38 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE
FDA 510(k)
FDA Class 2
·General Hospital
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317300447·
AIM™FEMORAL NAIL
FDA UDI
Biomet Orthopedics, LLC·00887868003448·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450160053·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112440·Awl Tap, 6.5 mm, Fixed Sleeve
MaxFuse VBR, 10 (D) x 12 (W) x 28 (H)
FDA UDI
Pioneer Surgical Technology, Inc.·00846468055103·10 (D) x 12 (W) x 28 (H)
BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D
FDA 510(k)
FDA Class 2
·Cardiovascular
ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
VASO VIEW HEMOPRO
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 8, 2019
INFAST SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 20, 2010
TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC
FDA Adverse Event
Injury
·COOK INC·Product code LJS·January 18, 2017
QUADRA ASSURA CRT-D
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 9, 2013
INSYNC SENTRY
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code NIK·September 19, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011
VASOVIEW HEMOPRO 2
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·April 13, 2019
TURBO-JECT POWER INJECTABLE
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·July 3, 2018
INFAST SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 20, 2010
INFAST SLING SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·October 20, 2010
HEMOPRO 2 ADAPTOR
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR LLC·Product code GEI·February 21, 2020
TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·August 24, 2017