16 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOCENTREX CARDIAC PANEL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033155·Baltic Denture System BDLoad BDLoad ↓ Mm7 PLSEu...
DADE THROMBOPLASTIN C PLUS
FDA 510(k)
FDA Class 2
·Hematology
VERTEBRAL BODY REPLACEMENT
FDA 510(k)
FDA Class 2
·Orthopedic
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·August 21, 2024
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 1, 2013
840
FDA Adverse Event
Malfunction
·COVIDIEN PURITAN BENNETT·Product code CBK·March 9, 2011
WECK HOL L CLIPS
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code FZP·April 23, 2008
LARGE EX-FIX COMBINATION CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 13, 2018
LARGE EX-FIX 11MM CRBN FBR ROD 250MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018
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