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
2785–2808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 20, 2025
Distal Xtremities System
K252061 · HRS
TriMed, Inc.
Orthopedic · 50d
Cleared Aug 20, 2025
Salix Coronary Plaque (V1.0.0)
K251837 · QIH
Artrya Limited
Radiology · 65d
Cleared Aug 20, 2025
Methinks CTA Stroke
K251590 · QAS
Methinks Software, S.L
Radiology · 89d
Cleared Aug 20, 2025
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
K251580 · JWY
Liofilchem S. R. L.
Microbiology · 89d
Cleared Aug 20, 2025
WELLlife Flu A&B Home Test
K251563 · SCA
Wondfo USA Co., Ltd.
Microbiology · 90d
Cleared Aug 20, 2025
ACUSON Sequoia Diagnostic Ultrasound System
K251481 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 99d
Cleared Aug 20, 2025
IPD Dental Implant Abutments
K251471 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 99d
Cleared Aug 20, 2025
T2 Alpha Humerus Nailing System
K251400 · HSB
Stryker GmbH
Orthopedic · 106d
Cleared Aug 20, 2025
EndoFix™Tissue Fixation System
K251229 · FGE
Softac Medical Technologies
Gastroenterology & Urology · 121d
Cleared Aug 20, 2025
LOCATOR® Angled Abutment
K250721 · NHA
Zest Anchors, LLC
Dental · 163d
Cleared Aug 20, 2025
Remanufactured EndoWrist Cobra Grasper (420190)
K250417 · QSM
Rebotix
General & Plastic Surgery · 188d
Cleared Aug 20, 2025
Wearable Breast Pump (Model W6)
K250383 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 190d
Cleared Aug 20, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64...
K243804 · LTT
Beckman Coulter, Inc.
Microbiology · 252d
Cleared Aug 19, 2025
Venclose digiRF Generator (VCRFG1)
K252316 · GEI
Venclose, Inc.
General & Plastic Surgery · 25d
Cleared Aug 19, 2025
OSSIOfiber® Interference Screw
K252022 · MAI
OSSIO , Ltd.
Orthopedic · 50d
Cleared Aug 19, 2025
Remanufactured EndoWrist Tenaculum Forceps (420207)
K250539 · QSM
Rebotix
General & Plastic Surgery · 176d
Cleared Aug 19, 2025
Remanufactured EndoWrist Cadiere Forceps (420049)
K250399 · QSM
Rebotix
General & Plastic Surgery · 188d
Cleared Aug 19, 2025
Remanufactured EndoWrist Long Tip Forceps (420048)
K250387 · QSM
Rebotix
General & Plastic Surgery · 189d
Cleared Aug 19, 2025
Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested...
K250313 · KGO
Harps Europe Manufacturing GmbH
General Hospital · 197d
Cleared Aug 19, 2025
Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S,...
K243713 · GEI
Agnes Medical Co., Ltd.
General & Plastic Surgery · 260d
Cleared Aug 18, 2025
ANTHEM® Fracture System
K251161 · HRS
Globus Medical, Inc.
Orthopedic · 125d
Cleared Aug 18, 2025
PnueAira (PNCU-01)
K251086 · JOW
Biotab, LLC
Cardiovascular · 131d
Cleared Aug 18, 2025
Neodent Implant System - Zirconia Implant System
K250271 · DZE
JJGC Ind?stria e Com?rcio de...
Dental · 200d
Cleared Aug 18, 2025
Evolution Spine Navigation Instruments
K250167 · OLO
Evolution Spine
Orthopedic · 209d