73 results · 13ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

FDA Recall
Terminated ·Medical Action Industries Inc·Product code OVN·June 12, 2014

Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

FDA Recall
Terminated ·Medical Action Industries Inc·Product code OVN·June 12, 2014

McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228

FDA Recall
Terminated ·Medical Action Industries Inc·Product code OVN·June 12, 2014

Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

FDA Recall
Terminated ·Medical Action Industries Inc·Product code OVN·June 12, 2014

Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

FDA Recall
Terminated ·Medical Action Industries Inc·Product code OVN·June 12, 2014

Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.

FDA Recall
Terminated ·Medical Action Industries Inc·Product code OVN·June 12, 2014

Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.

FDA Recall
Terminated ·Medical Action Industries Inc·Product code OVN·June 12, 2014

AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

FDA Enforcement
Class II ·Terminated·Avanos Medical, Inc.·June 14, 2023

AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

FDA Enforcement
Class II ·Terminated·Avanos Medical, Inc.·June 14, 2023

P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only

FDA Enforcement
Class II ·Terminated·Paragon 28, Inc.·December 18, 2019

AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509

FDA Recall
Terminated ·Avanos Medical, Inc.·Product code FRN·April 24, 2023

AVNS ambIT System - PIB/PCA W 5in Cath, Product Code: 220507

FDA Recall
Terminated ·Avanos Medical, Inc.·Product code FRN·April 24, 2023

MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.

FDA Enforcement
Class II ·Terminated·Mevion Medical Systems, Inc.·August 22, 2018

P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only

FDA Recall
Terminated ·Paragon 28, Inc.·Product code PLF·September 28, 2018

Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086

FDA Recall
Terminated ·Siemens Healthcare Diagnostics Inc·Product code NBC·November 11, 2015

Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NTproBNP) in heparinized plasma. Catalog Number: CPBNPM SMN: 10445086

FDA Enforcement
Class II ·Terminated·Siemens Healthcare Diagnostics Inc·January 13, 2016

PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.

FDA Recall
Terminated ·Polymedco, Inc., Polymedco Cancer Diagnostic Products, Llc·Product code NBC·April 30, 2018

PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.

FDA Enforcement
Class II ·Terminated·Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc·September 26, 2018

PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma.

FDA Recall
Terminated ·Polymedco, Inc., Polymedco Cancer Diagnostic Products, Llc·Product code JHX·April 30, 2018

NexGen Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; Collagen disorders, and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, varus, or flexion deformities.

FDA Recall
Terminated ·Zimmer, Inc.·Product code JWH·October 31, 2013