16 results · 21ms · Sources: EU EUDAMED, 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