14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
GEN-PROBE APTIMA COMBO 2 ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Premier Elevator
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783004212·ELEVATOR POTTS 2
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159022780·Puskas™ Jacobson Micro Needle Holder
QUASAR
FDA UDI
Modus Medical Devices Inc·G34350033950·RESP-Cedar Ion Chamber Holder(drilled)
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code JTC·August 18, 2000
EINSTEIN PROCESSING AND REVIEW WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
MODEL 30 CLASSIC PNEUMATONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
ZPower Rechargeable System for Hearing Aids
FDA UDI
ZPOWER, LLC·00811204030218·Charger for ZPower Rechargeable System for Hear...
DISTRACTOR TIP FOR MATRIX
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·February 28, 2013
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·March 1, 2011
VENATECH LP VENA CAVA FILTER
FDA Adverse Event
Injury
·B BRAUN MEDICAL SAS·Product code DTK·February 22, 2008
smiths medical PORTEX Tracheal Tube Exchange Guide, 10Ch x 70cm, REF 14-504-76
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024