20 results · 23ms · Sources: EU EUDAMED, 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