10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NATRELLE INSPIRA Single Use Sizers for Gel Implants
FDA 510(k)
FDA Unclassified
·Unknown
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114209·SILICONE TIP CANNULA 27GA (PK/10)
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 9, 2022
S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
FDA 510(k)
FDA Class 2
·Radiology
BIOPATCH ANTIMICROBIAL DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
ENDOVIVE SAFETY PEG KITS PULL METHOD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNT·October 17, 2008
STERLING¿
FDA Adverse Event
Malfunction
·Product code DQY·August 11, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 2, 2013
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