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
553–576 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 15, 2023
ConFirm 20 Minute Incubator
K233681 · FRC
STERIS Corporation
General Hospital · 29d
Cleared Dec 15, 2023
Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue)
K233182 · LZA
Zibo Kaiyue Mould Technology Co., Ltd.
General Hospital · 78d
Not Cleared Dec 15, 2023
Body Temperature Software (BTS)
DEN230050 · QZA
Fitbit, LLC
General Hospital · 151d
Cleared Dec 14, 2023
Vial Adapter 20mm
K232875 · LHI
West Pharma Services Il, Ltd.
General Hospital · 90d
Cleared Dec 12, 2023
Aygün Sterilization Container Systems
K233222 · KCT
Aygun Surgical Instruments Co., Inc.
General Hospital · 75d
Cleared Dec 12, 2023
Sterile Hypodermic Needles for Single Use
K233037 · FMI
Zhejiang Kindly Medical Device Co., Ltd.
General Hospital · 78d
Cleared Dec 11, 2023
Hygenix
K232797 · FXX
Shenzhen Hygenix Industrial Co., Ltd.
General Hospital · 90d
Cleared Dec 08, 2023
VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical...
K233654 · JOJ
Steris
General Hospital · 24d
Cleared Dec 08, 2023
PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port
K232737 · LJT
Bard Peripheral Vascular, Inc.
General Hospital · 92d
Cleared Dec 07, 2023
Reliance® Fusion Sterilization Wraps
K230137 · FRG
Ahlstrom-Munksjo Nonwovens, LLC
General Hospital · 323d
Cleared Dec 06, 2023
Sterile Nitrile Examination Gloves Powder Free Tested for Use with...
K233042 · LZA
Shandong Intco Medical Products Co, Ltd.
General Hospital · 72d
Cleared Dec 05, 2023
Aurelia Surgical Mask ASTM Level 1
K231005 · FXX
Supermax Healthcare Canada-Supermax...
General Hospital · 242d
Cleared Dec 05, 2023
THERMOCLICK
K222057 · FLL
T&R BIOFAB CO., Ltd.
General Hospital · 511d
Cleared Dec 04, 2023
Monarch Blood Collection Set
K232308 · JKA
The Monarch Company
General Hospital · 124d
Cleared Dec 01, 2023
BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free...
K233529 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 29d
Cleared Dec 01, 2023
CATHTONG III Tapered PICC Catheter
K233149 · LJS
L&Z Us, Inc.
General Hospital · 65d
Cleared Dec 01, 2023
Vial2Bag Advanced® 13mm Admixture Device
K230988 · LHI
West Pharma Services Il, Ltd.
General Hospital · 239d
Cleared Dec 01, 2023
Extension Set
K230528 · FPA
Medcaptain Life Science Co., Ltd.
General Hospital · 277d
Cleared Nov 30, 2023
NavaClick Injection System
K231877 · FMF
Lineage Biomedical, Inc.
General Hospital · 157d
Cleared Nov 30, 2023
L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters
K230669 · LJS
Argon Medical Devices
General Hospital · 265d
Cleared Nov 30, 2023
Insulin Syringe
K230061 · FMF
Anhui Hongyu Wuzhou Medical...
General Hospital · 325d
Cleared Nov 28, 2023
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K232252 · LZA
Dehai (Shandong) Medical Gloves, Co.,...
General Hospital · 123d
Cleared Nov 28, 2023
VersaPump Infusion System
K230883 · PKP
Emed Technologies Corporation
General Hospital · 243d
Cleared Nov 27, 2023
SteriCap Safety Needle
K233343 · FMI
Ocuject, LLC
General Hospital · 59d