16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FILTERSET 0.22, I.V. PUMP
FDA 510(k)
FDA Class 2
·General Hospital
BD ALARIS¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 24, 2021
UNSPECIFIED BD INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 22, 2022
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192961·Femoral Locating Device Bushing 8 deg
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189626·6+ FEMUR / 7 TIBIA TRIALS INSTRUMENT PAN
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690189619·AK3 6+ Femur/7 Tibia Instrument pan insert
SurgyCut
FDA UDI
U.S. SURGITECH INC.·00810014631226·SurgyCut L - Wire Hand Control Electrode, 5mm/35cm
discovery®
FDA UDI
DENTAURUM GmbH & Co.KG·J011790108000·discovery® Bracket with hook, - 11° Torque, + 7...
SurgyCut
FDA UDI
U.S. SURGITECH INC.·00810014632247·SurgyCut L - Wire Hand Control Electrode, 5mm/45cm
PROSTHESIS, TOTAL HIP-TEST CUP
FDA 510(k)
FDA Class 2
·Orthopedic
HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
GORE TAG THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·January 6, 2012
CAPSUREFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 5, 2014
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·August 2, 2010
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024