15 results · 21ms · Sources: EU EUDAMED, US FDA

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DISTAL ACCESS TORQUE DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613017774·K-Wire, Double Ended, Trocar Point, Diameter Si...

Batrik Pin Guard\.054"\Dark Red

FDA UDI
Batrik Medical Manufacturing Inc·00690521012851·Pin Guards, 0.054" (1.40 mm), Dark Red, Non-ste...

RECAP/MAGNUM HIP INSTRUMENTATION

FDA UDI
Biomet Uk Ltd·05019279108237·

Batrik Pin-Kaps

FDA UDI
Batrik Medical Manufacturing Inc·00690521014145·Pin-Kaps, Sterile, Dark Red, 0.054" / 1.40 mm

Batrik Pin Guard\.054"\Dark Red w/sleeve

FDA UDI
Batrik Medical Manufacturing Inc·00690521014541·Pin Guards, 0.054" (1.40 mm), Dark Red, Non-ste...

Kyocera Medical Technologies, Inc.

FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523106400·Porous Acetabular Cup System - Hemispherical Sh...

MEDLINE STRIDER MAXI 3

FDA 510(k)
FDA Class 2 ·Physical Medicine

ROMIAPEX MODEL A-15

FDA 510(k)
FDA Unclassified ·Unknown

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2024

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013

ACCU-CHEK SPIRIT COMBO

FDA Adverse Event
Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 16, 2011

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·August 29, 2008

MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 28, 2019

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026