14 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
FDA 510(k)
FDA Class 2
·Cardiovascular
SCANLAN®
FDA UDI
SCANLAN INTERNATIONAL INC·00846159007961·Baby VascularClamp With Angled Atraumatic Jaw
Metal Custom Rx
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746102981·BRACKET MEDIUM TWIN 022 TQ=5 A=0 R=0 PROFILE=HP...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450141892·
CB10-4E Ultrasonic Transducer(FDA)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904088198·
LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Dental
HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G
FDA 510(k)
FDA Class 2
·Microbiology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·March 13, 2013
UNKNOWN DEPUY GLENOID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWS·February 18, 2011
SNP UNICORTICAL SCREW
FDA Adverse Event
Injury
·DEPUY ACE S.A. 'R.L.·Product code LXT·February 20, 2008
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
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