13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
FDA 510(k)
FDA Class 2
·Dental
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091033065·Baltic Denture System BDLoad ↓ Mn6 PLSEum2DFm D...
SlimLine®
FDA UDI
ZIMMER SPINE, INC.·00889024403710·
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319701324·Meyhoefer Chalazion Curette 5" (12.5cm), size 4...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330150·Coronal Bender, Left
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330050·Vise Grip, Large, 5.5mm
CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SEEDNET, MODEL EP6T5, EP5E5
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 1, 2013
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 28, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014
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