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
2593–2616 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 28, 2018
Endoscope Sterilization Tray
K180964 · KCT
Intuitive Surgical, Inc.
General Hospital · 169d
Cleared Sep 28, 2018
Kawasumi Laboratories Blood Drawing Kit (BDK) System
K172957 · KSB
Kawasumi Laboratories, Inc.
General Hospital · 367d
Cleared Sep 27, 2018
PureSet Tray
K181075 · KCT
Nobel Biocare AB
General Hospital · 156d
Cleared Sep 26, 2018
Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and...
K181066 · LZA
Eco Medi Glove Sdn. Bhd.
General Hospital · 156d
Cleared Sep 25, 2018
5 FR Dual Lumen Piper PICC
K181904 · LJS
Piper Access, LLC
General Hospital · 71d
Cleared Sep 24, 2018
Probe Covers for Thermometers
K180714 · FLL
K-Jump Health Co., Ltd.
General Hospital · 189d
Cleared Sep 21, 2018
Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)
K182043 · LYZ
Hebei Titans Hongsen Medical...
General Hospital · 53d
Cleared Sep 21, 2018
TEVADAPTOR Closed Drug Reconstitution and Transfer System
K180489 · ONB
Teva Medical Ltd., Migada Plant
General Hospital · 210d
Cleared Sep 20, 2018
EndoTool SubQ
K180366 · NDC
Al Pacheco and Associates
General Hospital · 220d
Cleared Sep 07, 2018
Ultravision™ Visual Field Clearing System
K182053 · PQM
Alesi Surgical, Ltd.
General Hospital · 38d
Cleared Sep 05, 2018
AMSafe Sure-Lok Needle-Free Connector
K173665 · FPA
Amsino International, Inc.
General Hospital · 280d
Cleared Aug 31, 2018
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
K173477 · ONB
Icu Medical, Inc.
General Hospital · 291d
Cleared Aug 28, 2018
Disposable Insulin Pen Needle
K181069 · FMI
Zhejiang Kindly Medical Devices Co.,...
General Hospital · 127d
Cleared Aug 21, 2018
Fever Scout
K181013 · FLL
VivaLNK, Inc.
General Hospital · 126d
Cleared Aug 20, 2018
BD Vacutainer Eclipse Signal Blood Collection Needle
K170824 · FMI
Becton, Dickinson and Company
General Hospital · 518d
Cleared Aug 17, 2018
Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck...
K180574 · ONB
J & J Solutions, Inc. D/B/A/ Corvida...
General Hospital · 165d
Cleared Aug 17, 2018
NuBorne Infant Warmer
K173516 · FMT
International Biomedical
General Hospital · 276d
Cleared Aug 17, 2018
Biodegradable Nitrile Powder Free Examination Glove (Blue)
K173509 · LZA
Hartalega Sdn Bhd
General Hospital · 277d
Cleared Aug 14, 2018
Vicks RapidRead Digital Thermometer
K180131 · FLL
Kaz USA, Inc., A Helen of Troy Company
General Hospital · 209d
Cleared Aug 10, 2018
Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy...
K181130 · LZC
Hebei Titans Hongsen Medical...
General Hospital · 102d
Cleared Aug 10, 2018
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
K180644 · LZA
Hartalega Sdn Bhd
General Hospital · 151d
Cleared Aug 10, 2018
Diana Medication Transfer Set
K170110 · ONB
Icu Medical, Inc.
General Hospital · 575d
Cleared Aug 09, 2018
Self-destruction Safety Syringes for Single Use
K180417 · MEG
Berpu Medical Technology Co., Ltd.
General Hospital · 175d
Cleared Aug 08, 2018
Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical...
K180221 · KGO
Smart Glove Corporation Sdn. Bhd.
General Hospital · 195d