14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TETRA NATAL-MAT WATER FLOTATION MAT.
FDA 510(k)
FDA Class 1
·General Hospital
NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER
FDA 510(k)
FDA Class 2
·Radiology
ACUMATCH L-SERIES FEMORAL STEM, CEMENTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code LWJ·May 5, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 24, 2012
INSYNC SENTRY
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 17, 2010
CORTSCR Ø3.5 SELF-TAP L40 TI
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·July 12, 2013
LOCKSCR Ø3.5 SELF-TAP L30 TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·July 12, 2013
LOCKSCR Ø3.5 SELF-TAP L40 TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·July 13, 2013
3.5MM TI LOCKING SCREW SELF-TAPPING 40MM
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·July 12, 2013
LOCKSCR Ø3.5 SELF-TAP L50 TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code KTT·July 12, 2013
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; CD1211-36/100006983, 100012542, 100016679, 100031495, 100035634, 100035635, 100042587, 100047090; CD1211-36Q/100004079, 100004081, 100019783, 100035607, 100042591, 100047191; CD1215-36/100006990, 100010230, 100010241, 100010242, 100010244, 100012563, 100012564, 100034631, 100046574, 100046786; CD1215-36Q/100006768, 100006769, 100006770, 100023300, 100030306, 100033794, 100042402, 100046720, 100046904; CD1217-36/100011824; CD1219-36/100002160, 100002864, 100011826; CD1219-36Q/100004071, 100023301; CD2211-36/100006982, 100012536, 100016678, 100031440, 100035629, 100035636, 100042520, 100047192; CD2211-36Q/100004085, 100004087, 100019782, 100035587, 100042575, 100047193; CD2215-36/100006992, 100010224, 100010226, 100010227, 100010228, 100012515, 100012516, 100036606, 100046676, 100046792, 60019063; CD2215-36Q/100006762, 100006763, 100006764, 100023302, 100029180, 100033793, 100042404, 100046789, 100046905; CD2217-36/100011828, 100046991, 60016124-401; CD2219-36/100002139, 100002140, 100002862, 100011830; CD2219-36Q/100023303
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018