13 results
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22ms
·
Sources: EU EUDAMED, US FDA
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
SpheRx
FDA UDI
Nuvasive, Inc.·00887517450197·Lock Screw Starter Guide/Counter Torque
Vivid ZirDisc Wieland System
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724Q2500361·98mmx28mm SHT (Super Translucent)
Waxed Dental Floss
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063755666·Waxed Dental Floss, mint, 12 yds - sample size,...
FIA Biomed Precisa Blood Glucose Test Strip
FDA UDI
HMD BIOMEDICAL INC.·04711200724219·FIA Biomed Precisa Blood Glucose Test Strip(F50SL)
FES CYCLE ERGOMETER, MODEL RT300-S
FDA 510(k)
FDA Class 2
·Neurology
Blue Mountain Cervical Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G6 GLUCOSE PROGRAM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 8, 2025
BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·July 10, 2019
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 14, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011
ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·July 26, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013