16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADVIA 1650 CHOLINESTERASE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Toxicology
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361012931·PedFuse Remind LES, Quad-H, 6.0mm x 50mm
P7-3P Ultrasonic Probe(FDA)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06936415911317·
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A DE C.V·Product code FPA·May 31, 2026
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A DE C.V·Product code FPA·May 31, 2026
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 13, 2026
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 13, 2026
PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
FDA 510(k)
FDA Class 2
·Hematology
ADC PEDIATRIC
FDA 510(k)
FDA Class 2
·Radiology
NV MICROCATHETER
FDA Adverse Event
Injury
·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 9, 2020
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·March 20, 2013
LOCKING PLATE, SAGITTAL SPLIT, 12MM BAR, 6 HOLE, O
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·February 4, 2011
PFC SIGMA STAB INS SZ4 12.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·March 13, 2008
OSS TIBIAL POLY BEARING 22MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·May 22, 2025
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022