17 results
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27ms
·
Sources: EU EUDAMED, US FDA
BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Eye Shield
FDA UDI
KATENA PRODUCTS, INC.·00841668111161·FOX EYE SHIELD GARTERS WHITE PACK OF 50
Sklar®
FDA UDI
SKLAR CORPORATION·40649111216603·STER LLETZ BALL ELECT 3MM BX/5
Gen. Acces/ Instr. Tip Guard
FDA UDI
KATENA PRODUCTS, INC.·00841668112298·SURG-I-BAND BLACK
ENTERNAL INFUSER MULTIPUMP 203
FDA 510(k)
FDA Class 2
·General Hospital
POWERED TREADMILL (20/ST)
FDA 510(k)
FDA Class 1
·Physical Medicine
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024210295·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024210325·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024210288·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024210318·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024210301·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024210264·
NexGen® Legacy®
FDA UDI
Zimmer, Inc.·00889024210271·
FORCE FX-8C GENERATOR (SHANGHAI)
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·January 16, 2013
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 11, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 28, 2014
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