12 results
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18ms
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Sources: EU EUDAMED, US FDA
UREA NITROGEN TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Brigade
FDA UDI
Nuvasive, Inc.·00887517961471·Brigade Lateral Trial, 12x34x24mm 15°
VuePoint
FDA UDI
Nuvasive, Inc.·00887517177858·VuePoint Screw, 3.5x34mm Lag Fav Angle
Punch
FDA UDI
ADLER ORTHO SPA·08053617185228·PUNCH FOR TIBIA MB GENUS PANTHEON SZ. 3-4
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515228979·Hook, 1mm rnd tip ang 90deg left
CARDIO MED
FDA 510(k)
FDA Class 2
·Cardiovascular
STICK NET
FDA 510(k)
FDA Class 2
·Dental
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 30, 2014
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·January 9, 2013
PFC SIGMA C/S NPOR FEM LT SZ 4
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JWH·November 16, 2010
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015
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