21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MAMMOTOME MR BIOPSY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809869606·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...
SORING GMBH SONOCA 180/190
FDA 510(k)
FDA Unclassified
·Unknown
SPARTAN A-10
FDA 510(k)
FDA Class 2
·Dental
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 71/75 X 14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 71/75X14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016
CORAIL2 NON COL HO SIZE 10
FDA Adverse Event
Injury
·DEPUY FRANCE·Product code MEH·April 9, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·April 6, 2011
FINELINE II
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING 63/67X14MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 7, 2016
VANGUARD DA 360 TIBIAL BEARING ARCM 71/75X16
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 28, 2017
VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·February 6, 2017
VG DA360 TIB BRG ARCM 79/83X14 3 X 14MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDG·October 31, 2017
VANGUARD DA 360 KNEE SYSTEM ARCOM TIBIAL BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·November 2, 2017
VANGUARD DUAL ARTICULATING (DA) BEARING 71/75 X 16 MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·October 13, 2016
VANGUARD DA 360 TIBIAL TRAY
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·April 27, 2017
VANGUARD SSKPSC TIBIAL BEARING S 12X63/67
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·July 21, 2017
VANGUARD DA360 TIBIAL BEARING ARCOM 63/67X18
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JWH·June 9, 2017
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 2019
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