40 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 2, 2015
AC Powered hospital adjustable bed.
FDA Enforcement
Class II
·Terminated·Umano Medical, Inc.·June 10, 2020
EVIS EXERA III Bronchovideoscope
FDA Enforcement
Class II
·Terminated·Aizu Olympus Co., Ltd.·August 31, 2022
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·June 20, 2018
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·June 20, 2018
IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·June 20, 2018
Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
FDA Enforcement
Class II
·Terminated·Sheffield Pharmaceuticals, LLC·July 8, 2015
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·August 13, 2014
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·August 13, 2014
B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
FDA Enforcement
Class II
·Terminated·Cardinal Health Inc.·May 27, 2020
O.B. Pack, Catalog number 900-645. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
O.B. PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
O.B. PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank. product Usage: Provides sterile environment to protect patient from infection
FDA Enforcement
Class II
·Terminated·Certified Safety Mfg Inc·September 6, 2017
O.B. PACK 4/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
O.B. PACK HOSPITAL 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
FDA Enforcement
Class II
·Terminated·LivaNova USA·May 30, 2018
PREMIUM O.B. PACK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
FDA Enforcement
Class II
·Terminated·Edwards Lifesciences, LLC·September 18, 2013