14 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
FDA 510(k)
FDA Class 2
·Orthopedic
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032197·Baltic Denture System BDLoad ↓ Lw6 PLSEum4DFl B...
OPTIMUM
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975066961·Optimum® HP Carbide Bur Straight/Flat End Cross...
CARTOUCH
FDA 510(k)
FDA Class 2
·Cardiovascular
POWERHEART CARDIAC RHYTHM MODULE
FDA 510(k)
FDA Class 3
·Cardiovascular
Quick-Core
FDA UDI
COOK INCORPORATED·00827002106314·Coaxial Quick-Core, Needle Biopsy Set
HIRES 90K ADVANTAGE IMPLANT
FDA Adverse Event
Injury
·ADVANCED BIONICS LLC·Product code MCM·March 29, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 29, 2011
BRAVO
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code FFT·April 21, 2008
GORE® VIATORR® TIPS ENDOPROSTHESIS
FDA Adverse Event
Death
·W. L. GORE & ASSOCIATES, INC.·Product code MIR·February 15, 2023
GORE® VIATORR® TIPS ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code MIR·February 15, 2023
The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022