13 results
·
21ms
·
Sources: EU EUDAMED, US FDA
MCCONNELL REAMER GUIDE
FDA 510(k)
FDA Class 1
·Orthopedic
3M™ Forsus™
FDA UDI
3M UNITEK CORPORATION·00652221110350·3M™ Forsus™ Fatigue Resistant Device, 885-100, ...
UniTip Catheter
FDA UDI
Unisensor AG·07640172973721·
ARx SAI
FDA UDI
Life Spine, Inc.·00190837175238·
S.L.T. CONTACT LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TISSUE-EQUIVALENT BREAST SIMULATOR
FDA 510(k)
FDA Class 1
·Radiology
PECTUS SYSTEM DEFAZIO 13 TI PECTUS BAR
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·February 24, 2020
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 19, 2014
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·October 28, 2010
ALLEGRETTO WAVE EYE-Q
FDA Adverse Event
Injury
·WAVELIGHT GMBH·Product code GEX·December 19, 2012
PECTUS SYSTEM DEFAZIO 13.5 TI PECTUS BAR
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·February 24, 2020
XP-XP Tibial Tray - Interlok 73 mm Item # 195756
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020