12 results
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24ms
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Sources: EU EUDAMED, US FDA
SOEHENDRA LITHOTRIPSY SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Venner™ PneuX P.Y.™ TT MRI
FDA UDI
VENNER MEDICAL (SINGAPORE) PTE. LTD.·08885009190820·The Venner™ PneuX P.Y.™ Tracheostomy tube is de...
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515227743·House Mini Ear Fcps, very fine, .6x1mm cups
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221111586·3M™ Victory Series™ First Molar Bands, 902-170,...
MODEL 9000 PEDIATRIC WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
STA LIATEST FREE PS
FDA 510(k)
FDA Class 2
·Hematology
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·September 1, 2021
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 6, 2014
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·November 15, 2010
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Death
·EV3 NEUROVASCULAR·Product code OUT·January 8, 2013
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·April 27, 2021
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