18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AMMONIA ASSAY FOR THE ADVIA 1650
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Ophthalmic Hooks
FDA UDI
KATENA PRODUCTS, INC.·00841668114315·PUSH-PULL HOOK ANGLED (BX/3)
3DFIS, MODEL IES-FL-101
FDA 510(k)
FDA Class 2
·Radiology
AVON PATELLAR COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code HWC·September 23, 2015
M2A-MAGNUM PF CUP 62ODX56ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 12, 2013
MLRY-HD POR FMRL 11X160MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·November 12, 2013
M2A-MAGNUM 52-60MM TAPER INS STD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 12, 2013
IVT DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MALTA·Product code LHI·March 27, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 14, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 2, 2008
APPLIANCE, FIXATION, NAIL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KTT·August 18, 2015
DRILL BIT Ø1.1 L70/39 F/CORE HOLE
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTW·November 20, 2019
APPLIANCE,FIXATION,NAIL
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code KTT·October 10, 2016
M2A-MAGNUM MODULAR HEAD SIZE 56MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 27, 2013
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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·November 9, 2016