12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
TITANIUM/STAINLESS STEEL INSTRUMENTS
FDA 510(k)
FDA Class 2
·Dental
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978957791·INNER TRAY 902-911 ANTERIOR GEN INST
EYEVAN7285
FDA UDI
EYEVAN INC.·04582669060961·
SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
XSCAN32 TELERADIOLOGY SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
LCS COMPLETE FEM POR L LG
FDA Adverse Event
Injury
·DEPUY IRELAND·Product code NJL·January 9, 2013
EVERCROSS PTA BALLOON CATHETER -6MM X 200MM, L =
FDA Adverse Event
Other
·EV3 ENDOVASCULAR INC.·Product code DQY·November 12, 2010
PLM A+ SPANISH 110V
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 24, 2014
ONYX
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·November 10, 2024
EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWB·October 28, 2018
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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