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
2449–2472 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 24, 2019
Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator...
K190077 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 128d
Cleared May 24, 2019
Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K182575 · LYZ
Jiangxi Jaysun Medcare Co., Ltd.
General Hospital · 247d
Cleared May 23, 2019
Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with...
K190018 · KGO
Ansell Healthcare Products, LLC
General Hospital · 139d
Cleared May 20, 2019
OnSite Waste Sharps Container
K182235 · MMK
Bluestone Medical, Inc.
General Hospital · 276d
Cleared May 17, 2019
Cook Unimpregnated Central Venous Catheter
K182252 · FOZ
Cook Incorporated
General Hospital · 270d
Cleared May 14, 2019
Celerity HP Incubator
K190297 · FRC
STERIS Corporation
General Hospital · 92d
Cleared May 13, 2019
PIVO
K190604 · JKA
Velano Vascular
General Hospital · 66d
Cleared May 10, 2019
Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet...
K182612 · LZA
Zibo Yahao Supplies Co., Ltd.
General Hospital · 231d
Cleared May 09, 2019
V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature...
K190917 · MLR
STERIS Corporation
General Hospital · 30d
Cleared May 09, 2019
DePuy Synthes Sterilization Container System
K181933 · KCT
Synthes (Usa) Products, LLC / Depuy...
General Hospital · 294d
Cleared May 07, 2019
Stryker ChestShield Sterilization Tray System
K183701 · KCT
Paragon Medical
General Hospital · 127d
Cleared May 07, 2019
SteriCap Mini Needle
K183016 · FMI
Ocujet, LLC
General Hospital · 188d
Cleared May 07, 2019
Neodent Instruments Kits
K182865 · KCT
Jjgc Industria E Comercio DE...
General Hospital · 208d
Cleared May 06, 2019
Unity Subcutaneous Delivery System for Remodulin
K190182 · FRN
DEKA Research & Development
General Hospital · 94d
Cleared May 06, 2019
Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
K190159 · LZC
Showa Best Glove, Inc.
General Hospital · 96d
Cleared May 05, 2019
Wireless Intelligent Thermometer
K182437 · FLL
Shenzhen Jumper Medical Equipment...
General Hospital · 240d
Cleared May 02, 2019
K-Shield Advantage Port Access Infusion Set (PAIS)
K190233 · FPA
Kawasumi Laboratories, Inc.
General Hospital · 85d
Cleared Apr 30, 2019
Additive Cap
K190305 · KPE
International Medical Industries, Inc.
General Hospital · 77d
Cleared Apr 30, 2019
BD Intelliport System
K182092 · PHC
Becton, Dickinson and Company
General Hospital · 270d
Cleared Apr 26, 2019
Cardinal HealthTM Poly-Coated Open-Back Protective Gown
K182830 · QPC
Cardinal Health200, LLC
General Hospital · 203d
Cleared Apr 24, 2019
Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown...
K182172 · FYA
Medline Industries, Inc.
General Hospital · 257d
Cleared Apr 23, 2019
Elcam Stopcocks and Manifolds
K190489 · FMG
Elcam Medical Acal
General Hospital · 54d
Cleared Apr 23, 2019
AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
K181472 · FEB
Advanced Sterilization Products (Asp)
General Hospital · 323d
Cleared Apr 12, 2019
TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner...
K182891 · PSW
Cs Medical, LLC
General Hospital · 179d