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
433–456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 2026
Taperloc® Complete Hip Stem
K251270 · LPH
Biomet, Inc.
Orthopedic · 390d
Cleared May 18, 2026
RhinAer+ Stylus
K260522 · GEI
Aerin Medical, Inc.
Ear, Nose, Throat · 90d
Cleared May 18, 2026
MOSES Raydar™
K260100 · GEX
Boston Scientific Corporation
Gastroenterology & Urology · 125d
Cleared May 18, 2026
G-CEM UNIVERSAL
K254109 · EMA
GC America, Inc.
Dental · 150d
Cleared May 18, 2026
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
K253831 · LLZ
Cercare Medical A/S
Radiology · 168d
Cleared May 18, 2026
HALYARD* ONE-STEP* Sterilization Wrap
K253454 · FRG
O&M Halyard, Inc.
General Hospital · 227d
Cleared May 18, 2026
Coude Sleeved IC
K253295 · EZD
Hollister Incorporated
Gastroenterology & Urology · 231d
Cleared May 18, 2026
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
K252047 · NEW
Ethicon, Inc.
General & Plastic Surgery · 322d
Cleared May 16, 2026
BluEX Cervical Expandable Cage System
K260840 · ODP
L & K Biomed Co., Ltd.
Orthopedic · 61d
Cleared May 15, 2026
UNiD™ Spine Analyzer (SW3002)
K261289 · QIH
Medicrea International S.A.S....
Radiology · 25d
Cleared May 15, 2026
Neurophet AQUA
K261273 · QIH
Neurophet., Inc.
Radiology · 28d
Cleared May 15, 2026
Stellaris Elite™ vision enhancement system
K261264 · HQC
Bausch and Lomb
Ophthalmic · 29d
Cleared May 15, 2026
Varion Thoracolumbar Fixation System
K260989 · NKB
Kyocera Medical Technologies Inc. (KMTI)
Orthopedic · 51d
Cleared May 15, 2026
TruSelect™ 2.6 Microcatheter
K260771 · KRA
Boston Scientific Corporation
Cardiovascular · 67d
Cleared May 15, 2026
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
K260536 · KWL
Depuy Ireland UC
Orthopedic · 87d
Cleared May 15, 2026
Ventana® P/T Lumbar Interbody System
K260506 · MAX
Spinal Elements, Inc.
Orthopedic · 87d
Cleared May 15, 2026
Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02
K260134 · BTA
Shenzhen Root Innovation Technology...
Ear, Nose, Throat · 119d
Cleared May 15, 2026
NOVEOS Specific IgE (sIgE)
K260059 · DHB
Hycor Biomedical
Immunology · 127d
Cleared May 15, 2026
SubtleHD-CT (1.x)
K254120 · QIH
Subtle Medical, Inc.
Radiology · 147d
Cleared May 15, 2026
Manual Tissue Removal Device
K254050 · HIH
Suzhou AcuVu Medical Technology Co.,...
Obstetrics & Gynecology · 149d
Cleared May 15, 2026
Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior,...
K254028 · IYN
Sonoscape Medical Corp.
Radiology · 150d
Cleared May 15, 2026
medXion NEXUS
K253935 · OAS
medXion Technologies, Inc.
Radiology · 157d
Cleared May 15, 2026
cobas liat CT/NG/MG nucleic acid test
K253759 · QEP
Roche Molecular Systems, Inc.
Microbiology · 171d
Cleared May 15, 2026
cobas liat CT/NG nucleic acid test
K253756 · QEP
Roche Molecular Systems, Inc.
Microbiology · 171d