24 results
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19ms
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Sources: EU EUDAMED, US FDA
INPECTRA STO2 SPOT CHECK
FDA 510(k)
FDA Class 2
·Cardiovascular
AGXO
FDA UDI
Oticon A/S·05707131164834·K140, BTE 13 CNB AGXO
Nail Splitting Scissors
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896102408·Ingrown Nail Splitting Scissor Straight One Ser...
SOFT PLUG ABSORBABLE PLUG-SA
FDA 510(k)
FDA Unclassified
·Unknown
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
FDA 510(k)
FDA Class 2
·Radiology
T-Plus PEEK IBF System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468088569·INTERBODY FUSION DEVICE
T-PLUS™* PEEK VBR/IBF SYSTEM
FDA UDI
Pioneer Surgical Technology, Inc.·00846468032753·T-Plus, 10X36X13
T-PLUS™* PEEK VBR/IBF SYSTEM
FDA UDI
Pioneer Surgical Technology, Inc.·00846468032760·T-Plus, 10X36X13, 6 DEG LORDOTIC
T-Plus PEEK IBF System
FDA UDI
Pioneer Surgical Technology, Inc.·00846468088644·INTERBODY FUSION DEVICE
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246786668·
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246786736·
Fortilink Cages with TiPlus Technology
FDA UDI
Baat Medical Products B.V.·08720246786576·
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 9, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 19, 2014
N/A
FDA Adverse Event
Malfunction
·ASCENT·Product code NLQ·May 26, 2011
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 18, 2018
Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral Body Replacement System to ensure stability of the spine and adequate compression of the implant.
FDA Enforcement
Class II
·Terminated·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·July 8, 2015
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
FDA Enforcement
Class III
·Terminated·Illumina Inc·December 31, 2014
Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-1036-13-6 UDI (01)00846468032760(17)200115(10)202582. These products are part of the lnterbody Fusion Vertebral Body Replacement System to ensure stability of the spine and adequate compression of the implant.
FDA Recall
Terminated
·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code MAX·May 21, 2015
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012