17 results
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29ms
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Sources: EU EUDAMED, US FDA
MITYVAC MERLIN, MODEL 10027
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717104428·Stainless Steel H Files (Hand), Size # 35, Leng...
N/A
FDA UDI
SALTER LABS·00607411300677·Nasal Cannula (adult) TLCannula™ with 7' (2.1 m...
NA
FDA UDI
STRYKER CORPORATION·04546540078360·4.7mm x 16.4mm Fluted Drum
NA
FDA UDI
STRYKER CORPORATION·04546540079411·4.7mm x 16.4mm Fluted Drum
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MODIFICATION TO RAPID DRUG SCREEN 9-PANEL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BD CHECK VALVE,MALE/FEMALE LUER LOCK
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·November 24, 2021
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 31, 2007
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 26, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 7, 2011
BIOLOX DELTA, CERAMIC FEMORAL HEAD, M¸ 28/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·October 17, 2018
BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·October 17, 2018
ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code MIH·December 18, 2024
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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