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
5929–5952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 2024
VersaTap™ Suture Anchor (ADP050)
K242296 · MBI
Ortho-Design (Pty), Ltd.
Orthopedic · 27d
Cleared Aug 29, 2024
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal...
K242280 · MQV
Stryker Spine
Orthopedic · 27d
Cleared Aug 29, 2024
Target Detachable Coils
K242243 · HCG
Stryker Neurovscular
Neurology · 29d
Cleared Aug 29, 2024
IPL Hair Removal Device (JM-843, JM-865, JM-638)
K241881 · OHT
Shenzhen Junmei Technology Co., Ltd.
General & Plastic Surgery · 62d
Cleared Aug 29, 2024
SkinPen Precision Elite System
K241400 · QAI
Crown Aesthetics
General & Plastic Surgery · 104d
Cleared Aug 29, 2024
RHYTHMIA HDx™ Mapping System
K241227 · DQK
Boston Scientific Corporation
Cardiovascular · 119d
Cleared Aug 29, 2024
Navigator (FMNVG15)
K240105 · ITI
Forcemech International, LLC
Physical Medicine · 226d
Cleared Aug 29, 2024
Kosmos
K233826 · IYN
EchoNous, Inc.
Radiology · 272d
Cleared Aug 29, 2024
Ensol EnTM Specimen Collection and Transport System
K220908 · JSM
Ensol Biosciences, Inc.
Microbiology · 884d
Cleared Aug 28, 2024
Safety Lancet
K242316 · FMK
Ningbo Medsun Medical Co., Ltd.
General & Plastic Surgery · 23d
Cleared Aug 28, 2024
Mojo Full Face Non-Vented Mask
K241943 · CBK
Sleepnet Corporation
Anesthesiology · 57d
Cleared Aug 28, 2024
OSSIOfiber® Compression Staple
K241932 · MNU
OSSIO , Ltd.
Orthopedic · 58d
Cleared Aug 28, 2024
da Vinci Handheld Camera
K241913 · GCJ
Intuitive Surgical Operations, Inc.
General & Plastic Surgery · 58d
Cleared Aug 28, 2024
Cercon® yo ML
K241557 · EIH
Dentsply Sirona
Dental · 89d
Cleared Aug 28, 2024
VITROS Immunodiagnostic Products Syphilis Reagent Pack
K241534 · LIP
Ortho-Clinical Diagnostics
Microbiology · 90d
Cleared Aug 28, 2024
Vista BC Putty
K241457 · KIF
Inter-Med, Inc.
Dental · 97d
Cleared Aug 28, 2024
GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with...
K240545 · LZA
Genabio Diagnostics, Inc.
General Hospital · 183d
Cleared Aug 28, 2024
Fogarty Thru-Lumen Embolectomy Catheter
K240078 · DXE
Edwards Lifesciences, LLC
Cardiovascular · 230d
Cleared Aug 28, 2024
OxiWear
K233827 · DQA
Oxiwear, Inc.
Anesthesiology · 271d
Cleared Aug 28, 2024
REDEMPTION Charcot Plating System
K233816 · HRS
Vilex, LLC
Orthopedic · 272d
Cleared Aug 28, 2024
BT-1000
K232991 · QGL
Bistos Co., Ltd.
Neurology · 341d
Cleared Aug 27, 2024
BracePaste Fluoride Sealant
K242537 · DYH
American Orthodontics Corp.
Dental · 1d
Cleared Aug 27, 2024
Disposable Syringe (Kit)
K242212 · DXT
Nemoto Kyorindo Co., Ltd.
General Hospital · 29d
Cleared Aug 27, 2024
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K241787 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 67d