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
2377–2400 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 04, 2019
Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe
K190183 · MEG
Anhui Hongyu Wuzhou Medical...
General Hospital · 245d
Cleared Oct 04, 2019
Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile,...
K183441 · LZA
Semperit Investments Asia Pte , Ltd.
General Hospital · 296d
Cleared Oct 03, 2019
Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable...
K191490 · MEG
Jiangsu Caina Medical Co.,Ltd
General Hospital · 120d
Cleared Sep 26, 2019
PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors,...
K190466 · LZA
Shen Wei (Usa), Inc.
General Hospital · 212d
Cleared Sep 26, 2019
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K190454 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 213d
Cleared Sep 25, 2019
SafeBreath Filter Mouthpiece
K190022 · CAH
MD Diagnostics Limited
General Hospital · 264d
Cleared Sep 20, 2019
Supercath 5
K190001 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 261d
Cleared Sep 18, 2019
AccuCath Ace Intravascular Catheter
K191232 · FOZ
C.R. Bard, Inc.
General Hospital · 133d
Cleared Sep 17, 2019
Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level...
K190308 · OXZ
Amd Medicom, Inc.
General Hospital · 217d
Cleared Sep 16, 2019
Sterile Powder Free Nitrile Examination Glove, Blue Colored, with...
K191800 · LZA
Kossan International Sdn Bhd
General Hospital · 75d
Cleared Sep 15, 2019
0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
K191378 · NGT
Medline Industries, Inc.
General Hospital · 115d
Cleared Sep 13, 2019
Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape,...
K191021 · FRC
Terragene S.A.
General Hospital · 149d
Cleared Sep 13, 2019
Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
K190005 · MLR
Sterilucent, Inc.
General Hospital · 254d
Cleared Sep 12, 2019
Sterile Hypodermic Syringe for Single use, with/without needle, Sterile...
K190002 · FMF
Shanghai Kohope Medical Devices Co.,...
General Hospital · 253d
Cleared Sep 11, 2019
3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure...
K191355 · FXX
3M Healthcare
General Hospital · 113d
Cleared Sep 09, 2019
Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT...
K183444 · LDS
Cenorin, LLC
General Hospital · 271d
Cleared Sep 06, 2019
Sure-Fine Insulin Syringes
K191531 · FMF
Shina Med Corporation
General Hospital · 88d
Cleared Sep 06, 2019
Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With...
K190403 · LZA
Ever Global (Vietnam) Enterprise...
General Hospital · 199d
Cleared Sep 06, 2019
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile...
K183665 · MEG
Jiangsu Micsafe Medical Technology...
General Hospital · 253d
Cleared Sep 06, 2019
Reusable Temperature Probe
K182751 · FLL
Shenzhen Caremed Medical Technology...
General Hospital · 343d
Cleared Sep 05, 2019
Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator...
K192020 · JOJ
STERIS Corporation
General Hospital · 38d
Cleared Sep 05, 2019
Dual-Safety Pen Needle
K191853 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 57d
Cleared Sep 05, 2019
SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900
K191343 · MED
STERIS Corporation
General Hospital · 108d
Cleared Sep 05, 2019
Advocate Non-Contact Infrared Thermometer
K191004 · FLL
Broadmaster Biotech, Corp.
General Hospital · 142d