20 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AROMACRYL
FDA 510(k)
FDA Class 2
·Dental
Safco FG Diamonds
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310211213·FG Diamond 811L-037 barrel coarse 5/pack
RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
FDA 510(k)
FDA Unclassified
·Unknown
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
FDA 510(k)
FDA Class 2
·Anesthesiology
WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·March 2, 2022
WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·January 21, 2022
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 26, 2013
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 19, 2014
ATTAIN OTW
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 16, 2011
GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 2)
FDA Adverse Event
UNK·Product code MDS·September 29, 2021
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTL·July 27, 2010
STRATA®
FDA Adverse Event
Injury
·COVIDIEN LLC·Product code JXG·April 19, 2022
STRATA®
FDA Adverse Event
Death
·COVIDIEN LLC·Product code JXG·April 19, 2022
STRATA®
FDA Adverse Event
Malfunction
·COVIDIEN LLC·Product code JXG·April 19, 2022
BACT/ALERT I NST 100 BTLS - 259785
FDA Adverse Event
Malfunction
·BIOMÉRIEUX INC.·Product code MDB·March 4, 2024
RESPIRATORY HUMIDIFIER
FDA Adverse Event
FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·January 4, 2011
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·July 29, 2022
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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