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
27193–27216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 2017
585
K172198 · GEX
Quanta System Spa
General & Plastic Surgery · 88d
Cleared Oct 17, 2017
EnsoETM
K172493 · PLA
Attune Medical
Cardiovascular · 60d
Cleared Oct 17, 2017
Applanation tonometer AT-1
K172728 · HKY
Takagi Seiko Co., Ltd.
Ophthalmic · 36d
Cleared Oct 17, 2017
Bencox Mirabo Cup System
K172806 · LPH
Corentec Co., Ltd.
Orthopedic · 29d
Cleared Oct 17, 2017
4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS...
K172817 · FET
Olympus Medical Systems Corp.
Gastroenterology & Urology · 29d
Cleared Oct 16, 2017
OptiScanner 5000 Glucose Monitoring System
K162042 · LZF
Optiscan Biomedical Corp.
Chemistry · 448d
Cleared Oct 16, 2017
AcQMap 3D Imaging and Mapping Catheter
K170819 · MTD
Acutus Medical, Inc.
Cardiovascular · 210d
Cleared Oct 16, 2017
AcQMap High Resolution Imaging and Mapping System
K170948 · DQK
Acutus Medical, Inc.
Cardiovascular · 200d
Cleared Oct 16, 2017
HylaGuard Moisturizing Cream
K171879 · MGQ
Founders Science Group, LLC
General & Plastic Surgery · 115d
Cleared Oct 16, 2017
Solana RSV+hMPV Assay
K171974 · OCC
Quidel Corporation
Microbiology · 108d
Cleared Oct 16, 2017
BioWick X Implant with Driver
K172186 · MBI
Cayenne Medical, Inc.
Orthopedic · 88d
Cleared Oct 16, 2017
Coaxial Dilator Set (Micro-Introducer)
K172487 · DRE
Galt Medical Corp.
Cardiovascular · 60d
Cleared Oct 16, 2017
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage...
K172537 · JXG
Codman & Shurtleff, Inc.
Neurology · 55d
Cleared Oct 13, 2017
PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator
K162362 · FRG
Pms Tibbi Cihazlar Teknolojisi San VE...
General Hospital · 416d
Cleared Oct 13, 2017
SuperNO2VA Device
K163277 · BSJ
Revolutionary Medical Devices, Inc.
Anesthesiology · 326d
Cleared Oct 13, 2017
NOVOS-NAIL Limb Lengthening System (LLS)
K163653 · HSB
Smith & Nephew
Orthopedic · 294d
Cleared Oct 13, 2017
SleepImage System
K163696 · MNR
Mycardio, LLC Dba Sleepimage.
Anesthesiology · 288d
Cleared Oct 13, 2017
Electronic Blood Pressure Monitor
K170151 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 269d
Cleared Oct 13, 2017
AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer
K170232 · JLW
Boditech Med, Inc.
Chemistry · 261d
Cleared Oct 13, 2017
Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter,...
K170233 · EZD
Zhanjiang Star Enterprise Co., Ltd.
Gastroenterology & Urology · 261d
Cleared Oct 13, 2017
GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose...
K170241 · NBW
All Medicus Co., Ltd.
Chemistry · 260d
Cleared Oct 13, 2017
Citryte
K171015 · KPO
Di-Chem, Inc.
Gastroenterology & Urology · 192d
Cleared Oct 13, 2017
Senhance Surgical Robotic System
K171120 · NAY
Transenterix, Inc.
General & Plastic Surgery · 182d
Cleared Oct 13, 2017
PAL Multi-Use Cannulas and PAL Manual Wand
K171286 · QPB
Microaire Surgical Instruments, LLC
General & Plastic Surgery · 165d