15 results · 20ms · Sources: EU EUDAMED, US FDA

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OSTEOGEN SBRG

FDA 510(k)
FDA Class 2 ·Dental

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091033098·Baltic Denture System BDLoad Sw7 PLSEbm6DFs D4 ...

INSTANT-VIEW Morphine/Opiates (300) Urine Dip-Strip Test

FDA UDI
ALFA SCIENTIFIC DESIGNS, INC.·10796918000542·INSTANT-VIEW Morphine/Opiates (300) Urine Dip-S...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330080·Rocker, Hinged, Locking

ALPHATEC

FDA Adverse Event
ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004

KIMAX REMOTE VIEWING STATION

FDA 510(k)
FDA Class 2 ·Radiology

ACCESS ULTRASENSITIVE HGH CALIBRATORS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

RAD-5V HANDHELD

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·July 10, 2015

PARIETEX

FDA Adverse Event
Injury ·Product code OTP·January 5, 2015

RAD-5 PULSE OXIMETER

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 13, 2018

ULTRACISION HARMONIC ACE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 3, 2013

LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

FDA Adverse Event
Malfunction ·PHYSIO-CONTROL, INC.·Product code MKJ·February 28, 2011

LEAD MODEL 302

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·April 22, 2008

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024