12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INSTEAD INTIMATE LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496033776·PERSONALITY 140 SHEER, SIZE 2XXL, CAMEL, GRADUA...
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033776·Baltic Denture System BDLoad BDLoad Mn7 PLSEbi...
MICROTARGETING DRIVE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
MICROJET MODEL # CD4 AND CD4/20
FDA 510(k)
FDA Class 2
·General Hospital
PLUM 4-PORT 15 FLTR 2CLV PE LINE 216CM
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·June 27, 2013
ATLANTIS? SR PRO²
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code DQO·April 3, 2013
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·March 17, 2011
MYNX VASCULAR CLOSURE DEVICE
FDA Adverse Event
Injury
·ACCESSCLOSURE, INC.·Product code MGB·April 25, 2008
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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