13 results
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21ms
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Sources: EU EUDAMED, US FDA
OSTEOMEDICS RESORBABLE SMALL FIXATION SYSTEM, OSTEOSORB
FDA 510(k)
FDA Class 2
·Dental
OCTAGON Infinity BL NC Burn-out plastic coping for bridge/bar, Ø 3.5 mm
FDA UDI
Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM50220351·BL NC Burn-out plastic coping for bridge/bar, Ø...
Safco T&F Bur - 12 Bladed
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310220353·Safco T&F bur - 12 bladed, carbide, #7802 bulle...
Silverbolt/Mainframe
FDA UDI
Choice Spine, LP·10885862163691·
A1CNOW FOR PROFESSIONAL USE
FDA 510(k)
FDA Class 2
·Hematology
BRAUN PRECISION SENSOR PRO, MODEL BP 2590
FDA 510(k)
FDA Class 2
·Cardiovascular
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·March 26, 2013
ZOOM CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 10, 2011
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·March 31, 2008
ILAB ULTRASOUND IMAGING SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (CE)·Product code OBJ·July 24, 2014
Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018