12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
GEORGE TIEMANN & CO.·B582081242·ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810057370557·STRETCHER PAD 26" W X 3.5" H X 74" L DELUXE
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0112420·Awl Tap, 4.75 mm, Fixed Sleeve
ISOLETTE INFANT INCUBATOR, MODEL C2HS
FDA 510(k)
FDA Class 2
·General Hospital
HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
FDA 510(k)
FDA Class 2
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 26, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·April 26, 2011
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GDW·July 23, 2008
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018