16 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450503324·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450573327·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450625101·
MODIFICATION TO OMEGA 21 SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
FDA 510(k)
FDA Class 2
·Ophthalmic
PRONTO SPOT CHECK PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 9, 2018
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·July 14, 2021
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·May 3, 2013
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 28, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·May 5, 2011
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·May 31, 2019
cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015
Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·January 24, 2018