17 results
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28ms
·
Sources: EU EUDAMED, US FDA
FITC MURINE MONOCLONAL ANTI-INFLUENZA TYPE B
FDA 510(k)
FDA Class 1
·Microbiology
MOR® Implant 3.0 X 18mm, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549108273·The MOR is a self-tapping, small diameter, scre...
ORTHO SELECT BONE PLATES AND SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001
FDA 510(k)
FDA Class 1
·Dental
UNKPALMAZCORONARY
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code MAF·May 10, 2021
UNKNOWN GUIDING CATHETER CARDIOLOGY
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code OEQ·May 10, 2021
UNK
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·June 13, 2014
BABY CONTROL MOBILE INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code FMT·June 30, 2014
BD ECLIPSE
FDA Adverse Event
Malfunction
·BD·Product code FMI·November 9, 2010
RUSCH GREENSPEC STUBBY HANDLE
FDA Adverse Event
Malfunction
·TELEFLEX·Product code CCW·January 3, 2013
SET SCREW, TI GAMMA3® Ø8X17.5MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·July 22, 2014
UNKNOWN GUIDING CATHETER CARDIOLOGY
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code OEQ·May 11, 2021
UNKNOWN PALMAZ STENT
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code FGE·May 17, 2021
UNKNOWN PALMAZ STENT
FDA Adverse Event
Injury
·CORDIS CORPORATION·Product code FGE·May 11, 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
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024