16 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HANSATOME EXCELLUS MICROKERATOME
FDA 510(k)
FDA Class 1
·Ophthalmic
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310216403·FG Diamond 861-012 flame coarse ss 5/pack
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074034409·BONE SCREW 7021640 10 DEG ILC 6.5X40 SS
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450852903·
Disposable Silicone Foley Catheter
FDA UDI
Guangdong Baihe Medical Technology Co., Ltd.·06938634494817·
Disposable Silicone Foley Catheter Two-way 16Fr
FDA UDI
Guangdong Baihe Medical Technology Co., Ltd.·06938634494800·
Disposable Silicone Foley Catheter Two-way 16Fr
FDA UDI
Guangdong Baihe Medical Technology Co., Ltd.·06938634494794·
BIOSOFT RESIN
FDA 510(k)
FDA Class 2
·Dental
ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS
FDA 510(k)
FDA Class 2
·Orthopedic
PERFIX PLUG
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·March 15, 2013
TRIDENT 10DEG X3 INSERT 32MM ID
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code LPH·March 10, 2011
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·March 18, 2008
1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·January 21, 2015
BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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