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
2905–2928 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 19, 2017
Graftgun Universal Graft Delivery System
K170675 · FMF
SurGenTec, LLC
General Hospital · 135d
Cleared Jul 18, 2017
20G x 5/8 Pro-Lock CT Safety Infusion Set
K171333 · PTI
Medcomp (Dba Medical Components, Inc.)
General Hospital · 71d
Cleared Jul 18, 2017
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
K162510 · LZA
Ug Global Resources Sdn. Bhd.
General Hospital · 313d
Cleared Jul 14, 2017
Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with...
K170686 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 129d
Cleared Jul 13, 2017
SterilContainer S System
K162815 · KCT
Aesculap, Inc.
General Hospital · 280d
Cleared Jul 10, 2017
Mini Needle
K170768 · FMI
Ocuject, LLC
General Hospital · 118d
Cleared Jul 10, 2017
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile,...
K170397 · LZA
Kossan International Sdn Bhd
General Hospital · 151d
Cleared Jul 07, 2017
EMG Blue Nitrile Examination Gloves Powder free with tested for use with...
K171339 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 60d
Cleared Jul 07, 2017
DilaCheck Nitrile Powder Free Examination Glove, (Sterile)
K163035 · LZA
Elm Tree Medical, Inc.
General Hospital · 249d
Cleared Jul 07, 2017
Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
K160337 · QPC
Bam Corporation Limited
General Hospital · 515d
Cleared Jul 03, 2017
Equashield Closed System drug Transfer Device (CSTD)
K170706 · ONB
Equashield Medical , Ltd.
General Hospital · 117d
Cleared Jun 30, 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K170794 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 106d
Cleared Jun 29, 2017
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
K171533 · FRG
Ahlstrom Nonwovens, LLC
General Hospital · 35d
Cleared Jun 27, 2017
Powder-Free Clear Vinyl Patient Examination Gloves
K170735 · LYZ
Zibo Yue Fan Medical Products Co, Ltd.
General Hospital · 109d
Cleared Jun 23, 2017
POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED
K170094 · LYY
Vietglove Corporation
General Hospital · 163d
Cleared Jun 23, 2017
hypodermic Pinpoint™ GT Needle
K163437 · PVZ
C.R. Bard, Inc.
General Hospital · 198d
Cleared Jun 23, 2017
Gemini Sterilization Wrap
K162993 · FRG
Medline Industries, Inc.
General Hospital · 239d
Cleared Jun 23, 2017
Babyleo TN500
K162821 · FMZ
Draegerwerk AG & CO Kgaa
General Hospital · 259d
Cleared Jun 22, 2017
Sterile Polyisoprene Powder Free Surgical Gloves
K171047 · KGO
Better Care Plastic Technology Co., Ltd.
General Hospital · 76d
Cleared Jun 21, 2017
Solution Set with 1.2 Micron Air Eliminating Filter
K161808 · FPA
Baxter Healthcare Corporation
General Hospital · 355d
Cleared Jun 20, 2017
STERRAD VELOCITY Biological Indictator and Reader
K170039 · FRC
Advanced Sterilization Products (Asp)
General Hospital · 166d
Cleared Jun 19, 2017
Insulia Diabetes Management Companion
K170669 · NDC
Voluntis Sa.
General Hospital · 105d
Cleared Jun 15, 2017
Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves,...
K170198 · KGO
Cardinal Health, Inc.
General Hospital · 143d
Cleared Jun 15, 2017
Encore Neutral
K162826 · FPA
Rymed Technologies, LLC
General Hospital · 251d