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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W-5
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743700·ACHIMED ACHILLES SUPP SAND I
SEW-EASY®
FDA UDI
LSI Solutions, Inc.·00850200006650·SEW-EASY® CASSETTE SINGLES, 5mm
Reicodent
FDA UDI
devemed GmbH·04061644033218·Handle "Palti"
for osteotom- & bone pusher atta...
ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY
FDA 510(k)
FDA Class 2
·Dental
BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
True Position®
FDA UDI
ATLAS SPINE, INC.·M68112080228110·28mm x 11mm Non-Lordotic Spacer
Octane Straight PC
FDA UDI
Choice Spine, LP·10885862278111·
Octane Straight
FDA UDI
Choice Spine, LP·10885862235923·
ACHIEVA 1.5T MRI
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code LNH·March 21, 2013
SIMILE
FDA Adverse Event
Injury
·PENTRON CLINICAL·Product code EBF·March 17, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 28, 2008
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 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
The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.
FDA Enforcement
Class II
·Terminated·Welch Allyn Protocol, Inc·January 15, 2014