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
4321–4344 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 06, 2011
INFRARED EAR THERMOMETER
K111637 · FLL
Radiant Innovation, Inc.
General Hospital · 176d
Cleared Dec 05, 2011
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)
K112610 · LYZ
Inpro Technology Device Factory
General Hospital · 89d
Cleared Dec 01, 2011
AMSCO V-PRO
K112813 · MLR
Steris Corp
General Hospital · 65d
Cleared Dec 01, 2011
GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS
K111458 · KKX
Gri Medical & Electronic Technology...
General Hospital · 189d
Cleared Dec 01, 2011
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVES (ORIGINAL BLUE, COBALT BLUE)
K111248 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 212d
Cleared Nov 30, 2011
DIGNITY MINI PORT- ATTACHABLE
K110424 · LJT
Medcomp ( Medical Components)
General Hospital · 289d
Cleared Nov 28, 2011
BD EMERALD SINGLE USE, HYPODERMIC SYRINGE
K113241 · FMF
Becton Dickinson
General Hospital · 26d
Cleared Nov 26, 2011
CYTOGUARD(TM) CLOSED LUER CONNECTOR
K112636 · FPA
B.Braun Medical, Inc.
General Hospital · 78d
Cleared Nov 22, 2011
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
K112760 · MLR
STERIS Corporation
General Hospital · 61d
Cleared Nov 17, 2011
POWER FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
K113191 · LYZ
Suqian Ruijang Medical Supplies Co.,...
General Hospital · 17d
Cleared Nov 16, 2011
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K113195 · LYZ
Suqian Ruijang Medical Supplies Co.,...
General Hospital · 16d
Cleared Nov 10, 2011
XTRACT SYRINGE KEY SYSTEM
K112475 · FMF
Xtract Solutions
General Hospital · 73d
Cleared Nov 09, 2011
POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50...
K112988 · LYY
Northstar Healthcare Holdings Limited
General Hospital · 34d
Cleared Nov 09, 2011
CATHETER CONNECTIONS' DUALCAP DUO
K112985 · QBP
Catheter Connections, Inc.
General Hospital · 34d
Cleared Nov 09, 2011
T:SLIM (TM) INSULIN DELIVERY SYSTEM
K111210 · LZG
Tandem Diabetes Care, Inc.
General Hospital · 194d
Cleared Nov 04, 2011
SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
K111923 · LYY
Pt. Intan Hevea Industry
General Hospital · 120d
Cleared Nov 04, 2011
WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
K111392 · MQX
Woojeon Company
General Hospital · 170d
Cleared Nov 04, 2011
INTERDRY SILVER
K110715 · FRL
Milliken Healthcare Products, LLC
General Hospital · 234d
Cleared Nov 04, 2011
MEDISIZE RED AND MEDISIZE BLUE
K110246 · CAH
Qserve America, Inc.
General Hospital · 281d
Cleared Oct 28, 2011
SYRINGES AND NEEDLES
K113091 · FMF
Jiangyin Caina Technology Co., Ltd.
General Hospital · 9d
Cleared Oct 27, 2011
NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS
K112713 · LJT
Norfolk Medical Products, Inc.
General Hospital · 38d
Cleared Oct 27, 2011
ALCATRON AND / OR MULTIPLE BRAND
K112222 · LYZ
Alcatron Gloves Factory
General Hospital · 86d
Cleared Oct 20, 2011
SAPIENS TIP CONFIRMATION SYSTEM
K112744 · LJS
C.R. Bard, Inc.
General Hospital · 29d
Cleared Oct 20, 2011
VANISHPOINT BLOOD COLLECTION SET
K112512 · FPA
Retractable Technologies, Inc.
General Hospital · 51d