18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
FDA 510(k)
FDA Class 2
·Ophthalmic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450293805·
Electric Wheelchair [Models: JRWD6010/JRWD6012]
FDA 510(k)
FDA Class 2
·Physical Medicine
CONVERGE ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TPRLC 133 MP TYPE1 PPS SO 15.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWZ·August 13, 2021
GSTAR AC PWR VC
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·May 14, 2014
ON-Q PAIN PUMP
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·January 8, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 2, 2010
TPRLC 133 MP TYPE1 PPS SO 15.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWZ·August 13, 2021
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
TPRLC 133 MP TYPE1 PPS SO 15.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWZ·August 13, 2021
CLICKX PEDICSCR Ø6.2 L50 TAN DBLUE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·October 15, 2025
GENESIS UNI KNEE FEMORAL COMPONENT COCR
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code HSX·May 23, 2025
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015