11 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HOFFMANN II PELVIC CLAMP
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033145·Baltic Denture System BDLoad BDLoad ↓ Mm6 PLSEu...
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·August 30, 2021
ORIGEN BLADDER HOLDER
FDA 510(k)
FDA Class 2
·Cardiovascular
WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR.
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 1, 2013
TOTALCARE BARIATRIC
FDA Adverse Event
Malfunction
·HILL-ROM INC·Product code FNL·February 28, 2011
ALLTHREAD LACTOSORB ANCHOR
FDA Adverse Event
Malfunction
·BIOMET SPORTS MEDICINE/BIOMET·Product code JDR·April 22, 2008
Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class II
·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015
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