14 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White); Dark Violet Blue (DVBU); Dark Blue (DKBU)
FDA 510(k)
FDA Class 1
·General Hospital
BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304254282·
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK
FDA 510(k)
FDA Class 2
·Immunology
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PENUMA IMPLANT
FDA Adverse Event
Injury
·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019
BD ANGIOCATH AUTOGAURD IV CATHETER
FDA Adverse Event
Other
·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code FOZ·May 19, 2009
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
EBI SPINELINK SPINAL FIXATION SYSTEM
FDA Adverse Event
EBI, L.P.·Product code NKB·September 18, 2008
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025