11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HIP PLATE REMOVAL INSTRUMENT
FDA 510(k)
FDA Class 1
·Orthopedic
Daytona Small Stature
FDA UDI
Seaspine Orthopedics Corporation·10889981185145·Precontoured Ti Rod, 4.5 x 300mm
DuoGard
FDA UDI
STRYKER CORPORATION·07613327282283·
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Margolin HSG Cannula, Goldstein Sonohysterography Catheter
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
APPLICATION INSTRUMENT FOR STERNAL ZIPFIX
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code JDQ·September 28, 2015
GOLD PROBE¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code KNS·October 10, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·December 3, 2013
PUMP MMT-522LNAL PRDGM INS CL EN ML
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·July 26, 2010
XP-XP Tibial Tray - Interlok 83 mm Item # 195759
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022