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
3361–3384 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 02, 2015
BD Single Use, Hypodermic Syringe
K151766 · FMF
Becton, Dickinson and Company
General Hospital · 64d
Cleared Sep 02, 2015
TempTraq TT-100
K143267 · FLL
Blue Spark Technologies, Inc.
General Hospital · 293d
Cleared Aug 31, 2015
Biogel PI Micro Indicator Underglove
K150146 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 221d
Cleared Aug 31, 2015
Normal Saline Flush
K150143 · NGT
Nurse Assist, Inc.
General Hospital · 221d
Cleared Aug 28, 2015
NuVasive Sterilization Trays
K143579 · KCT
Nu Vasive, Incorporated
General Hospital · 253d
Cleared Aug 25, 2015
Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
K142760 · MQX
K.S. Choi Corporation
General Hospital · 334d
Cleared Aug 24, 2015
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs...
K151343 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 97d
Cleared Aug 20, 2015
Turbo High-Flow Non-coring Needle
K151341 · FMI
Norfolk Medical
General Hospital · 93d
Cleared Aug 18, 2015
Instru-Safe Instrument Protection System
K151166 · KCT
Summit Medical, Inc.
General Hospital · 109d
Cleared Aug 18, 2015
SterilContainer S
K143729 · KCT
Aesculap, Inc.
General Hospital · 232d
Cleared Aug 18, 2015
NON-STERILE, POWER FREE NITRILE EXAMINATION GLOVES-ORANGE, GREEN, BLUE AND...
K143289 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 274d
Cleared Aug 13, 2015
Accu-Chek FlexLink Plus infusion set
K143446 · FPA
Roche Diagnostics GmbH
General Hospital · 254d
Cleared Aug 11, 2015
Cathivex ¿GV filter units
K143583 · FPB
Merck Millipore , Ltd.
General Hospital · 236d
Cleared Aug 11, 2015
TM SAFETY NEEDLE
K142765 · FMI
Thinkmed Medical Technology Co., Ltd.
General Hospital · 320d
Cleared Aug 04, 2015
NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free,...
K150973 · KGO
Terang Nusa Snd Bhd
General Hospital · 113d
Cleared Jul 31, 2015
SmartSite Vented Vial Access Device
K151963 · LHI
Yukon Medical, LLC
General Hospital · 15d
Cleared Jul 31, 2015
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
K150874 · FMF
Novo Nordisk, Inc.
General Hospital · 121d
Cleared Jul 29, 2015
Cream Stretch Vinyl Patient Examination Glove (Non-Sterile),White Vinyl...
K143277 · LYZ
Lifestyle Safety Products (Hui Zhou)...
General Hospital · 257d
Cleared Jul 27, 2015
BD Angiocath IV Catheter, BD Insyte IV Catheter
K151698 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 33d
Cleared Jul 24, 2015
Halo
K150486 · ONB
J & J Solutions, Inc. D/B/A/ Corvida...
General Hospital · 150d
Cleared Jul 24, 2015
Powder-Free Yellow Vinyl Patient Examination Gloves
K143347 · LYZ
Zibo Zhouheng Plastic Products Co., Ltd.
General Hospital · 245d
Cleared Jul 24, 2015
IV Administration Sets with 200(micro)m Blood Filter
K143082 · FPA
B.Braun Medical, Inc.
General Hospital · 270d
Cleared Jul 22, 2015
Powder-Free White Vinyl Patient Examination Gloves
K143346 · LYZ
Zibo Changda Plastic Products...
General Hospital · 243d
Cleared Jul 15, 2015
EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR,...
K150903 · MQX
Maanshan Bond Medical Instruments...
General Hospital · 103d