32 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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VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles
FDA 510(k)
FDA Class 2
·General Hospital
Polysorb
FDA UDI
Covidien LP·20884521126777·Absorbable Single Stitch Reload
STAINLESS STEEL FEMORAL NAILING SYSTEM
FDA UDI
ORTHOFIX SRL·18032568033557·INTERNAL TEMPLATE LOCK. SCREW FEMORAL NAIL
RUSCH
FDA UDI
TELEFLEX INCORPORATED·04026704319572·SLICK SET CUFFED STERILE
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889981168735·CORTICAL SHANK, Cannulated, 7.0 X 70
Mariner Cortical
FDA UDI
Seaspine Orthopedics Corporation·10889987168739·CORTICAL SHANK, Cannulated, 7.0 X 70
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
FDA Recall
Open, Classified
·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021
RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095
FDA Enforcement
Class II
·Completed·Teleflex Medical Europe Ltd·August 25, 2021
Ø3.5mm x 70mm Precontoured Cervical Rods
FDA UDI
XENCO MEDICAL LLC·B064XM21700701·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197535526·Mayo Abdominal Retractor
275mm ...
ASCENT DENTAL CLEANSER
FDA 510(k)
FDA Class 2
·Dental
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Ø3.5mm X 70mm PRECONTOURED CERVICAL RODS
FDA UDI
XENCO MEDICAL LLC·B064XMPH21700702·
HANAROSTENT® Esophagus (CCC)
FDA UDI
M.I.Tech Co., Ltd.·08806367004222·Full Covered metallic esophagus stent
HANAROSTENT® Esophagus (CCC)
FDA UDI
M.I.Tech Co., Ltd.·08806367024824·Full Covered metallic esophagus stent
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 2, 2025
GIA UNIVERSAL
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDW·July 13, 2011
ENDO STITCH 10MM SUTURING DEVICE
FDA Adverse Event
Injury
·COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES·Product code KOG·June 4, 2013
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008
COBALT BONE CEMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LOD·September 13, 2017