Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
2401–2424 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 15, 2019
Medtronic Transportation / Sterilization Cassettes
K190840 · KCT
Medtronic Sofamor Danek USA, Inc.
General Hospital · 197d
Cleared Oct 15, 2019
Vial Adapter Ø20 mm
K190149 · LHI
Avenir Performance Europeenne Medical...
General Hospital · 259d
Cleared Oct 11, 2019
K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2”...
K192057 · FMI
Terumo Europe N.V.
General Hospital · 71d
Cleared Oct 10, 2019
ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
K192210 · FLL
Fiab Spa
General Hospital · 57d
Cleared Oct 10, 2019
Halyard ONE-STEP* Sterilization Wrap
K192147 · FRG
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 63d
Cleared Oct 10, 2019
Instylla Delivery Kit
K191659 · FMF
Instylla, Inc.
General Hospital · 111d
Cleared Oct 10, 2019
Mercy babyTAPE
K191174 · PIR
Children'S Mercy Hospital
General Hospital · 162d
Cleared Oct 10, 2019
Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization...
K182184 · FRG
Mdk (Shanghai) Medical Packing Co., Ltd.
General Hospital · 423d
Cleared Oct 09, 2019
Nipro Syringe
K191359 · FMF
Nipro Medical Corporation
General Hospital · 141d
Cleared Oct 07, 2019
NIO-I
K190538 · FMI
Waismed, Ltd.
General Hospital · 217d
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