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
30841–30864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 05, 2016
Verza Guidance System
K160806 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 134d
Cleared Aug 05, 2016
Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors...
K160865 · DQA
Nonin Medical, Inc.
Anesthesiology · 128d
Cleared Aug 05, 2016
QXLink
K161113 · LLZ
Vieworks Co., Ltd.
Radiology · 107d
Cleared Aug 05, 2016
LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3
K161224 · IYN
GE Medical Systems Ultrasound &...
Radiology · 98d
Cleared Aug 05, 2016
EP-TRACER System
K161245 · DQK
Cardio Tek, BV
Cardiovascular · 94d
Cleared Aug 05, 2016
SYSTEM 1E Liquid Chemical Sterilant Processing System
K161683 · MED
STERIS Corporation
General Hospital · 49d
Cleared Aug 05, 2016
Vivid iq
K161706 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 46d
Cleared Aug 05, 2016
On Call Pro Blood Glucose Monitoring System
K161867 · NBW
Acon Laboratories
Chemistry · 29d
Cleared Aug 05, 2016
Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator...
K161877 · HEB
First Quality Hygienic, Inc.
Obstetrics & Gynecology · 28d
Cleared Aug 04, 2016
CAPO BULK FILL
K152471 · EBF
Schuetz Dental GmbH
Dental · 339d
Cleared Aug 04, 2016
RENASYS TOUCH Negative Pressure Wound Therapy, RENASYS TOUCH Canisters,...
K153209 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 273d
Cleared Aug 04, 2016
Fehling-Punches
K153243 · HAE
Fehling Instruments GmbH & Co. KG
Neurology · 269d
Cleared Aug 04, 2016
Med-Tainer Single Deposit Container
K153274 · MMK
Snyder Industries, Inc.
General Hospital · 266d
Cleared Aug 04, 2016
MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis
K153329 · FIP
Med-Tech Water Systems, Inc.
Gastroenterology & Urology · 259d
Cleared Aug 04, 2016
Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators
K153540 · FRG
Safe Secure Packaging Co., Ltd.
General Hospital · 238d
Cleared Aug 04, 2016
OSSIX VOLUMAX
K153549 · NPL
Datum Dental, Ltd.
Dental · 237d
Cleared Aug 04, 2016
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators,...
K153551 · NHX
Axis-Shield Diagnostics Limited
Immunology · 237d
Cleared Aug 04, 2016
A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content...
K153744 · LYY
A1 Glove Sdn Bhd
General Hospital · 220d
Cleared Aug 04, 2016
Microlyte Ag
K153756 · FRO
Imbed Biosciences, Inc.
General & Plastic Surgery · 218d
Cleared Aug 04, 2016
OSSIX PLUS
K160281 · NPL
Datum Dental, Ltd.
Dental · 184d
Cleared Aug 04, 2016
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and...
K160560 · LZA
Hartalega Sdn Bhd
General Hospital · 157d
Cleared Aug 04, 2016
Fully Automatic Electronic Blood Pressure Monitor
K160563 · DXN
Andon Health Co, Ltd.
Cardiovascular · 157d
Cleared Aug 04, 2016
Surveyor S4 Mobile Monitor
K160685 · MHX
Mortara Instrument, Inc.
Cardiovascular · 146d
Cleared Aug 04, 2016
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling...
K161006 · LYY
Hartalega Sdn Bhd
General Hospital · 115d