14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VUSION TS, PS, AND CS PARTIAL VERTEBRAL BODY REPLACEMENTS
FDA 510(k)
FDA Class 2
·Orthopedic
Sklar®
FDA UDI
SKLAR CORPORATION·10649111117084·CUFF BLADDER ONLY THIGH
Baby Gorilla/Gorilla Plating System
FDA UDI
Paragon 28, Inc.·00889795021335·Baby Gorilla, Plate, DUB- Y 6-6-6, 18 Hole Lock...
PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DIAMOND ALOE VERA, STERILE
FDA 510(k)
FDA Unclassified
·Unknown
27 G X 3 1/2 IN. BD¿ WHITACRE HIGH FLOW, PENCIL POINT NEEDLE
FDA Adverse Event
Injury
·BD CARIBE LTD.·Product code BSP·July 27, 2016
27 G X 3 1/2 IN. BD¿ WHITACRE HIGH FLOW, PENCIL POINT NEEDLE
FDA Adverse Event
Injury
·BD CARIBE LTD.·Product code BSP·December 1, 2015
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 17, 2025
27 G X 3 1/2 IN. BD¿ WHITACRE HIGH FLOW, PENCIL POINT NEEDLE
FDA Adverse Event
Injury
·BD CARIBE LTD.·Product code BSP·November 10, 2015
PLUM A+
FDA Adverse Event
Malfunction
·HOSPIRA INC·Product code FRN·April 10, 2013
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·April 11, 2011
DEXTRUS 4137
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·June 10, 2008
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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015