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
6505–6528 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 01, 2004
GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION...
K041188 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 26d
Cleared May 27, 2004
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
K031738 · LZG
Smiths Medical MD, Inc.
General Hospital · 358d
Cleared May 25, 2004
MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
K032914 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 246d
Cleared May 24, 2004
THINSET 1.8 ML RESERVOIR, MODEL 326A
K041152 · FRN
Applied Diabetes Research, Inc.
General Hospital · 21d
Cleared May 24, 2004
I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)
K040337 · MEB
I-Flow Corp.
General Hospital · 103d
Cleared May 21, 2004
NOA III ENTERAL NUTRITION PUMP
K040957 · LZH
Caesarea Medical Electronics , Ltd.
General Hospital · 38d
Cleared May 21, 2004
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
K040676 · LZG
Medtronic Minimed
General Hospital · 67d
Cleared May 19, 2004
CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH...
K040636 · FPA
Smiths Medical MD, Inc.
General Hospital · 70d
Cleared May 18, 2004
MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE
K032517 · MEG
Medsafe Technologies, LLC
General Hospital · 278d
Cleared May 14, 2004
POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH...
K040406 · LYY
Shun Thai Rubber Gloves Industry...
General Hospital · 87d
Cleared May 13, 2004
AIR SAFETY HEPA AND NON-HEPA FILTERS
K033008 · CAH
Air Safety, Ltd.
General Hospital · 230d
Cleared May 13, 2004
CLEAR-THERM MICRO HME, MODEL 1441
K032322 · CAH
Intersurgical, Inc.
General Hospital · 290d
Cleared May 12, 2004
10-SECOND DIGITAL THERMOMETER, MODELS ST87, ST89, ST80, ST88
K041056 · FLL
Mesure Technology Co., Ltd.
General Hospital · 19d
Cleared May 11, 2004
BIOTOP DJT-A SAFETY SYRINGE
K032747 · MEG
Biotop Technology Co., Ltd.
General Hospital · 250d
Cleared May 11, 2004
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC...
K032016 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 316d
Cleared May 07, 2004
E-Z LUBRICATING JELLY
K041060 · KMJ
Chester Labs, Inc.
General Hospital · 14d
Cleared May 07, 2004
LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING
K033789 · LZC
Cardinalhealth
General Hospital · 155d
Cleared May 07, 2004
LAFACI
K032400 · FYD
Vision Pro, LLC
General Hospital · 277d
Cleared May 06, 2004
MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
K041099 · FRC
Spsmedical Supply Corp.
General Hospital · 10d
Cleared May 05, 2004
KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS
K040196 · LZH
Tyco Healthcare/Kendall
General Hospital · 97d
Cleared May 03, 2004
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
K040936 · FQM
Leda Co., Ltd.
General Hospital · 24d
Cleared May 03, 2004
FIBREX CATHETER PATENCY DEVICE
K040427 · FOZ
Medical Device Technologies, Inc.
General Hospital · 74d
Cleared Apr 30, 2004
MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
K040899 · FRN
Medex, Inc.
General Hospital · 24d
Cleared Apr 30, 2004
EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021
K033077 · FLL
Metatech Co., Ltd.
General Hospital · 214d