21 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SYNAPSE 3D TENSOR ANALYSIS
FDA 510(k)
FDA Class 2
·Radiology
BIOMET KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304000056·
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868248061·
Biomet® Knee System
FDA UDI
Biomet Orthopedics, LLC·00887868558900·
BIOMET SMOOTH KNEE STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·September 22, 2019
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221037596·Unitek(TM) Bicuspid Band General Purpose Narrow...
BIOMET ILOK STEM TIBIAL TRAY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·September 22, 2019
VANGUARD KNEE SYSTEM PS TIBIAL BEARING DCM ARCOM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HRY·September 22, 2019
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973101888·Poly Insert MPCS, Size 5R, 14mm
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD DIRECTIGEN EZ RSV
FDA 510(k)
FDA Class 1
·Microbiology
VNGD PS TIB BRG 10X71/75MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·August 26, 2016
VNGD SSK PSC TIB BRG 18X71/75
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 23, 2016
CADD-SOLIS VIP AMBULATORY INFUSION PUMP
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FRN·October 23, 2024
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 1, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
VANGUARD PS OPEN BOX FEMORAL 65MM RIGHT ¿ INTERLOK FOR CEMENTED USE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·December 1, 2016
BIOMET SPLINED KNEE STEM W/STEM 20 MM X 80 MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·May 11, 2017
Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN29NRCCA; 6) Neurological Tray, Catalog Number SANV1NIYH2; 7) Neurological Tray, Catalog Number SANV1NIYH3; 8) Neurological Tray, Catalog Number SANV1NIYH4; 9) Neurological Tray, Catalog Number SANV1NIYH5; 10) Neurological Tray, Catalog Number SANV1NIYH6; 11) Neurological Tray, Catalog Number SANV1NIYH7; 12) Neurological Tray, Catalog Number SANV1NIYHD; 13) Neurological Tray, Catalog Number SANV1NIYHE; 14) Neurological Tray, Catalog Number SANV1NIYHF; 15) Neurological Tray, Catalog Number SANV2INEH4; 16) Neurological Tray, Catalog Number SANV2INEHG; 17) Neurological Tray, Catalog Number SANV2INEHH; 18) Neurological Tray, Catalog Number SNE29NRCCC; 19) Neurological Tray, Catalog Number SNECGMEUCA; 20) Neurological Tray, Catalog Number SNECGNIUC3; 21) Neurological Tray, Catalog Number SNECGNIUCA; 22) Neurological Tray, Catalog Number SNEMHNTWD1; 23) Neurological Tray, Catalog Number SNEMHNTWDA
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·July 17, 2024