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
3481–3504 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 09, 2015
ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE
K140949 · MEG
Ultimed Incorporated
General Hospital · 301d
Cleared Feb 05, 2015
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE,...
K141982 · LZC
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 199d
Cleared Jan 27, 2015
Celerity PICC Tip Confirmation System
K142889 · LJS
AngioDynamics, Inc.
General Hospital · 116d
Cleared Jan 27, 2015
NAUTILUS DELTA
K141634 · LJS
Romedex International Srl
General Hospital · 223d
Cleared Jan 23, 2015
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
K141448 · ONB
Teva Medical Ltd., Migada Plant
General Hospital · 235d
Cleared Jan 22, 2015
Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White...
K143247 · LZA
Central Medicare Sdn Bhd
General Hospital · 71d
Cleared Jan 20, 2015
STERILUCENT STERILIZATION CONTAINER SYSTEM
K142109 · KCT
Sterilucent, Inc.
General Hospital · 169d
Cleared Jan 20, 2015
STERISAFE HP TABLE-TOP STEAM STERILIZER
K140736 · FLE
Milton E Pedrazzi D.D.S., Inc.
General Hospital · 302d
Cleared Jan 16, 2015
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).
K142862 · LZA
Careplus (M) Sdn Bhd
General Hospital · 107d
Cleared Jan 16, 2015
All Safe Huber Safety Infusion Set
K142590 · FPA
Nexus Medical, LLC
General Hospital · 123d
Cleared Jan 16, 2015
Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White...
K142283 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 154d
Cleared Jan 16, 2015
PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0...
K141789 · FRN
Hospira, Inc.
General Hospital · 198d
Cleared Jan 15, 2015
Pre-vacuum Tabletop Autoclave
K143311 · FLE
Tuttnauer U.S.A Co, Ltd.
General Hospital · 58d
Cleared Jan 15, 2015
Powder-free PVC Vinyl Exam Gloves
K142703 · LYZ
Hebei Grandeast Plastic Products Co.,...
General Hospital · 115d
Cleared Jan 15, 2015
IV Administration
K142622 · FPA
Hospira, Inc.
General Hospital · 121d
Cleared Jan 15, 2015
JIUYUAN POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
K141224 · LYZ
Shijiazhunag Jiuyuan Plastic Co., Ltd.
General Hospital · 248d
Cleared Jan 14, 2015
RapidVac Smoke Evacuator System
K142335 · FYD
Covidien
General Hospital · 146d
Cleared Jan 09, 2015
t:flex Insulin Delivery System
K143189 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 65d
Cleared Jan 09, 2015
Extension Sets
K142974 · FPA
Hospira, Inc.
General Hospital · 87d
Cleared Jan 08, 2015
ANUTRA Feedback Aspiration Syringe
K143757 · FMF
Anutra Medical, Inc.
General Hospital · 8d
Cleared Jan 08, 2015
Genesis Reusable Rigid Container System
K142529 · KCT
Carefusion 2200, Inc.
General Hospital · 121d
Cleared Jan 08, 2015
ACCUCATH MIDLINE CATHETER SYSTEM
K142136 · FOZ
Vascular Pathways, Inc.
General Hospital · 157d
Cleared Jan 08, 2015
3M STERI-VAC STERILIZER/AERATOR
K142034 · FLF
3M Company
General Hospital · 164d
Cleared Dec 30, 2014
NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
K142173 · LHC
Ecolab, Inc.
General Hospital · 145d