21 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
RIWOtrack Flexsensor
FDA UDI
Fiagon GmbH·04260759930096·Navigation probe, component of RIWOtrack Naviga...
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0120500·Screwdriver, Assembled Screws SNI1
InSePtion MIS Fixation System
FDA UDI
Kalitec Direct LLC·B07314K0120500·Inserter, All-In-One
PedFuse®
FDA UDI
SPINEFRONTIER, INC.·00190361012108·PedFuse Respond, SLD, 8.0mm x 50mm
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033444924·
SEEDNET, MODEL FP6T5, FP5T5, FP5T3
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CYPRESS SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
0009613348-2024-012950
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code DZE·September 30, 2024
S-ROM HEAD FEMORAL COCR 28+3
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code JDG·August 8, 2008
PINN MAR LIP LNR 28IDX52OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 8, 2008
MODULAR HEAD COMPONENT 28 MM HEAD DIAMETER STANDARD NECK TYPE 1 TAPER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·November 3, 2016
RINGLOC BI-POLAR 28X49MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWY·August 21, 2017
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·February 26, 2013
PRIMARY SUPER SECUR-FIT PLUS SIZE 7-11MM DISTAL S
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·March 2, 2011
MODEL 3000 30ML MED FLOW PUMP
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code LKK·March 13, 2008
ULTRAPRO MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·May 8, 2018
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·May 8, 2018
G7 DUAL MOBILITY LINER 44MM F
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·November 14, 2018
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