20 results
·
34ms
·
Sources: EU EUDAMED, US FDA
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CD SPINAL FIXATION SYSTEM
FDA Adverse Event
Injury
·SOFAMOR DANEK EUROPE·Product code JDN·June 4, 1999
ILT 0.014 CATHETER, MODEL C114NL2
FDA 510(k)
FDA Class 2
·Cardiovascular
FHC MICROTARGETING DRIVE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DANEK PLATE AND SCREW
FDA Adverse Event
Injury
·SOFAMOR DANEK MANUFACTURING·Product code KWQ·February 19, 1999
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2024
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 9, 2011
AUTOTOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNS·July 23, 2008
BLUNT TIP SCREW, ÿ 4X36MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·August 2, 2022
BLUNT TIP SCREW, ÿ 4X48MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·August 3, 2022
BLUNT TIP SCREW, ÿ 4X46MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·August 2, 2022
BLUNT TIP SCREW, 4X44MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·August 4, 2022
PROXIMAL HUMERUS, RIGHT, ÿ 9X160MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·August 2, 2022
PROXIMAL HUMERUS, LEFT, 11X160MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·August 4, 2022
BLUNT TIP SCREW, 4X44MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·August 4, 2022
BLUNT TIP SCREW, 4X42MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·August 4, 2022
BLUNT TIP SCREW, 4X52MM
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code HSB·August 4, 2022
Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·February 3, 2021
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