22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EMS PIEZON MASTER 600
FDA 510(k)
FDA Class 2
·Dental
Safco polycarbonate crowns
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310223283·Safco polycarbonate crowns #44 5/box
PYRENEES Cervical Plate System
FDA UDI
VB Spine LLC·10888857241985·Anti-Torque Guide, Constrained
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STYLE 68 SALINE FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FWM·March 21, 2024
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·October 27, 2020
OSTAPEK VBR CAGE
FDA Adverse Event
Injury
·COLIGNE AG·Product code MQP·September 19, 2019
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 27, 2013
PROXIMATE*PPH PROCEDURE SET
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·March 17, 2011
COAGUCHEK XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·March 27, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·April 8, 2021
CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·August 20, 2025
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·August 20, 2025
CD HORIZON® BALLAST¿ SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·February 6, 2024
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 24, 2022
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·November 24, 2022
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·October 17, 2023
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