14 results
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20ms
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Sources: EU EUDAMED, US FDA
DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
FDA 510(k)
FDA Class 2
·Immunology
ADVIA® Chemistry AMY Amylase Reagents
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414517452·Amylase - ADVIA Chem. - RGT - 7x355 tests
PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
FDA 510(k)
FDA Class 1
·Microbiology
BCI ADVISOR VITAL SIGNS MONITOR (9200)
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 2, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 16, 2011
ENDEAVOR RX
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·April 18, 2008
ENDOPATH ETS FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 23, 1997
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·May 13, 2016
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KWP·May 13, 2016
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018