20 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO: NUVASIVE SPHERX II SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Non-Locking Screw, 2.7mm x 28mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665026368·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694008754·3.0mm x 28mm Lag Screw
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A08302880·8mm H x 30mm W x 28mm L x 8 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A083028120·8mm H x 30mm W x 28mm L x 12 degrees ALIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587A083028150·8mm H x 30mm W x 28mm L x 15 degrees ALIF
OsteoMed
FDA UDI
OSTEOMED LLC·00845694035286·3.0 x 28mm Lag Screw, Sterile
OsteoMed
FDA UDI
OSTEOMED LLC·00845694067607·3.0 x 28mm Lag Screw Sterile Qty 5
PALOMAR SLP 1000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 9, 2024
SINAI HSP BALTIMORE MD 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·July 6, 2011
LAKELAND REG LAKELAND FL 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DWF·May 3, 2010
WA ADVENT TAKOMA PARK MD 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011
IOWA METH DES MOINES IA1
FDA Adverse Event
Malfunction
·SORIN GROUP USA, INC.·Product code DTZ·March 7, 2011
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code KPE·April 29, 2013
ATTAIN ABILITY
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·May 10, 2011
MTOME ST HOLSTER/CABLES
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code KNW·July 23, 2008
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 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