16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
POLINELLI
FDA UDI
FGX INTERNATIONAL INC.·00193033333396·
POLINELLI
FDA UDI
FGX INTERNATIONAL INC.·00193033333266·
POLINELLI
FDA UDI
FGX INTERNATIONAL INC.·00193033333273·
POLINELLI
FDA UDI
FGX INTERNATIONAL INC.·00193033333259·
POLINELLI
FDA UDI
FGX INTERNATIONAL INC.·00193033333242·
CHEMWELL, MODEL 2900
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
11MM/130 DEG TI CANN TROCH FIXATION NAIL 360MM/LEFT
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·February 11, 2016
ENDOPATH ETS FLEX
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 23, 1997
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 19, 2013
MINI-CAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·March 9, 2011
COZMO INSULIN PUMP
FDA Adverse Event
Injury
·SMITHS MEDICAL MD (FORMERLY DELTEC, INC)·Product code LZG·March 10, 2008
WALLFLEX COLONIC
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 31, 2024
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 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