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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
3121–3144 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 29, 2016
BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems
K161777 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 61d
Cleared Aug 29, 2016
Digital Thermometer
K161211 · FLL
Biocare Asia Corporation , Ltd.
General Hospital · 123d
Cleared Aug 29, 2016
Insulin Pen Needle
K153706 · FMI
SteriLance Medical (Suzhou), Inc.
General Hospital · 250d
Cleared Aug 26, 2016
Skypro, SP01 Mask
K152197 · FXX
Skypro Medical Supplies Company
General Hospital · 387d
Cleared Aug 25, 2016
LifeFlow Rapid Infusion Device (LifeFlow Device)
K153731 · FPA
410 Medical Innovation, LLC
General Hospital · 241d
Cleared Aug 24, 2016
ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and...
K161313 · PND
Arrow International, Inc. (Subsidiary...
General Hospital · 106d
Cleared Aug 24, 2016
Infrared Forehead Thermometer, FT-100A
K160802 · FLL
Hangzhou Universal Electronic Co., Ltd.
General Hospital · 154d
Cleared Aug 19, 2016
0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle
K162030 · MEG
Sol-Millennium Medical, Inc.
General Hospital · 28d
Cleared Aug 18, 2016
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
K153440 · FPA
C.R. Bard, Inc.
General Hospital · 265d
Cleared Aug 16, 2016
The Braun ThermoScan® 3 High Speed Compact Ear Thermometer
K161933 · FLL
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 33d
Cleared Aug 12, 2016
SUPERCATH 6
K160592 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 164d
Cleared Aug 10, 2016
MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
K160648 · FPA
Unomedical A/S
General Hospital · 156d
Cleared Aug 05, 2016
SYSTEM 1E Liquid Chemical Sterilant Processing System
K161683 · MED
STERIS Corporation
General Hospital · 49d
Cleared Aug 04, 2016
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling...
K161006 · LYY
Hartalega Sdn Bhd
General Hospital · 115d
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
A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content...
K153744 · LYY
A1 Glove Sdn Bhd
General Hospital · 220d
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
Med-Tainer Single Deposit Container
K153274 · MMK
Snyder Industries, Inc.
General Hospital · 266d
Cleared Aug 03, 2016
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile,...
K151750 · LZA
Kossan International Sdn Bhd
General Hospital · 401d
Cleared Aug 02, 2016
Powder free vinyl patient examination glove, colored (yellow)
K160675 · LYZ
Kaixing Plastic Products Co., Litd.
General Hospital · 145d
Cleared Aug 02, 2016
Sterile Powder Free Nitrile Examination Gloves, Blue Colored. Tested For Use...
K160467 · LZA
Kossan International Sdn Bhd
General Hospital · 165d
Cleared Aug 02, 2016
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low...
K151824 · LZA
Kossan International Sdn Bhd
General Hospital · 393d
Cleared Aug 01, 2016
Infra-red forehead thermometer
K160999 · FLL
Hangzhou Hua'An Medical&Health...
General Hospital · 112d
Cleared Jul 29, 2016
Powder Free Blue Nitrile Examination Glove
K153732 · LZA
Qube Medical Product Sdn Bhd
General Hospital · 214d