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
3289–3312 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 30, 2015
Navigator Aesthetic Delivery System
K151255 · FRN
Carticept Medical, Inc.
General Hospital · 232d
Cleared Dec 29, 2015
SpectraShield 9500 Surgical N95 Respirator
K150729 · ONT
Nexera Medical, Inc.
General Hospital · 284d
Cleared Dec 28, 2015
Solution Administration Sets with 0.2 Micron Filter
K153158 · FPA
Baxter Healthcare Corporation
General Hospital · 56d
Cleared Dec 28, 2015
Advanced Imaging Modality (AIM) Sterilization Tray, Endoscope and Camera...
K152951 · KCT
Paragon Medical, Inc.
General Hospital · 83d
Cleared Dec 24, 2015
Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential...
K152542 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 111d
Cleared Dec 21, 2015
Powder Free Vinyl Patient Examination Gloves (Green)
K152692 · LYZ
Supermax Plastic Products Co., Ltd.
General Hospital · 91d
Cleared Dec 21, 2015
Cardinal Health Sterilization Wrap
K151445 · FRG
Cardinal Health200, LLC
General Hospital · 206d
Cleared Dec 21, 2015
Powder Free Vinyl Patient Examination Glove (Non?-Sterile)
K150934 · LYZ
Lpl (Hui Zhou) Glove
General Hospital · 259d
Cleared Dec 18, 2015
Breathing circuit bacterial/viral filter
K151498 · CAH
Zhejiang Haisheng Medical Device Co.,...
General Hospital · 197d
Cleared Dec 17, 2015
Sterisheet Sterilization Wrap
K152291 · FRG
Andersen Sterilizers, Inc.
General Hospital · 126d
Cleared Dec 14, 2015
Disposable Infusion Needle, Safelock Disposable Infusion Needle
K152323 · FPA
Jiangyin Caina Technology Co., Ltd.
General Hospital · 119d
Cleared Dec 11, 2015
BD FlowSmart Set, MiniMed Pro-Set
K153257 · FPA
Becton, Dickinson and Company
General Hospital · 31d
Cleared Dec 11, 2015
Safelock Disposable Blood Collection Set, Disposable Blood Collection Set
K151991 · FPA
Jiangyin Caina Technology Co., Ltd.
General Hospital · 144d
Cleared Dec 11, 2015
Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex...
K151114 · KGO
St. Marys Rubbers Pvt, Ltd.
General Hospital · 228d
Cleared Dec 10, 2015
AccuCath Intravascular Catheter
K153298 · FOZ
C.R. Bard, Inc.
General Hospital · 27d
Cleared Dec 07, 2015
Merit 20 mL Syringe
K152783 · FMF
Merit Medical Systems, Inc.
General Hospital · 73d
Cleared Dec 04, 2015
NMI Port, NMI Port II
K153228 · LJT
Navilyst Medical, Inc.
General Hospital · 28d
Cleared Dec 04, 2015
KIRO Set
K152441 · LHI
Kiro Robotics S.L.
General Hospital · 99d
Cleared Dec 02, 2015
Universal Spike
K150787 · LHI
B.Braun Medical, Inc.
General Hospital · 252d
Cleared Dec 01, 2015
3M Attest Rapid Readout Biological Indicator 1295
K152060 · FRC
3M Company
General Hospital · 130d
Cleared Nov 27, 2015
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K151679 · LYZ
Heze Yuze Glove Co., Ltd.
General Hospital · 158d
Cleared Nov 27, 2015
SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove,...
K150238 · KGO
Medline Industries, Inc.
General Hospital · 298d
Cleared Nov 23, 2015
Arrow Endurance Extended Dwell Peripheral Catheter System
K152272 · FOZ
Arrow International, Inc. (Subsidiary...
General Hospital · 103d
Cleared Nov 20, 2015
Gemini Sterilization Wrap
K150698 · FRG
Medline Industries, Inc.
General Hospital · 247d