12 results · 29ms · Sources: EU EUDAMED, US FDA

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FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440

FDA 510(k)
FDA Class 2 ·Ophthalmic

SECURCUT ASPIRATION BIOPSY NEEDLE

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

FDA 510(k)
FDA Class 2 ·Ophthalmic

PEN NDL 31GA 8MM 100 BX 1200 USA

FDA Adverse Event
Malfunction ·EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND·Product code FMI·February 18, 2025

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 3, 2013

HEARTSTART XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 10, 2014

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 3, 2011

HI-TORQUE WHISPER MS GUIDE WIRE

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code DQX·March 6, 2017

NAIL, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code JDS·July 25, 2016

NAIL, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code JDS·July 25, 2016

30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile devices intended for the infusion and withdrawal of fluids.

FDA Enforcement
Class II ·Terminated·ICU Medical, Inc.·April 6, 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