30 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERIFY Spore Test Strip for S40 Sterilant Concentrate
FDA 510(k)
FDA Class 2
·General Hospital
BD BBL™ DrySlide™ Oxidase
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902317464·BD BBL™ DrySlide™ Oxidase
Tempus Pro Patient Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
Pocket Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
BD BBL¿ DRYSLIDE¿ OXIDASE
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code JTO·October 17, 2023
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·October 14, 2014
INFUSO.R.
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.8010379·Product code KWA·July 17, 2013
BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code JTO·April 12, 0013
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·November 3, 2025
BBL DrySlide Oxidase Kit, catalog number 231746 Product Usage: Presumptive diagnostic aid for gram-negative bacteria.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·June 5, 2013
TRUENESS
FDA Adverse Event
Injury
·SINOCARE INC·Product code NBW·October 15, 2025
SUMMIT DUOFIX TAP SZ4 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·January 7, 2013
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·January 7, 2013
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·January 7, 2013
PINN SECTOR HA ACET CUP 52MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 7, 2013
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC.·Product code NBW·November 28, 2025
TRUENESS
FDA Adverse Event
Injury
·SINOCARE INC ADDRESS LINE 1 NO.265 GUYUAN·Product code NBW·October 20, 2025
TRUENESS
FDA Adverse Event
Malfunction
·SINOCARE INC·Product code NBW·May 29, 2026