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
3457–3480 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 20, 2015
BT-400
K142332 · LBI
Bio-Med USA
General Hospital · 212d
Cleared Mar 19, 2015
NMI PICC III and NMI PICC IV
K150448 · LJS
Navilyst Medical, Inc.
General Hospital · 27d
Cleared Mar 19, 2015
MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
K141042 · LYY
Mercator Medical (Thailand), Ltd.
General Hospital · 330d
Cleared Mar 18, 2015
TULIP Natural Rubber Latex Surgeon's Glove (Powdered)
K142992 · KGO
Shanghai Jinxiang Latex Products Co.,...
General Hospital · 153d
Cleared Mar 16, 2015
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
K141929 · NDC
Roche Diagnostics Corporation
General Hospital · 243d
Cleared Mar 11, 2015
STERILIZATION POUCH/ROLL MADE WITH TYVEK
K133838 · FRG
Sigma Medical Supplies Corp.
General Hospital · 448d
Cleared Mar 09, 2015
KIMGUARD ONE-STEP Sterilization Wrap
K142782 · FRG
Kimberly-Clark Health Care
General Hospital · 164d
Cleared Mar 06, 2015
Patient Examination Gloves
K143419 · LYY
Hartalega NGC Sdn. Bhd.
General Hospital · 98d
Cleared Mar 05, 2015
SURGICAL GOWN
K141467 · FYA
Xuchang Zhengde Environstar Medical...
General Hospital · 275d
Cleared Mar 04, 2015
Hospira Blood Set
K143087 · FPA
Hospira, Inc.
General Hospital · 128d
Cleared Mar 04, 2015
Insta-Gard Surgical and Procedure Face Mask
K142990 · FXX
Cardinal Health200, LLC
General Hospital · 139d
Cleared Feb 26, 2015
IntraTemp Solution Warmer
K150190 · LHC
Ecolab, Inc.
General Hospital · 30d
Cleared Feb 26, 2015
EMMA
K150174 · NZH
Inrange Systems, Inc.
General Hospital · 31d
Cleared Feb 25, 2015
Hospira Primary Sets
K143015 · FPA
Hospira, Inc.
General Hospital · 128d
Cleared Feb 24, 2015
Endoscope Sterilization Tray
K142937 · KCT
Intuitive Surgical, Inc.
General Hospital · 138d
Cleared Feb 20, 2015
3S Safety Syringe with/without Needle
K142435 · MEG
Sincere Medical Device Co., Ltd.
General Hospital · 175d
Cleared Feb 19, 2015
3S Safety Insulin Syringe
K142436 · MEG
Sincere Medical Device Co., Ltd.
General Hospital · 174d
Cleared Feb 19, 2015
BUSSE EXTENSION SET
K141285 · FPA
Busse Hospital Disposables
General Hospital · 279d
Cleared Feb 13, 2015
ivWatch Model 400
K142374 · MRZ
Ivwatch, LLC
General Hospital · 171d
Cleared Feb 12, 2015
Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
K143131 · LZA
Kossan International Sdn Bhd
General Hospital · 104d
Cleared Feb 12, 2015
Non-Sterile, Powder Free Scented Blue Nitrile Examination Gloves - Grape,...
K143055 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 112d
Cleared Feb 12, 2015
INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF
K141087 · CAH
Intersurgical Incorporated
General Hospital · 290d
Cleared Feb 11, 2015
NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE
K142685 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 142d
Cleared Feb 09, 2015
POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)
K142858 · LZA
Careplus (M) Sdn Bhd
General Hospital · 131d