5,504 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Medtronic HVAD Pump Implant Kits
FDA Recall
Open, Classified
·Heartware, Inc.·Product code DSQ·August 6, 2021
Scrip Creme All Purpose Lotion Intended for use in acoustic coupling of ultrasound transducer to tissue
FDA Recall
Open, Classified
·Scrip Inc·Product code ITX·August 18, 2021
LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
FDA Recall
Open, Classified
·CooperSurgical, Inc.·Product code HGI·September 29, 2021
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075
FDA Recall
Open, Classified
·CooperSurgical, Inc.·Product code HGI·September 29, 2021
LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
FDA Recall
Open, Classified
·CooperSurgical, Inc.·Product code HGI·September 29, 2021
HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve, Handle only, with Cojoined Suction and Irrigation Tubing, Catalog number 0026880
FDA Recall
Open, Classified
·Davol, Inc.·Product code GCJ·June 7, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;
FDA Recall
Open, Classified
·Exactech, Inc.·Product code KWZ·August 11, 2022
RipCord Syndesmosis Button, REF: STA001K
FDA Recall
Open, Classified
·TriMed Inc.·Product code HTN·December 22, 2022
PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples
FDA Recall
Open, Classified
·Entopsis Inc.·Product code JJH·February 21, 2023
PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples
FDA Recall
Open, Classified
·Entopsis Inc.·Product code JJH·February 21, 2023
PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples
FDA Recall
Open, Classified
·Entopsis Inc.·Product code JJH·February 21, 2023
MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
FDA Recall
Open, Classified
·Biomerieux Inc·Product code OUG·February 6, 2023
Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 405011000
FDA Recall
Open, Classified
·Ambu Inc.·Product code FEM·July 21, 2023
Impella CP Smart Assist Set, Canada; Product Code: 0048-0044;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 5, 2024
Impella 5.5 Set AU; Product Code: 1000361;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 5, 2024
Pump 371 14F LT CMR Set; Product Code: 0048-0045;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 5, 2024
Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;
FDA Recall
Open, Classified
·Abiomed, Inc.·Product code OZD·August 5, 2024
Diasol Acid Concentrate REF G100325-10Dex 100
FDA Recall
Open, Classified
·Diasol, Inc·Product code KPO·July 27, 2022
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
FDA Recall
Open, Classified
·ImaCor Inc.·Product code ITX·September 16, 2024
1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight connection between breathing circuits and patient interface (tracheal tube, tracheostomy tube, or mask).
FDA Recall
Open, Classified
·Westmed, Inc.·Product code BZA·September 27, 2024