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
6313–6336 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jan 07, 2005
TRUGRAFT BGS SYRINGE, MODEL 600-041
K043172 · FMF
Osteobiologics, Inc.
General Hospital · 52d
Cleared Jan 04, 2005
PHARMGUARD TOOLBOX, MODEL G6000782
K042432 · FRN
Medex, Inc.
General Hospital · 118d
Cleared Jan 03, 2005
IXL-II DIABETES MANAGEMENT SYSTEM
K042792 · LZG
Insulet Corporation
General Hospital · 89d
Cleared Dec 29, 2004
MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE
K043397 · FMI
Becton, Dickinson & CO
General Hospital · 19d
Cleared Dec 29, 2004
ACUPUNCTURE NEEDLES
K041652 · MQX
C.A.I. Industries Corp.
General Hospital · 195d
Cleared Dec 27, 2004
CLINICAL ELECTRONIC THERMOMETER
K032434 · FLL
Cotronic Manufacturing
General Hospital · 509d
Cleared Dec 22, 2004
BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML
K043038 · MEG
Biotop Technology Co., Ltd.
General Hospital · 48d
Cleared Dec 22, 2004
NEEDLE INCAPACITATOR (NEEDLE GUARD)
K042907 · FMI
Pdmp, Inc.
General Hospital · 62d
Cleared Dec 22, 2004
EAR THERMOMETER, MODEL WL-320X
K042631 · FLL
Innovatech, Inc.
General Hospital · 86d
Cleared Dec 22, 2004
NEOSCI MEDICAL ENDOLUMINAL BRUSH
K030400 · LJS
Neosci Medical, Inc.
General Hospital · 685d
Cleared Dec 21, 2004
THE RELIANCE PI PROCESS INDICATOR, MODEL D5116
K043482 · JOJ
STERIS Corporation
General Hospital · 4d
Cleared Dec 21, 2004
LUTH-ALL SUB-Q NEEDLE SET
K042666 · FPA
Luth-All Medical Products, LLC
General Hospital · 83d
Cleared Dec 21, 2004
CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
K041038 · KPE
Churchill Medical Systems, Inc.
General Hospital · 243d
Cleared Dec 20, 2004
POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE,...
K043159 · LYZ
Shijaizhuang Brilliant Ocean Plastic...
General Hospital · 35d
Cleared Dec 17, 2004
PROTECTION PLUS EARLOOP PROCEDURE MASK
K042654 · FXX
Safety-Med Products, Inc.
General Hospital · 80d
Cleared Dec 17, 2004
THE RELIANCE ENDOSCOPE PROCESSING SYSTEM
K040049 · NZA
STERIS Corporation
General Hospital · 340d
Cleared Dec 16, 2004
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE
K042805 · LZC
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 65d
Cleared Dec 16, 2004
FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE
K042239 · LZA
Pt. Mandiri Inti Buana
General Hospital · 120d
Cleared Dec 13, 2004
ALL FLOW PULMONARY FUNCTION FILTER
K043148 · CAH
Alliance Tech Medical, Inc.
General Hospital · 28d
Cleared Dec 13, 2004
REUSABLE STERILCONTAINER FILTER MODEL #JK090
K041623 · FRG
Aesculap, Inc.
General Hospital · 180d
Cleared Dec 10, 2004
MEDLEY PCA MODULE, MODEL 8120
K043299 · MEA
Alaris Medical Systems, Inc.
General Hospital · 10d
Cleared Dec 10, 2004
ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
K042873 · LZG
Animas Corp.
General Hospital · 53d
Cleared Dec 10, 2004
IR VIEWER
K042679 · KZA
Infrared Imaging Systems, Inc.
General Hospital · 72d
Cleared Dec 10, 2004
KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304
K042461 · LJS
Kendall
General Hospital · 91d