20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LANX ANTERIOR CERVIAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001960·Cervical Collar
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911040401·CUBE PESSARY W/ DRAINAGE HOLES #1
BiomarC®
FDA UDI
Carbon Medical Technologies, Inc.·00858015005103·Preloaded Carbon Tissue Marker, Needle Tip Deli...
VIDAS® T4
FDA UDI
BIOMERIEUX SA·03573026156916·The VIDAS ® T4 (T4) assay is intended for use o...
ICU Medical
FDA UDI
ICU MEDICAL, INC.·00840619045371·TriOx™ SO2 Umbilical Artery Catheter U440, 4F, ...
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319700020·Miniature Blade Handle w/ self-locking chuck, 3...
Toilet Support Arms
FDA UDI
Ropox A/S·05707581014741·
VAPOTHERM, MODEL 2000I
FDA 510(k)
FDA Class 2
·Anesthesiology
TRI-PLEX ADAPTER
FDA 510(k)
FDA Class 2
·Anesthesiology
InnovaMatrix AC
FDA UDI
Triad Life Sciences, Inc.·00850002643169·4cm x 4cm Placental ECM
Phonak
FDA UDI
Sonova AG·07613275614174·Phonak Naída B90-UP (beige)
InnovaMatrix FS
FDA UDI
Triad Life Sciences, Inc.·00850002643343·4cm x 4cm Fenestrated Placental ECM
PRECICE STRYDE SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE SPECIALIZED ORTHOPEDICS, INC.·Product code PGN·August 17, 2021
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·April 8, 2013
MODULAR ANALYZER
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 7, 2008
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 5, 2011
VIDAS FT4 60 TEST
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code KLI·July 14, 2021
VIDAS T4 60 TESTS
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code KLI·April 23, 2021
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024