32 results · 21ms · Sources: EU EUDAMED, 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