12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Percutaneous Nephroscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102695·MINARDI PHACO CHOPPER
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·October 21, 2020
TRULIANT TIB IMP CRC INSERT SZ 3.5,10MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·June 27, 2024
CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
Ion Endoluminal System
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 18, 2011
LINGEMAN UROLOGY/GYN DRAPES
FDA Adverse Event
Malfunction
·MICROTEK DOMINICA, S.A.·Product code KKX·August 27, 2014
HANA OPERATING ROOM TABLE
FDA Adverse Event
Injury
·MIZUHO ORTHOPEDIC SYSTEMS, INC.·Product code JEA·November 7, 2012
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024