9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTCO TAB ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
CTS-415
FDA 510(k)
FDA Class 2
·Radiology
ALBUMIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 30, 2025
SIGMA PS CEM FEM SZ4 R
FDA Adverse Event
Injury
·9616671 DEPUY (IRELAND)·Product code NJL·May 6, 2013
UNIV-BATTERY CHARGER F/SYNTHES BATT 4 CH
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MOQ·September 16, 2014
LS PLUM PRIMARREGULAR PUMP SET 5000 - XL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD·Product code FRN·April 15, 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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018