9,983 results
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72ms
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Sources: EU EUDAMED, US FDA
COUPLET CARE, INC.
FDA registration
COUPLET CARE, INC.·1 product·🇺🇸 United States
Couplet Care Bassinet
FDA UDI
Couplet Care, Inc.·00199284746916·The Couplet Care Bassinet is for use in hospita...
Hemoccult II BRAND SENSA elite; MATERIALS AND REAGENTS; Hemoccult II SENSA elite Slides (Test Cares) containing guaiac paper; Hemoccult SENSA Developer-a developing solution containing a stabilized mixture of less than 4.2% hydrogen peroxide, 80% denatured ethyl alcohol and enhancer in an aqueous solution; Applicator Sticks; Patient Screening Kit Dispensing Envelopes with Patient Instructions; Flushable Collection Tissues; Mailing Pouches (for returning completed Test Cares); Hemoccult II SENSA elite Product Instructions; Beckman Coulter, Inc.; 250 S. Kraemer Blvd.; Brea, CA 92821 The Hemoccult II SENSA elite test is a rapid, convenient and qualitative method for detecting fecal occult blood which may be indicative of gastrointestinal disease. It is not a test for colorectal cancer or any other specific diseases. The Hemoccult II SENSA elite test is recommended for professional use as a diagnostic aid during routine physical examinations, for hospital patients to monitor for gastrointestinal bleeding in patients with iron deficiency anemia or recuperating from surgery, peptic ulcer, ulcerative colitis and other conditions, and in screening programs for colorectal cancer when the Patient Instructions are closely followed. Serial fecal specimen analysis is recommended when screening symptomatic patients. The Hemoccult II SENSA elite test and other unmodified guaiac tests are not recommended for use with gastric specimens.
FDA Enforcement
Class II
·Terminated·Assuramed·September 25, 2013
Biphasic LIFEPAK 15 Monitor/Defibrillator. Manufactured by Physio-Control Inc., a division of Medtronic, Inc. Redmond, Washington USA. The LIFEPAK 15 monitor/defibrillator is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient protocols.
FDA Recall
Terminated
·Physio Control, Inc.·Product code MKJ·March 4, 2010
pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO).
FDA Enforcement
Class II
·Terminated·Sysmex America Inc·November 6, 2013
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·July 31, 2020
SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handpiece connections. The Micadent is used to perform intra¿ oral air abrasion procedures including etching and preparing surfaces for composite restoration. The SEAC Advanced Dental System is substantially similar in design and functions as the SEAC Mobile Dental System manufactured by ASI Medical, Inc. The Micadent is manufactured by Medidents and will be supplied to ASIas a completed product. The Micadent is substantially the same as it is provided and is attached to an accessory air line inside the SEAC unit for operation. It is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.
FDA Enforcement
Class II
·Terminated·ASI Medical, Inc.·December 25, 2013
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·March 24, 2020
INTRODUCER KIT FOR IMPELLA®
FDA Adverse Event
Injury
·OSCOR INC.·Product code DYB·November 30, 2023
BAB FLEXIBLE FABRIC BANDAGES
FDA Adverse Event
Injury
·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·April 18, 2023
J&J BAND AID BRAND CUSHION CARE SPORTS STRIP
FDA Adverse Event
Injury
·JOHNSON & JOHNSON CONSUMER INC·Product code KGX·May 13, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 30, 2023
LUMEX
FDA Adverse Event
Injury
·GF HEALTH PRODUCTS, INC.·Product code FNL·October 17, 2016
ENDOWRIST
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL, INC·Product code NAY·March 31, 2025
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·August 19, 2019
AVANTA FLUID MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·BAYER MEDICAL CARE INC·Product code DXT·September 4, 2024
STELLANT DUAL CT INJECTOR
FDA Adverse Event
Injury
·BAYER MEDICAL CARE INC·Product code DXT·July 5, 2024
ROTA-FLOW CONTROL UNIT
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code DWA·June 9, 2006
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code GDW·December 4, 2024
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·December 29, 2021