15 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR
FDA 510(k)
FDA Class 2
·Radiology
Titan Modular Shoulder System 2.5
FDA UDI
Smith & Nephew, Inc.·00885556859872·TSS GLENIOD INSTRUMENT TRAY - BASE ASSEMBLY
Zavation
FDA UDI
Zavation LLC·00842166128217·Ti3Z PLIF 9mmx23mmx7mm -5deg
Zavation
FDA UDI
Zavation LLC·00842166129917·Ti3Z PLIF 09mmx23mm
Titan™
FDA UDI
Ascension Orthopedics, Inc.·10381780243311·Titan™ Total Shoulder System
The Titan Modular ...
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 21, 2022
KONRAD, MODEL V.2.0
FDA 510(k)
FDA Class 2
·Radiology
LUXACORE/LUXACORE DUAL
FDA 510(k)
FDA Class 2
·Dental
Zavation
FDA UDI
Zavation LLC·00842166125810·Posterior TiPK-LEIF-C 9x23 Convex-7
CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code GEI·April 15, 2015
S-ROM*STM STD,36NK,16X11X150
FDA Adverse Event
Injury
·DEPUY (IRELAND) 9616671·Product code JDI·May 3, 2013
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 3, 2011
ONETOUCH BASIC ENHANCED METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·August 1, 2008
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
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