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
2833–2856 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 12, 2017
Powder Free Nitrile Examination Gloves, Blue, Tested for Use with...
K171782 · LZA
Blue Sail Medical Co.,Ltd
General Hospital · 119d
Cleared Oct 12, 2017
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy...
K171279 · KGO
Top Glove Sdn. Bhd.
General Hospital · 164d
Cleared Oct 11, 2017
Clickfine Pen Needle, Penfine Classic Pen Needle
K171984 · FMI
Ypsomed AG
General Hospital · 103d
Cleared Oct 06, 2017
Bilicocoon™ Phototherapy System
K163526 · LBI
Neomedlight
General Hospital · 294d
Cleared Oct 04, 2017
ri-former Predictive Thermometer
K171182 · FLL
Rudolf Riester GmbH
General Hospital · 163d
Cleared Oct 03, 2017
Arisure Closed Vial Adapter
K172884 · LHI
Yukon Medical
General Hospital · 12d
Cleared Sep 29, 2017
Arisure Dry Spike
K172631 · LHI
Yukon Medical
General Hospital · 28d
Cleared Sep 29, 2017
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use...
K172420 · KGO
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 50d
Cleared Sep 29, 2017
Sherlock 3CG Tip Positioning System Stylet
K172397 · LJS
C.R. Bard, Inc.
General Hospital · 52d
Cleared Sep 29, 2017
SecurePortIV Catheter Securement Adhesive
K170505 · NZP
Adhezion Biomedical, LLC
General Hospital · 220d
Cleared Sep 28, 2017
Digital Thermometer
K170262 · FLL
K-Jump Health Co., Ltd.
General Hospital · 244d
Cleared Sep 28, 2017
SurgiCube
K163455 · ORC
Surgicube International B.V.
General Hospital · 293d
Cleared Sep 27, 2017
QiF Blood and Fluid Warmer
K171215 · LGZ
Quality IN Flow , Ltd.
General Hospital · 155d
Cleared Sep 26, 2017
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
K172015 · LZA
Careglove Global Sdn. Bhd.
General Hospital · 85d
Cleared Sep 24, 2017
Powder-free Clear Vinyl Patient Examination Gloves
K171460 · LYZ
Shandong Zhiwei Medical Products, Co....
General Hospital · 129d
Cleared Sep 22, 2017
IV Fat Emulsion Administration Sets
K172544 · FPA
Baxter Healthcare Corporation
General Hospital · 30d
Cleared Sep 22, 2017
SYSTEM 1E Liquid Chemical Sterilant Processing System
K170956 · MED
STERIS Corporation
General Hospital · 175d
Cleared Sep 20, 2017
Powder Free Nitrile Examination Gloves (Orange)
K171541 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 117d
Cleared Sep 19, 2017
Medline Blood Collection Set
K170002 · FPA
Medline Industries, Inc.
General Hospital · 259d
Cleared Sep 19, 2017
Digital Thermometer
K163518 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 278d
Cleared Sep 18, 2017
Health-e-Connect System with IDA
K163664 · NDC
Alr Technologies
General Hospital · 265d
Cleared Sep 17, 2017
BD Cathena Safety IV Catheter
K172506 · FOZ
Becton, Dickinson and Company
General Hospital · 30d
Cleared Sep 17, 2017
Endoscope Sterilization Tray
K170640 · KCT
Intuitive Surgical, Inc.
General Hospital · 199d
Cleared Sep 14, 2017
Non-Sterile, Single use, Powder-free examination glove tested for use with...
K171378 · LZA
Semperit Investments Asia Pte , Ltd.
General Hospital · 127d