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
3313–3336 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 20, 2015
Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters
K150514 · LJT
C.R. Bard, Inc.
General Hospital · 266d
Cleared Nov 19, 2015
AN1087 Dosimeter
K150645 · JOJ
Andersen Sterilizers, Inc.
General Hospital · 252d
Cleared Nov 18, 2015
Clickfine AutoProtect Pen Needle
K152514 · FMI
Ypsomed AG
General Hospital · 77d
Cleared Nov 18, 2015
Tyvek Sterilization Pouches with Chevron Seal
K152058 · FRG
Andersen Sterilizers, Inc.
General Hospital · 117d
Cleared Nov 18, 2015
Andersen EOGas 4 SteriTest
K151585 · FRC
Andersen Sterilizers, Inc.
General Hospital · 160d
Cleared Nov 18, 2015
EOGas 4 Ethylene Oxide Gas Sterilizer
K150646 · FLF
Andersen Sterilizers, Inc.
General Hospital · 251d
Cleared Nov 18, 2015
AN85/AN86 EO Indicators
K150644 · JOJ
Andersen Sterilizers, Inc.
General Hospital · 251d
Cleared Nov 17, 2015
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K151682 · LYZ
Daxwell, LLC
General Hospital · 148d
Cleared Nov 16, 2015
Finessis Zero Flexylon Powder Free Sterile White Surgical Glove
K151607 · KGO
Lucenxia Prescience AG
General Hospital · 154d
Cleared Nov 16, 2015
Finessis Corium Flexylon Powder Free Sterile Green Surgical Gloves
K151605 · KGO
Lucenxia Prescience AG
General Hospital · 154d
Cleared Nov 16, 2015
Annuy Latex Patient Examination Glove (powdered and powder-free)
K150612 · LYY
Anhui Anyu Latex Products Co., Ltd.
General Hospital · 251d
Cleared Nov 16, 2015
Annuy Latex Surgeon's Gloves (Powdered and Powder Free)
K150609 · KGO
Anhui Anyu Latex Products Co., Ltd.
General Hospital · 251d
Cleared Nov 16, 2015
GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR...
K150504 · PSW
Pci Medical, Inc.
General Hospital · 263d
Cleared Nov 06, 2015
MEDLINE SHARPS CONTAINERS
K143693 · MMK
Medline Industries, Inc.
General Hospital · 317d
Cleared Nov 05, 2015
Equashield Closed System drug Transfer Device (CSTD)
K150219 · ONB
Equashield Medical , Ltd.
General Hospital · 279d
Cleared Nov 04, 2015
Safety Auto-Disable Syrine with Needle (Auto-Lock)
K143497 · MEG
Guangdong Intmed Medical Appliance...
General Hospital · 330d
Cleared Nov 02, 2015
EXELINT SecureTouch Safety Hypodermic Needle
K152183 · FMI
Exelint International, Co.
General Hospital · 89d
Cleared Nov 02, 2015
Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for...
K142941 · KGO
Pt. Medisafe Technologies
General Hospital · 389d
Cleared Oct 30, 2015
Cardinal Health Sterilization Wrap
K151788 · FRG
Cardinal Health200, LLC
General Hospital · 121d
Cleared Oct 29, 2015
STERRAD CYCLESURE 24 Biological Indicator
K151971 · FRC
Advanced Sterilization Products
General Hospital · 105d
Cleared Oct 29, 2015
Wire Sterilization Package with Indicators
K143117 · FRG
American Orthodontics
General Hospital · 364d
Cleared Oct 29, 2015
INSTRUMENT CASSETTE (EFCCL1-F)
K141854 · KCT
Osung Mnd Co., Ltd.
General Hospital · 477d
Cleared Oct 28, 2015
Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95...
K141876 · MSH
Pasture Pharma Pte, Ltd.
General Hospital · 474d
Cleared Oct 21, 2015
PICC Tip Positioning Aid
K152261 · LJS
Nostix, LLC
General Hospital · 71d