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MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A

FDA 510(k)
FDA Class 2 ·Cardiovascular

FALLS CREEK

FDA UDI
FGX INTERNATIONAL INC.·00193033489321·

LORENZ FIDUCAIL SCREW

FDA 510(k)
FDA Class 2 ·Neurology

ZINC PHOSPHATE CEMENT

FDA 510(k)
FDA Class 2 ·Dental

0009613348-2024-013427

FDA Adverse Event
Injury ·INSTITUT STRAUMANN AG·Product code DZE·October 8, 2024

PROFEMUR(R) COCR NECK

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·March 20, 2013

ISERT ASPHERIC INTRAOULAR LENS

FDA Adverse Event
Malfunction ·HOYA SURGICAL OPTICS INC.·Product code HQL·February 3, 2011

SPRINT FIDELIS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·March 10, 2008

IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 11.5MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·April 26, 2024

IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code DZE·December 19, 2019

IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·August 7, 2019

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

FDA Adverse Event
Malfunction ·ZIMVIE US CORP LLC·Product code DZE·May 29, 2026

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·February 23, 2022

IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code DZE·October 11, 2022

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

FDA Adverse Event
Injury ·ZIMVIE US CORP LLC·Product code DZE·May 20, 2026

IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

FDA Adverse Event
Injury ·ZIMVIE US CORP LLC·Product code DZE·May 12, 2026

IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

FDA Adverse Event
Injury ·ZIMVIE US CORP LLC·Product code DZE·May 12, 2026

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

FDA Adverse Event
Injury ·ZIMVIE US CORP LLC·Product code DZE·March 25, 2026

IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM

FDA Adverse Event
Injury ·ZIMVIE US CORP LLC·Product code DZE·April 28, 2026

IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

FDA Adverse Event
Malfunction ·ZIMMER DENTAL·Product code DZE·October 16, 2018