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
3073–3096 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 22, 2016
WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
K162225 · MRZ
Welldoc, Inc.
General Hospital · 106d
Cleared Nov 22, 2016
Disposable High Pressure Injector Syringe
K152906 · DXT
Wuxi Yushou Medical Appliances Co., Ltd.
General Hospital · 418d
Cleared Nov 21, 2016
Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2...
K162175 · LYY
Vietglove Corporation
General Hospital · 110d
Cleared Nov 21, 2016
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and...
K161944 · LZA
Shandong Baisheng Medical Products...
General Hospital · 129d
Cleared Nov 18, 2016
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical...
K160595 · FRG
Pms Medikal Ambalaj Sanayi VE Ticaret...
General Hospital · 262d
Cleared Nov 17, 2016
Non-contact Forehead Thermometer
K161735 · FLL
Shenzhen Dongdixin Technology Co., Ltd.
General Hospital · 147d
Cleared Nov 17, 2016
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
K161074 · LZA
Shen Wei (Usa), Inc.
General Hospital · 213d
Cleared Nov 15, 2016
AccuCath Intravascular Catheter
K162894 · FOZ
C.R. Bard, Inc.
General Hospital · 29d
Cleared Nov 15, 2016
Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)
K153409 · FXX
Protect U Guard, LLC
General Hospital · 356d
Cleared Nov 09, 2016
Insulia Diabetes Management Companion
K161433 · NDC
Voluntis Sa.
General Hospital · 169d
Cleared Nov 07, 2016
Powder Free Nitrile Examination Gloves (Blue)
K162113 · LZA
Nam Viet Glove Joint Stock Company
General Hospital · 101d
Cleared Nov 04, 2016
Barrier Supreme Sterilization Wrapper
K162162 · FRG
Standard Textile Co., Inc.
General Hospital · 94d
Cleared Nov 04, 2016
PRIMAGARD Isolation Gown (AAMI PB70 Level 3)
K160361 · FYC
Primed Medical Products, Inc.
General Hospital · 269d
Cleared Nov 03, 2016
MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV...
K161779 · FOZ
Medsource International, LLC
General Hospital · 127d
Cleared Nov 03, 2016
CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS...
K160921 · PSW
Cs Medical, LLC
General Hospital · 213d
Cleared Nov 03, 2016
Greiner Holdex
K160532 · FMI
Greiner Bio-One Na, Inc.
General Hospital · 251d
Cleared Nov 02, 2016
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with...
K162095 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 97d
Cleared Oct 28, 2016
Gammex Cut-Resistant Glove Liner
K160974 · KGO
Ansell Healthcare Products, LLC
General Hospital · 204d
Cleared Oct 25, 2016
PowerPICC Provena Catheters
K162443 · LJS
C.R. Bard, Inc.
General Hospital · 55d
Cleared Oct 25, 2016
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device...
K162080 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 90d
Cleared Oct 20, 2016
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE,...
K161422 · LZA
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 150d
Cleared Oct 19, 2016
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with...
K161473 · LZA
Medline Industries, Inc.
General Hospital · 145d
Cleared Oct 19, 2016
Advocate Insulin Pen Needles
K160199 · FMI
Diabetic Supply of Suncoast, Inc.
General Hospital · 265d
Cleared Oct 18, 2016
NovoPen Echo
K162602 · FMF
Novo Nordisk, Inc.
General Hospital · 29d