19 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113836·PS-C Insert, Size 6 x 20mm
36M - MSHA Miners
FDA UDI
Certified Safety Manufacturing, Inc.·00766588026206·36M - MSHA Miners
Reicodent
FDA UDI
devemed GmbH·04061644048779·Crown Scissors "Beebee" | 12 cm
curved, saw edge
SE-200
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SURESMILE SYSTEM
FDA 510(k)
FDA Class 1
·Dental
TAPERLOC MICROPLASTY FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 21, 2018
M2A-MAGNUM TAPER ADAPTER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 21, 2018
CONTOUR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·March 13, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·March 17, 2011
COULTER AC.T DIFF 2 ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·March 31, 2008
M2A-MAGNUM PF CUP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·March 21, 2018
TAPERLOC MICRO LATERAL FEMORAL 11MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 7, 2018
M2A-MAGNUM 52-60MM TAPER INSERT-3
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·May 7, 2018
TAPER ADAPTOR REMOVAL ASSEMBLY
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·March 26, 2018
AIA-2000
FDA Adverse Event
Malfunction
·TOSOH CORPORATION·Product code KHO·August 24, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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
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