18 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
FDA 510(k)
FDA Class 2
·Radiology
Latitude™ EV
FDA UDI
TORNIER, INC.·00846832002559·Ulnar Stem - Coated
Septal splints
FDA UDI
Spiggle & Theis Medizintechnik GmbH·04250381809679·silicone
steril...
SOLID CANCELLOUS LAG SCREW
FDA UDI
Biomet Orthopedics, LLC·00887868005770·
Mariner Outrigger
FDA UDI
Seaspine Orthopedics Corporation·10889981174866·Z-Rod, Dia. 5.5mm, Titanium, 110mm
LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.)
FDA UDI
Medtimo, Inc·10850007764330·LAP-BAND® Access Port Needle 3.5 inch Pouch
Bone Screws
FDA UDI
ORTHOPEDIATRICS CORP.·00841132134023·4.0 BONE SCREW SYSTEM - CASE COMPLETE (INC IMPS...
MEDCOMP BIO-CATH CATHETER LINE
FDA 510(k)
FDA Class 2
·General Hospital
POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE
FDA 510(k)
FDA Class 1
·General Hospital
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 14, 2011
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·April 2, 2013
COULTER LH 750 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code LOQ·March 26, 2011
CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·April 14, 2008
2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWC·February 28, 2023
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 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
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016
Spirit Select Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016