13 results · 21ms · Sources: EU EUDAMED, US FDA

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SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES

FDA 510(k)
FDA Class 2 ·Dental

Baltic Denture System BD Load

FDA UDI
Merz Dental GmbH·D7091033065·Baltic Denture System BDLoad ↓ Mn6 PLSEum2DFm D...

SlimLine®

FDA UDI
ZIMMER SPINE, INC.·00889024403710·

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319701324·Meyhoefer Chalazion Curette 5" (12.5cm), size 4...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330150·Coronal Bender, Left

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0330050·Vise Grip, Large, 5.5mm

CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SEEDNET, MODEL EP6T5, EP5E5

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

8800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 1, 2013

ADVANTA BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·February 28, 2011

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 25, 2014

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024