18 results
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20ms
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Sources: EU EUDAMED, US FDA
ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Acrylic C&B dispensing gun
FDA UDI
SAFCO DENTAL SUPPLY CO.·D72310205850·Safco 10:1 plunger for C&B gun
Channels
FDA UDI
HENRY SCHEIN, INC.·10304040161057·Channels Flex 31mm 50.06
BUSCH®, BNA®
FDA UDI
BUSCH & CO. GmbH & Co. KG·D8120205851·Carbide, cylinder flat, excavating and fissure bur
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·00843717106661·Midway Select Flowable Composite A3 4 x 1.5g + ...
RANDOX TRANSFERRIN
FDA 510(k)
FDA Class 2
·Immunology
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
FDA 510(k)
FDA Class 2
·Orthopedic
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 1, 2025
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 31, 2007
AXERA 2 ACCESS SYSTEM
FDA Adverse Event
Injury
·ARSTASIS INC.·Product code DYB·March 21, 2013
CONCHA NEPTUNE HEATER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTT·February 10, 2011
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·August 11, 2025
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·March 20, 2025
INTROCAN SAFETY®
FDA Adverse Event
Malfunction
·B BRAUN MELSUNGEN AG·Product code FOZ·October 2, 2025
INTROCAN SAFETY®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code FOZ·April 10, 2025
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