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
6241–6264 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 05, 2005
INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE
K050131 · MEG
M.K. Meditech Co. , Ltd.
General Hospital · 74d
Cleared Apr 04, 2005
SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES
K050450 · LYZ
Zibo Blue Intco Plastic & Rubber...
General Hospital · 41d
Cleared Apr 04, 2005
CIDEX OPA CONCENTRATE
K032959 · MED
Advanced Sterilization Products
General Hospital · 559d
Cleared Apr 01, 2005
BLOOD HAND PUMP ADMINISTRATION SET
K050115 · BRZ
Cardinal Health, Alaris Products
General Hospital · 73d
Cleared Mar 30, 2005
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN
K050467 · LZA
Shen Wei (Usa), Inc.
General Hospital · 35d
Cleared Mar 30, 2005
NOVOFINE AUTOCOVER 30G X 8MM
K050106 · FMI
Novo Nordisk, Inc.
General Hospital · 71d
Cleared Mar 30, 2005
SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP
K043204 · FRN
Sgarlato Laboratories, Inc.
General Hospital · 132d
Cleared Mar 29, 2005
SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES
K050455 · LYZ
Zibo Blue Intco Plastic & Rubber...
General Hospital · 35d
Cleared Mar 29, 2005
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C
K043600 · FRN
Medtronic Minimed
General Hospital · 90d
Cleared Mar 25, 2005
PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES
K050295 · MQX
Helio Medical Supplies, Inc.
General Hospital · 46d
Cleared Mar 25, 2005
SE INFUSION SYSTEM WITH MMS
K043590 · FRN
Cardinal Health, Alaris Products
General Hospital · 87d
Cleared Mar 24, 2005
MRIDIUM 3850 MRI PUMP SYSTEM
K050301 · FRN
Iradimed Corporation
General Hospital · 44d
Cleared Mar 23, 2005
MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS
K050591 · FRC
Raven Biological Laboratories, Inc.
General Hospital · 15d
Cleared Mar 18, 2005
POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE)
K050531 · LZA
Spi Gloves Sdn. Bhd.
General Hospital · 16d
Cleared Mar 18, 2005
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200...
K050527 · LYY
Spi Gloves Sdn. Bhd.
General Hospital · 16d
Cleared Mar 18, 2005
TEMPTOUCH DERMAL THERMOMETER
K050137 · FLL
Xilas Medical, Inc.
General Hospital · 53d
Cleared Mar 18, 2005
ACCU-CHEK SPIRIT
K042887 · LZG
Disetronic Medical Systems AG
General Hospital · 150d
Cleared Mar 16, 2005
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,...
K050530 · LZA
Spi Gloves Sdn. Bhd.
General Hospital · 14d
Cleared Mar 16, 2005
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING...
K050529 · LYY
Spi Gloves Sdn. Bhd.
General Hospital · 14d
Cleared Mar 16, 2005
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
K050214 · LZA
Hartalega Sdn Bhd
General Hospital · 44d
Cleared Mar 16, 2005
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE
K050184 · KGO
Regent Medical Americas, LLC
General Hospital · 48d
Cleared Mar 16, 2005
STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011,...
K043004 · FYA
Viasys Medsystems
General Hospital · 135d
Cleared Mar 16, 2005
COMPEL MLR SURGICAL GOWNS
K041541 · FYA
Standard Textile Co., Inc.
General Hospital · 281d
Cleared Mar 16, 2005
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · KKX
Medline Industries, Inc.
General Hospital · 566d