11 results · 18ms · Sources: EU EUDAMED, US FDA

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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