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
601–624 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 20, 2023
V-PRO maX 2 Low Temperature Sterilization System
K233065 · MLR
Steris
General Hospital · 24d
Cleared Oct 20, 2023
Nitrile Examination Gloves, Dual Color Black-Blue
K232550 · LZA
Shanxi Hongjin Plastic Technology...
General Hospital · 58d
Cleared Oct 20, 2023
GAMMEX PI Hybrid Micro (340002055)
K231902 · KGO
Ansell Healthcare
General Hospital · 114d
Cleared Oct 18, 2023
Medline Safety Insulin and TB Syringes
K231907 · MEG
Medline Industries, LP
General Hospital · 111d
Cleared Oct 18, 2023
Terumo Injection Filter Needle (NF-3013RBKE05M)
K230951 · QYM
Terumo Europe N.V.
General Hospital · 197d
Cleared Oct 17, 2023
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
K222214 · FXY
Thi Total Healthcare Innovation GmbH
General Hospital · 449d
Cleared Oct 14, 2023
Infrared Thermometer (AOJ-20A)
K232128 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 89d
Cleared Oct 12, 2023
Skypro, Surgical Gown 6021
K230707 · FYA
Skypro Medical Supplies Company
General Hospital · 212d
Cleared Oct 11, 2023
Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy...
K232070 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 91d
Cleared Oct 06, 2023
Vial Adapter
K232055 · LHI
Shanghai Lingfu Technology Co., Ltd.
General Hospital · 87d
Cleared Oct 06, 2023
Patient Examination Gloves
K230777 · LZA
3A Glove Sdn. Bhd.
General Hospital · 199d
Cleared Oct 06, 2023
Disposable Sterile Syringe
K221777 · FMF
Weihai Shengjie Medical Technology...
General Hospital · 472d
Cleared Oct 05, 2023
MESORAM® Hypodermic Needle (710301)
K230070 · FMI
Promamedical, Inc.
General Hospital · 268d
Cleared Oct 04, 2023
Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with...
K231567 · LZA
Better Care Plastic Technology Co., Ltd.
General Hospital · 126d
Cleared Oct 04, 2023
Copioumed Chemotherapy Isolation Gown
K230135 · FYC
Copioumed International, Inc.
General Hospital · 259d
Cleared Oct 03, 2023
enspire 300 Series Automated Endoscope Reprocessor
K232918 · NZA
STERIS Corporation
General Hospital · 14d
Cleared Oct 03, 2023
SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500)
K232914 · MED
STERIS Corporation
General Hospital · 14d
Cleared Oct 03, 2023
Orchid Safety Release ValveTM
K232094 · QOI
Linear Health Sciences, LLC
General Hospital · 82d
Cleared Oct 02, 2023
Surgical face mask
K232359 · FXX
Kingstar Medical (Xianning) Co., Ltd.
General Hospital · 56d
Cleared Oct 02, 2023
Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with...
K232064 · LZA
Isikel Manufacturing, LLC
General Hospital · 83d
Cleared Oct 02, 2023
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with...
K230681 · LZA
Central Medicare Sdn Bhd
General Hospital · 203d
Cleared Sep 29, 2023
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
K231973 · KGO
Ineo Tech Sdn Bhd
General Hospital · 88d
Cleared Sep 29, 2023
SafeBreak® Vascular
K231957 · QOI
Lineus Medical
General Hospital · 88d
Cleared Sep 29, 2023
Chemotherapy Gloves
K230847 · LZA
3A Glove Sdn. Bhd.
General Hospital · 185d