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
3025–3048 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 06, 2017
NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS...
K162923 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 111d
Cleared Feb 03, 2017
PICC Maximal Barrier Nursing Kit
K163452 · LJS
Navilyst Medical, Inc.
General Hospital · 56d
Cleared Feb 02, 2017
NovaGuard SA Pro Safety System
K163511 · MEG
West Pharmaceutical Services, Inc.
General Hospital · 49d
Cleared Feb 02, 2017
0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
K161552 · NGT
Becton, Dickinson and Company
General Hospital · 241d
Cleared Jan 31, 2017
HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with...
K162381 · LZA
Healthy Glove Co., Ltd.
General Hospital · 160d
Cleared Jan 31, 2017
Medline Non-Surgical Isolation Gown-
K160471 · FYC
Medline Industries, Inc.
General Hospital · 347d
Cleared Jan 27, 2017
VERIFY STEAM Integrating Indicator - Short
K162631 · JOJ
STERIS Corporation
General Hospital · 128d
Cleared Jan 24, 2017
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K162924 · LZA
Hartalega Sdb. Bhd.
General Hospital · 98d
Cleared Jan 23, 2017
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy...
K161823 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 206d
Cleared Jan 19, 2017
Fever Scout™ Continuous Monitoring thermometer
K162137 · FLL
VivaLNK, Inc.
General Hospital · 171d
Cleared Jan 19, 2017
meso-relle (AAL34, AAL36, AM30G)
K161255 · FMI
Biotekne Srl
General Hospital · 261d
Cleared Jan 19, 2017
Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
K160589 · PQX
Certa Dose, Inc.
General Hospital · 324d
Cleared Jan 12, 2017
WellDoc BlueStar, WellDoc BlueStar Rx
K162532 · MRZ
Welldoc, Inc.
General Hospital · 125d
Cleared Jan 11, 2017
ConceptoMed Luer-Jack Slip 10ml
K162057 · FMF
Conceptomed AS
General Hospital · 169d
Cleared Jan 09, 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Tested for...
K162819 · LZA
Hartalega Sdn Bhd
General Hospital · 95d
Cleared Jan 09, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and...
K162818 · LZA
Hartalega Sdn Bhd
General Hospital · 95d
Cleared Jan 09, 2017
RII Multi-function Infrared Thermometer, Model TH52Z
K162083 · FLL
Radiant Innovation, Inc.
General Hospital · 166d
Cleared Jan 06, 2017
Hospira Extension Set, Hospira Primary Set
K161036 · FPA
Hospira, Inc.
General Hospital · 268d
Cleared Jan 05, 2017
Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)
K162146 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 157d
Cleared Dec 29, 2016
Disposable Insulin Syringe
K162180 · FMF
Berpu Medical Technology Co., Ltd.
General Hospital · 147d
Cleared Dec 28, 2016
Hang&Go PAC
K161613 · LGZ
Rand S.R.L.
General Hospital · 201d
Cleared Dec 22, 2016
ivWatch
K162478 · PMS
Ivwatch, LLC
General Hospital · 107d
Cleared Dec 22, 2016
Go Dose System
K160949 · NDC
Eli Lilly and Company
General Hospital · 261d
Cleared Dec 22, 2016
VPS Rhythm Device with TipTracker Technology
K160925 · LJS
Arrow International, Inc. (A...
General Hospital · 262d