19 results · 23ms · Sources: EU EUDAMED, US FDA

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TRANSDUCER, S8-3T MICRO TEE

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·August 8, 2014

HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

TRANSDUCER, S8-3T MICRO TEE

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 28, 2014

TRANSDUCER, S8 3T MICRO TEE

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC·Product code IYO·June 27, 2014

TRANSDUCER S8-3T MICRO TEE

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·January 24, 2014

HDI 5000 ULTRASOUND STANDARD SYSTEM

FDA Adverse Event
Malfunction ·PHILIPS ULTRASOUND, INC.·Product code IYO·March 30, 2012

NA

FDA UDI
Conmed Corporation·10653405005650·YANKAUER Suction Instrument without Control Ven...

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091034003·Baltic Denture System BDLoad BDLoad ↓ Mm6 PLSEu...

NIFometer

FDA UDI
MERCURY ENTERPRISES, INC.·10641043340035·

4.0 X 30MM OUTER SLEEVE

FDA UDI
Osteocentric Technologies, Inc.·00816950029738·4.0 X 30MM OUTER SLEEVE

GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT

FDA 510(k)
FDA Class 2 ·Ophthalmic

PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30

FDA 510(k)
FDA Class 2 ·Orthopedic

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 6, 2019

RESERVOIR 3ML

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 3, 2013

UNKNOWN DEPUY SIZE 2 CURVED INSERT

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 17, 2011

BIOCOR SUPRA TISSUE VALVE

FDA Adverse Event
Injury ·ST JUDE MEDICAL BRASIL LTDA·Product code LWR·April 25, 2008

TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003. Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).

FDA Recall
Terminated ·Radiometer America Inc·Product code LKD·September 27, 2011

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