23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SpiroThor
FDA 510(k)
FDA Class 2
·Anesthesiology
AGXO
FDA UDI
Oticon A/S·05707131284808·H150V2, MINIRITE 312 WL CBE AGXO
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690111634·Modular Stem 13mm x 75mm
S-LIFT®
FDA UDI
SPINEFRONTIER, INC.·00190361038153·TRIAL SHAFT, ANGLED, 22MM WIDE, 14MM
S-LIFT®
FDA UDI
SPINEFRONTIER, INC.·00190361038641·TRIAL, ANGLED, 22MM WIDE, 16MM
S-LIFT®
FDA UDI
SPINEFRONTIER, INC.·00190361038092·TRIAL SHAFT, ANGLED, 22MM WIDE, 10MM
S-LIFT®
FDA UDI
SPINEFRONTIER, INC.·00190361038122·TRIAL SHAFT, ANGLED, 22MM WIDE, 12MM
S-LIFT®
FDA UDI
SPINEFRONTIER, INC.·00190361038061·TRIAL SHAFT, ANGLED, 22MM WIDE, 8MM
Trial Cage 20deg 16S
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215066680·
SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES
FDA 510(k)
FDA Class 2
·Orthopedic
TEMPTOUCH DERMAL THERMOMETER
FDA 510(k)
FDA Class 2
·General Hospital
Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243
FDA Enforcement
Class II
·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 7, 2014
ALARIS SE PUMP ADMIN SET
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FPA·May 1, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
A7 ANESTHESIA SYSTEM
FDA Adverse Event
Malfunction
·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025
AMBIENT SUPER TURBOVAC 90 IFS
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code GEI·July 9, 2017
HEMOSIL HIT-AB(PF4-H)
FDA Adverse Event
Malfunction
·INSTRUMENTATION LABORATORY CO.·Product code LCO·March 13, 2025