14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
ZAVATION
FDA UDI
Zavation LLC·00842166117051·Polyaxial Screw 3.5mm x 10mm
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106440·BISHOP-HARMON FORCEPS STANDARD
LEVEL ONE NEURO
FDA UDI
KLS-Martin L.P.·00888118093462·PLATE, FIXATION, Q BONE FLAP, 3.0 MM STOP, NEUR...
IR WIRELESS FOOT SWITCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Powder Free Polychloroprene Examination Glove Green
FDA 510(k)
FDA Class 1
·General Hospital
MODULAR POROUS LATERALIZED REDUCED DISTAL TAPERLOC FEMORAL
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·September 29, 2016
SPRINT
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LWS·February 9, 2013
ANEURX AAADVANTAGE STENT GRAFT SYSTEM- HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·January 5, 2011
UNKNOWN DEPUY DURALOC LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWA·July 23, 2014
M2A-MAGNUM MODULAR HEAD SZ 52MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·September 30, 2016
M2A-MAGNUM PF CUP
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 20, 2017
Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017