19 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BCI 3180 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040115258·OBTURATOR - VER - SIZE 50 Verifier 6 Pack - VSM
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717103506·Midway Select Disposable Diamonds 856-014SC, Pk...
Flex
FDA UDI
Diversified Products, Inc.·00037741502098·
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037308882·PROTECTOR Ø50 mm
SCREENERS COCAINE TEST; DRUGSCREEN DIP COCAINE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
REFACTO LABORATORY STANDARD
FDA 510(k)
FDA Class 2
·Hematology
HammerTube System
FDA UDI
Paragon 28, Inc.·00889795057679·HammerTube Implant, 3.50mm, 10° Cannulated
HammerTube™ System
FDA UDI
Paragon 28, Inc.·00889795033994·HammerTube Implant, 3.50mm, 10° Cannulated STERILE
HammerTube™ System
FDA UDI
Paragon 28, Inc.·00889795128478·HammerTube System Peek Implant, Ø3.50mm x 16mm,...
HammerTube™ System
FDA UDI
Paragon 28, Inc.·00889795128485·HammerTube™ System Implant Kit, Ø3.50 x 16mm, 1...
HammerTube™ System
FDA UDI
Paragon 28, Inc.·00889795057723·HammerTube™ System Implant Kit, Ø3.50 x 16mm, 1...
OPTETRAK LOGIC
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 24, 2023
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 25, 2013
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·Product code LYJ·March 11, 2011
ZENITH AAA ILIAC LEG GRAFT
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·March 27, 2008
Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·December 11, 2013
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
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 6, 2015