15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SCORPIO NRG KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Graves Vu-Max X Long
FDA UDI
MEDGYN PRODUCTS, INC.·M803030978·Graves Vu-Max X Long 6 1/3" (161mm)
SCHILLER AG
FDA registration
SCHILLER AG·15 products·🇨🇭 Switzerland
ANATOMIC TOTAL KNEE PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DREAMSTATION CPAP PRO
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·February 13, 2026
DREAMSTATION AUTO CPAP
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 14, 2025
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 4, 2011
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.,·Product code CBK·July 30, 2014
UNK GEL BREAST IMPLANT
FDA Adverse Event
Injury
·UNKNOWN MANUFACTURER·Product code FTR·November 20, 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
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 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
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024