19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EPIX ELECTROSURGICAL PROBE SPATULA TIP, EPIX ELECTROSURGICAL PROBE L-HOOK TIP, EPIX ELECTROSURGICAL PROBE J-HOOK TIP, RE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoRoent
FDA UDI
Nuvasive, Inc.·00887517565280·CoRoent Ant TLIF PEEK, 13x12x30mm 0°
RC Multi-base Abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600306351·
AGXO
FDA UDI
Oticon A/S·05707131257963·H160, MINIBTE 312 WL 85 SIL AGXO
TROUTMAN-KATZIN CORNEAL TRANSPLANT SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896014336·TROUTMAN-KATZIN CORNEAL TRANSPLANT SCISSORS STR...
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102367·BARRAQUER IRIS SPATULA 0.5MM
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993371624·ELVAREX 1/KNEE HIGH/SLANT-CLOSED TOE/DOTTED 5 C...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702555059·ELVAREX 3/KNEE HIGH/SLANT-CLOSED TOE/DOTTED 2,5...
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 25, 2002
DEL VECCHIO RE-INJECTION
FDA UDI
The Wells Johnson Company·B458201323000·Cannula, Micro, Del Vecchio Re-Injection, speci...
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 7, 2023
ACCOLADE-J HIP STEM SERIES
FDA 510(k)
FDA Class 2
·Orthopedic
KIMGUARD SMART-FOLD* STERILIZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
3I T3® TAPERED IMPLANT 4/3 X 11.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·May 20, 2025
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 29, 2013
ADJ PIN COLLET 2.0-3.2MM
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 11, 2011
TRULIANT TIB IMP PS INSERT SZ 5 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 21, 2023
Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Size 2.5 Catalog # 6021-4535 Accolade (127 DEG) Size 4.5 K994366; k023105; K032300 Manufactured by " Stryker Ireland, Carrigtwohill Industrial Estate Carrington County Cork, Ireland The subject hip stem is a single-use device intended for the reconstruction of the head and neck of the femoral joint. This hip stem is intended for primary reconstruction of the proximal femur or revision total hip arthroplasty.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code ISL·March 1, 2011