023
Paragon 8F Balloon Guide Catheter
K232437 · DQY
Wallaby Medical
Neurology · 60d