26 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT
FDA 510(k)
FDA Class 2
·Immunology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743571·LEVAMED ANKLE SUPPORT SILVER VI
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023994·PADDLE SPREADER, 16MM
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102060·Shaver, Open, 6mm
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023895·PADDLE SPREADER, 6MM
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102160·Shaver, Open 16mm
Bellinger
FDA UDI
Bellinger A/S·05712544157953·Spectacle frame
SYNERGY VLS CAP NUT MODELS 2206, 6102
FDA 510(k)
FDA Class 2
·Orthopedic
RIZA BAND STRETCHER (RBS)-60000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
M-SERIES DC POWER SUPPLY
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·May 25, 2012
REMSTAR AUTO M SERIES
FDA Adverse Event
Injury
·RESPIRONICS, INC.·Product code BZD·April 14, 2024
CA090, DIRECT DRIVE LCA 3/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code FZP·October 11, 2016
7.0MM TI MATRIX POLYAXIAL SCREW 55MM THREAD LENGTH
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code NKB·March 19, 2013
CBCII BLOOD CONSERVATION RESERVOIR ONLY
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS PUERTO RICO·Product code CAC·March 1, 2011
MONORAIL MAVERICK 2
FDA Adverse Event
Malfunction
·Product code LOX·March 10, 2008
KNEE COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 26, 2022
CFF03, 5X100 KII FIOS ADVFIX 6/BX
FDA Adverse Event
Malfunction
·APPLIED MEDICAL·Product code GCJ·September 29, 2015
Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013
Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013