22 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Dornier MedTech
FDA UDI
Dornier MedTech GmbH·04049957005566·Genesis Urology Imaging System, Left, UV, FPD, ...
KARL STORZ
FDA UDI
Tecomet·00817766024375·TRAY, LAP CLICKLINE INSTRUMENT SET
DM: 23" X 10...
Table Top Rod Cutter 4.5 - 5.0 - 5.5 - 6.0
FDA UDI
TECOMET INC.·00841435109575·Table Top Rod Cutter
SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
Optimotion Blue CR HCCR Total Knee System
FDA UDI
OPTIMOTION IMPLANTS LLC·B6961014P0417010·CR Tibial Insert, UHMWPE + Vitamin E, Size 4, ...
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 8, 2013
FLEXTEND
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 6, 2011
INSIGNIA ULTRA
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DXY·May 8, 2008
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 14 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 14 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 11 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE EF 14 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 14 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018
TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 11 MM THICKNESS
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JWH·August 3, 2018
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Injury
·BECTON, DICKINSON & CO., (BD)·Product code FMI·April 19, 2022
3.5MM TI ROD 80MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KWP·January 28, 2020
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