14 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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QUATTRO PORCELAIN SYSTEM
FDA 510(k)
FDA Class 2
·Dental
LEONE SPA
FDA UDI
LEONE SPA·08033707065739·INTRAORAL ELASTICS 6,5 oz 3/16" green
LEONE SPA
FDA UDI
LEONE SPA·08033707065746·INTRAORAL ELASTICS 6,5 oz 1/4" red
LEONE SPA
FDA UDI
LEONE SPA·08033707065753·INTRAORAL ELASTICS 6,5 oz 5/16" blue
WMT MODULAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
FLEXICAST PRIME
FDA 510(k)
FDA Class 2
·Dental
General Instrument
FDA UDI
ALPHATEC SPINE, INC.·00840180507476·Curette Cup, Right-Angled, Straight, Serrated, ...
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 3, 2013
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·September 16, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·May 17, 2011
Endopath Probe Plus II, Hand-Controlled PistolGrip Handle, Product Code EPH02.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code GCJ·April 20, 2006
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.
FDA Enforcement
Class II
·Terminated·Greatbatch Medical·June 8, 2016
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