14 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
STELKAST UNICONDYLAR KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NONE - SEE PHYSICIAN COMMENTS IN H10.
FDA Adverse Event
Injury
·Product code JWH·October 16, 2013
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032824·Baltic Denture System BDLoad Mw6 PLSEbim6DFm A3...
BD MICRO FINE PLUS ¿ 31 G × 5 MM PEN INJECTOR NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·October 3, 2017
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PCA PLS II
FDA Adverse Event
Injury
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 28, 2013
SYNCHRON LX® I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·March 29, 2011
PUMP MMT-522NAL PRDGM INS V2.2 CL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·April 21, 2008
130 DEG AIMING ARM F/TROCHANTERIC FIXATION NAILS
FDA Adverse Event
Malfunction
·SYNTHES HAGENDORF·Product code FZX·March 6, 2015
HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor Product Number: 72203707
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018