19 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BriefCase
FDA 510(k)
FDA Class 2
·Radiology
BD BBL™ GC II Agar with IsoVitaleX™ Enrichment
FDA UDI
BECTON, DICKINSON AND COMPANY·10382902212406·BD BBL™ GC II Agar with IsoVitaleX™ Enrichment,...
InCompass®
FDA UDI
ZIMMER SPINE, INC.·00889024400528·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111347696·STEVENS TEN DEL STR 4 1/2" S/S
Vu aPod™ - L
FDA UDI
Seaspine Orthopedics Corporation·10889981046477·LATERAL TRIAL, WIDE, STANDARD, 12mm X 23mm X 40mm
REPROCESSED ENDOSCOPIC TROCARS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 30, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
CAPTURE-R READY-ID
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·January 22, 2019
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
CBCII BLOOD CONSERVATION KIT W/3/16 INCH ROUND PVC
FDA Adverse Event
Injury
·STRYKER INSTRUMENTS PUERTO RICO·Product code CAC·August 16, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 11, 2013
BD¿ CHOCOLATE AGAR (GC II AGAR WITH ISOVITALEX¿)
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·July 15, 2022
BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSO·February 2, 2022
PLATE CHOCO GC AGAR W/ISOVITALEX 90MM
FDA Adverse Event
Malfunction
·BECTON DICKINSON GMBH·Product code JSO·June 1, 2021
BD BBL¿ GC II AGAR WITH ISOVITALEX¿ ENRICHMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code JSO·June 8, 2021
BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018
dS Breast 7ch 3.0T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024