13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CENTIFUGE, HEMATOCRIT & MICROSEDIMENTATION COMBINE
FDA 510(k)
FDA Class 2
·Hematology
2.4MM LOCKING RECON SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036060053·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111205316·GUYON SOUND W/O THREAD 16FR
ZERO Profile Interlocking Cortex Screw, 3.5mm x 16mm, T15, Flex-Thread™
FDA UDI
FLOWER ORTHOPEDICS CORPORATION·00840118116831·Intramedullary fixation screw
2.4MM LOCKING RECON SYSTEM HT CROSS-DRIVE LOCKING RECON SCREW,5/PK
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·December 6, 2019
ATTUNE CRS RP INSRT SZ 7 14MM
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code NJL·March 13, 2024
BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks
FDA 510(k)
FDA Class 2
·Microbiology
STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137
FDA 510(k)
FDA Class 2
·General Hospital
POLYAXIAL REDUCTION PEDICLE SCREWDRIVER 2.0 CANNULATED
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·November 20, 2018
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2014
RECEPTAL CANISTER 1000 ML CE
FDA Adverse Event
Malfunction
·AMSINO MEDICAL CO., LTD.·Product code GCX·November 15, 2012
SOLETRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 18, 2015
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022