19 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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