20 results
·
26ms
·
Sources: EU EUDAMED, US FDA
PANAMEDIC GAUZE SPONGES
FDA 510(k)
FDA Unclassified
·Unknown
Pro Advantage
FDA UDI
NATIONAL DISTRIBUTION & CONTRACTING, INC.·M220P8500932·Pro Advantage Electrode Foam 2 3/4 Round 4PK
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994726094·FENESTRATED SCREW 1850093 TRAY
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209114115·
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1
FDA 510(k)
FDA Class 2
·Cardiovascular
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·B&L THERMA-ZYME, FIZZICLEAN
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·B&L THERMA-ZYME, FIZZICLEAN
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·B&L THERMA-ZYME, FIZZICLEAN
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·B&L THERMA-ZYME, FIZZICLEAN
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·B&L THERMA-ZYME, FIZZICLEAN
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·B&L THERMA-ZYME, FIZZICLEAN
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·B&L RENU ENZYMATIC CLEANING TABLET
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·B&L THERMA-ZYME, FIZZICLEAN
Accessories, Soft Lens Products
FDA Pre-Market Approval
FDA Class 2
·B&L THERMA-ZYME, FIZZICLEAN
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 4, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 26, 2012
AC POWER MODULE
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·September 21, 2010
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
NIM Vital Nerve Monitoring systems (all serial numbers manufactured) with NIM Vital System versions: v1.0.0, v1.1.1, v1.3.2, v1.4.3. NIM Vital Nerve Integrity Monitor with below product descriptions. 1. CONSOLE NIM4CM01 NIM 4.0, Model Number: NIM4CM01. 2. CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED, Model Number: NIM4CM01RF, 3. PATIENT INTERFACE NIM4CPB1 NIM 4.0, Model Number: NIM4CPB1, 4. PATIENT INTFC NIM4CPB1RF NIM 4.0 REFURB, Model Number: NIM4CPB1RF, 5. SOFTWARE NIM4SWU143 UPGRADE V1.4.3, Model Number: NIM4SWU143
FDA Enforcement
Class I
·Ongoing·Medtronic Xomed, Inc.·July 31, 2024