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
12001–12024 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 04, 2022
Humerus & Ulna System
K213108 · HRS
Auxein Medical Private Limited
Orthopedic · 406d
Cleared Nov 04, 2022
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring...
K220421 · NBW
Apex BioTechnology Corp.
Chemistry · 263d
Cleared Nov 04, 2022
Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and...
K220833 · MAI
Acuitive Technologies, Inc.
Orthopedic · 227d
Cleared Nov 04, 2022
cobas HCV
K221007 · MZP
Roche Molecular Systems, Inc.
Microbiology · 213d
Cleared Nov 04, 2022
CryoRobot Select System
K221086 · QUJ
Tmrw Life Sciences, Inc.
Obstetrics & Gynecology · 205d
Cleared Nov 04, 2022
UniVy OsteoVy Cervical IBF System
K221162 · ODP
Vy Spine, LLC
Orthopedic · 196d
Cleared Nov 04, 2022
Nextra CH Cannulated Hammertoe System
K221610 · HWC
Nextremity Solutions, Inc.
Orthopedic · 154d
Cleared Nov 04, 2022
Luminopia One
K221659 · QQU
Luminopia, Inc.
Ophthalmic · 149d
Cleared Nov 04, 2022
United U2 femoral head, 22mm delta ceramic head
K221675 · LPH
United Orthopedic Corporation
Orthopedic · 148d
Cleared Nov 04, 2022
BENCHMARK BMX81 Access System
K221822 · QJP
Penumbra, Inc.
Neurology · 134d
Cleared Nov 04, 2022
Yomi Robotic System
K222049 · QRY
Neocis, Inc.
Dental · 115d
Cleared Nov 04, 2022
Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle
K222124 · FMI
Anhui Hongyu Wuzhou Medical...
General Hospital · 109d
Cleared Nov 04, 2022
Self-adhesive Electrode
K222453 · GXY
Guangdong Comytens Medical Technology...
Neurology · 81d
Cleared Nov 04, 2022
VHA Radiotherapy Bolus
K222639 · IXI
Vha Dean
Radiology · 64d
Cleared Nov 04, 2022
Disposable Medical Face Mask (DF3-001)
K222697 · FXX
Wellmed Dental Medical Supply Co., Ltd.
General Hospital · 58d
Cleared Nov 04, 2022
World Total Knee System
K223062 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 35d
Cleared Nov 04, 2022
Aquilo Sports CCT1500 System
K223164 · IRP
Aquilo Sports, LLC
Neurology · 28d
Cleared Nov 03, 2022
Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes,...
K220263 · HQB
Vortex Surgical, Inc.
Ophthalmic · 276d
Cleared Nov 03, 2022
ibiomedi Electronic Stethoscope ES-2020
K220466 · DQD
Sound Land Corp.
Cardiovascular · 259d
Cleared Nov 03, 2022
Insulin Syringes without needle
K221045 · FMF
Berpu Medical Technology Co., Ltd.
General Hospital · 209d
Cleared Nov 03, 2022
NP Medical nCompass Extension Set with Stabilizing Base
K221518 · FPA
Np Medical
General Hospital · 162d
Cleared Nov 03, 2022
ABTross ALIF Expandable Cage System
K221719 · MAX
Aegis Spine, Inc.
Orthopedic · 143d
Cleared Nov 03, 2022
Black Diamond™ POCT Spinal System
K222107 · NKG
Osseus Fusion Systems
Orthopedic · 108d
Cleared Nov 03, 2022
Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie...
K222168 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 105d