13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MOBIS II ST SPINAL IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131271372·NERA PRO, KIT 10 WL OMNI 85 BE
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037305·Unitek(TM) Bicuspid Band General Purpose Wide L...
K2M General Instruments
FDA UDI
VB Spine LLC·10888857581005·Split Tube Retractor Ø12x70 mm
BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASPIRATION PUMP, MODEL IMD-020
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2025
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL NEUROMODULATION·Product code LGW·May 24, 2013
OT VERIO2 METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 4, 2014
S-ROM M HEAD 36MM +3
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 8, 2011
LAPIPLASTY SYSTEM 2
FDA Adverse Event
Injury
·TREACE MEDICAL CONCEPTS, INC.·Product code HWC·August 11, 2020
MX8000 Dual v.EXP CT scanner using Version 2.5 software.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·March 11, 2005
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025