10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM
FDA 510(k)
FDA Class 2
·Neurology
CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD BBL SENSI-DISC OXACILLIN - 1 G
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code JTN·July 2, 2021
BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ CLOSURE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 27, 2017
DISTAL TARGETING DEVICE GAMMA3 DISTAL TARGETING R1.5
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·May 3, 2013
CER BIOLOXD OPTION HD 36MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·September 16, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 2, 2011
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015