15 results
·
26ms
·
Sources: EU EUDAMED, US FDA
HEXCEL FEMORAL COMPONENT HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
TruForm
FDA UDI
Rmo, Inc.·00885797099563·MAN 1ST MOLAR UNIV 109 BANDS
BaseVac
FDA UDI
R. E. Morrison Equipment Inc·D13028000510·3SUR4.25-2 | 14 User Triple Surgical Vacuum | N...
ACUMED
FDA UDI
Acumed LLC·10806378039577·Radiolucent VDR Tgt Guide Narrow, L
Elite Expandable Interbody Fusion System
FDA UDI
SPINEOLOGY INC.·M7402800051·Slap Hammer
SONIALVISION G4
FDA UDI
SHIMADZU CORPORATION·04540217040872·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197418584·Vaginal Frame, oval
20° an...
VIRTUAL PORTS ENDOCLEAR SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACTICOAT FOAM DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 8, 2014
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code FMF·October 17, 2012
LEGEND DISSECTING TOOL
FDA Adverse Event
Malfunction
·MEDTRONIC POWERED SURGICAL SOLUTIONS·Product code HBE·August 11, 2010
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 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