14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ocata Anterior Cervical System
FDA 510(k)
FDA Class 2
·Orthopedic
QCT Pro Asynchronous Calibration Module, CliniQCT
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...
Oticon
FDA UDI
Oticon A/S·05707131318725·OPN 2, MRITE 312 2.4G NFM PB C093
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10885425793174·PAIN TRAY
CLINICAL ELECTRONIC THERMOMETER, MODELS TP11403 THROUGH TP11413
FDA 510(k)
FDA Class 2
·General Hospital
YOLO CURVE
FDA 510(k)
FDA Class 2
·Physical Medicine
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·May 24, 2013
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 20, 2011
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·September 11, 2008
PRESIDIO 10 CERE 6MMX26CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·May 10, 2021
(17-0342) ANK IMPL A8 D3.5 MM/L8 MM(IMPLANTS)
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·June 18, 2021
(17-0342) ANK IMPL A8 D3.5 MM/L8 MM(IMPLANTS)
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 3, 2021
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12343A Meldrum Pack AMS12359B Neuro Pack AMS12520 Total Hip Pack AMS12608 Extremity Pack AMS12610 Shoulder Pack AMS12636 Dr. Thompson Pack AMS12689A Custom Pack AMS12753 Breast Pack AMS12754 Abdominoplasty Pack AMS12769 Minor Pack AMS12926 Shoulder Pack AMS12927 Retina Pack AMS13428 Hand Pack AMS2120D Plastics Tray AMS2890(B Basic Biopsy Tray AMS3824(A Myelogram Tray - RX AMS4022F Lami Pack AMS4371C Lasik Eye Pack AMS4372 Plastic Eye Pack AMS4599(C Spine Pack AMS4670B Upper Extremity Pack AMS4766C Shoulder Arthroscopy Pack AMS4952A Vitrectomy Pack - RX AMS5697A EVLT Pack AMS5819B Ortho Major Pack AMS5887A CARS Pack AMS6112A Minor Extremity Pack AMS6112B Minor Extremity Pack AMS6160C Hip Pack AMS6277A Procurement Bundle - Pack A/B/C AMS6728A Breast Pack AMS7463B Retrieval Pack AMS7971 TVOR Pack AMS8094 Plastics Eye Pack AMS8664B Spinal Pack AMS8989 Hysteroscopy Pack AMS9118 Retrieval Pack AMS9197 Arthroscopy Pack AMS9435 Foot Pack AMS9487A Toy Hip Pack AMS9487B Total Hip Pack CMP1018G Cataract Kit - Dr. Wright PSS1838B Medical Imaging Kit VPP1020A Custom Dental Pack VPP1023B OR Implant Bundle Pack WAL1207C Minor Pack
FDA Enforcement
Class II
·Ongoing·Windstone Medical Packaging, Inc.·January 11, 2023
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. 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