10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TIGRT IVS
FDA 510(k)
FDA Class 2
·Radiology
Prime
FDA UDI
C A I INDUSTRIES CORP·00807689000280·0.25x50mm acupuncture needles (10 needles with ...
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
FDA 510(k)
FDA Class 2
·Hematology
RDH BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital
INTRAMEDULLARY ARTHRODESIS IMPLANT SMART TOE II 19MM / 10° ANGLE FOR PIP ARTHRO
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-SELZACH·Product code HTY·May 3, 2013
CAD II
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·September 16, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 2, 2011
VANGUARD SSK 360 FEMUR RIGHT WITH SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 22, 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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015