24 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMS Cementless Stem
FDA 510(k)
FDA Class 2
·Orthopedic
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·September 12, 2022
CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 10, 2024
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446823490·SPECIAL, EMPOWR REVISION FEMORAL TRIAL ADAPTER,...
HHM
FDA UDI
Oticon A/S·05707131357144·G500 SC, MINIRITE R LI-ION 2.4G C093 HHM
Dornier MedTech
FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116023493·THULIO LL-R TM 1000µM 3M PERF. FIBER 3ST 10X USE
TOTAL HIP FEMORAL HEAD - 12/14 TAPER
FDA 510(k)
FDA Class 2
·Orthopedic
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AQUACEL SURGICAL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAC·September 22, 2023
AQUACEL SURGICAL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAC·September 22, 2023
AQUACEL SURGICAL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAC·September 22, 2023
AQUACEL SURGICAL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAC·September 22, 2023
AQUACEL SURGICAL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAC·September 22, 2023
AQUACEL SURGICAL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAC·September 22, 2023
AQUACEL SURGICAL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAC·September 22, 2023
AQUACEL SURGICAL
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code NAC·September 22, 2023
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 27, 2014
PCS2
FDA Adverse Event
Malfunction
·HAEMONETICS CORP.·Product code CAC·August 4, 2011
SYNCHROMED
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·July 2, 2013
ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015