12 results
·
31ms
·
Sources: EU EUDAMED, US FDA
TRIGLYCERIDES FOR SMA AND AAII
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NUPRO® Prophylaxis Paste with Fluoride
FDA UDI
DENTSPLY INTERNATIONAL INC.·D0038012261·NUPRO® Prophy Paste, Grape, Medium, Single Box ...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450179369·
SIMPACT IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Injury
·DATASCOPE CORP.·Product code DSP·October 10, 1998
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·October 10, 1998
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 8, 2014
ASR ACETABULAR CUPS 62
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012
UNKNOWN DEPUY CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·August 11, 2010
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 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