24 results
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35ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AMSure® Single Use Saline Topical Solution
FDA 510(k)
FDA Unclassified
·Unknown
EZ-Stick
FDA UDI
COMPASS HEALTH BRANDS CORP.·00092237902332·2"x3.5" Cloth
LIPOSUCTION CANNULA
FDA UDI
SONTEC INSTRUMENTS, INC.·B0992011380·LIPOSUCTION CANNULA WITH THREE HOLES STRAIGHT
EZ-Stick
FDA UDI
COMPASS HEALTH BRANDS CORP.·10850958007746·2"x3.5" Cloth, Case of 10
EZ-Stick
FDA UDI
COMPASS HEALTH BRANDS CORP.·00850958007749·2"x3.5" Cloth
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306805691·McKissock Breast Caliper, 38mm
SLEEPSCREEN/APNOESCREEN CARDIO
FDA 510(k)
FDA Class 2
·Anesthesiology
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
FDA 510(k)
FDA Class 2
·Cardiovascular
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
LEAD MODEL UNKNOWN
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·November 30, 2011
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·November 30, 2011
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·November 30, 2011
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 27, 2014
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 29, 2011
RUBICON? 14
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·July 2, 2013
PROLENE HERNIA SYSTEM UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·March 15, 2019
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·July 17, 2011
HENRY SCHEIN SOFTLINE CHAIRSIDE RELINE KIT
FDA Adverse Event
Other
·SEPTODONT CONFI-DENTAL DIVISION·Product code EBC·June 15, 2011
KINETRA
FDA Adverse Event
Death
·MEDTRONIC NEUROMODULATION·Product code MRU·May 20, 2016