14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
FDA 510(k)
FDA Class 2
·Neurology
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750003440·65 V2 PETITE 22ID STRGT W/HG
Plateau C
FDA UDI
Life Spine, Inc.·00190837093457·
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
FDA 510(k)
FDA Class 2
·Hematology
PAGEWRITER TC 20 CARDIOGRAPH
FDA Adverse Event
Malfunction
·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
LOCKING CAP
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KTT·October 19, 2012
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 15, 2013
45 CM 5FR. D/L GROSHONG NXT BASIC WITH MI AND TLS
FDA Adverse Event
Injury
·C. R. BARD, INC. (BASD)·Product code FOZ·June 1, 2011
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021