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
6409–6432 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 16, 2004
RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES
K040377 · FLL
Radiant Innovation, Inc.
General Hospital · 212d
Cleared Sep 15, 2004
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVES
K042214 · LYZ
Shandong Perfect Plastic Co., Ltd.
General Hospital · 30d
Cleared Sep 13, 2004
SAFE T RETRACTABLE BLOOD COLLECTION DEVICE
K041941 · FMI
Safe T Medical Devices, Ltd.
General Hospital · 56d
Cleared Sep 13, 2004
RAVEN PROTEST - EO
K041784 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 74d
Cleared Sep 13, 2004
DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER...
K041694 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 83d
Cleared Sep 13, 2004
INFRARED EAR THERMOMETER, ET-100 SERIES
K041692 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 83d
Cleared Sep 10, 2004
TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302, DT-312, DT-412,...
K042202 · FLL
Oriental System Technology, Inc.
General Hospital · 28d
Cleared Sep 09, 2004
PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
K042213 · LYZ
Shandong Perfect Plastic Co., Ltd.
General Hospital · 24d
Cleared Sep 09, 2004
PREMICATH, 1261.205
K041468 · LJS
Vygon Corp.
General Hospital · 99d
Cleared Sep 09, 2004
STERITEC EMU-GRAPH, MODEL NO. CI 131/US
K040901 · JOJ
Steritec Products, Inc.
General Hospital · 155d
Cleared Sep 08, 2004
MODIFICATION TO: LIFTLOC SAFTEY INFUSION SET
K042234 · FPA
Specialty Health Products, Inc.
General Hospital · 21d
Cleared Sep 08, 2004
DIGITAL CLINICAL THERMOMETER, MODELS ST-8A3C AND ST-8A3F
K042013 · FLL
Mesure Technology Co., Ltd.
General Hospital · 43d
Cleared Sep 08, 2004
DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9
K041516 · FLL
Vega Technologies, Inc.
General Hospital · 96d
Cleared Sep 03, 2004
ALL SAFE HUBER SAFETY INFUSION SETS
K041844 · FPA
Nexus Medical, LLC
General Hospital · 57d
Cleared Sep 02, 2004
SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
K042247 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 14d
Cleared Sep 01, 2004
Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432
K042182 · FPA
Icu Medical, Inc.
General Hospital · 21d
Cleared Aug 31, 2004
MULTI-DRIP INFUSION CATHETER
K042246 · MEB
Advanced Infusion, Inc.
General Hospital · 12d
Cleared Aug 31, 2004
PRE-POWDERED VINYL EXAM GLOVES
K041379 · LYZ
Shijiazhuang Wally Plastics Co., Ltd.
General Hospital · 99d
Cleared Aug 27, 2004
PICC
K042126 · LJS
Arrow Intl., Inc.
General Hospital · 21d
Cleared Aug 27, 2004
CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES
K042101 · LZA
Seal Polymer Industries Bhd.
General Hospital · 23d
Cleared Aug 26, 2004
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
K042121 · FRN
Sigma Intl.
General Hospital · 20d
Cleared Aug 26, 2004
0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
K042061 · NGT
Becton Dickinson
General Hospital · 24d
Cleared Aug 26, 2004
SABRESOURCE DRAPE
K041846 · KKX
Minrad, Inc.
General Hospital · 49d
Cleared Aug 26, 2004
AUTOFUSER AMBULATORY INFUSION PUMP
K041585 · MEB
Algos, LC
General Hospital · 73d