13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033703·Baltic Denture System BDLoad BDLoad ↓ Mw7 PLSEu...
MAMMOTOME EX
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 7, 2006
SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175M
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TAUT-INSUFFLATION NEEDLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JKA·May 2, 2018
CHLORAPREP ONE STEP HI-LITE ORANGE
FDA Adverse Event
Malfunction
·CAREFUSION 213, LLC 0113·Product code KXG·July 28, 2021
MAVERICK²¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·April 3, 2013
VISTA BASIC SAFETY INFUSION SYSTEM
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL, INC.·Product code FRN·February 11, 2011
IMPLANTIUM
FDA Adverse Event
Injury
·DENTIUM·Product code DZE·April 25, 2008
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024