16 results
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18ms
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Sources: EU EUDAMED, US FDA
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Channels
FDA UDI
HENRY SCHEIN, INC.·10304040160531·Channels Flex Assorted Pack 31mm .06 Taperx.0...
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827943·ACHIMED ACHILLES SUPP BLACK VI
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717106965·Paper Points, Taper .06, Size #30, 100pcs/box
SHAN SHUI SPECTACLES IND. CO., LTD.
FDA registration
SHAN SHUI SPECTACLES IND. CO., LTD.·2 products·🇹🇼 Taiwan
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450237915·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450412954·
HARDYDISK, CEPHALOTHIN 30MCG
FDA 510(k)
FDA Class 2
·Microbiology
MODIFICATION TO THE GRIP
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDEAVOR RESOLUTE RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·March 26, 2013
SCREWDRIVER AXSOS T20 5.0MM LOCKING SET
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 16, 2011
GENESIS II
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV·Product code HSH·March 28, 2008
MITRACLIP CLIP DELIVERY SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR·Product code NKM·January 22, 2020
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
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