22 results
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20ms
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Sources: EU EUDAMED, US FDA
HEMOSTATIC/TUBE OCCLUDING FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013998·OA Knee Brace, Single Upright, Right
ACUMED
FDA UDI
Acumed LLC·10806378042164·Ankle Plate Tray Lid Assembly
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591014001·OA Knee Brace, Single Upright, Left
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306835643·Rubinstein Diamond, 11G x 22cm, Straight, Luer,...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306835650·Pre-Assembled Rubinstein Diamond, 11G x 22cm, S...
RESTORE PRIME
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 13, 2013
OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMEDA PLATINUM BREAST PUMP
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 10, 2015
RESTORE PRIME
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 25, 2012
CODMAN MICROSENSOR BASIC KIT
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code GWM·January 5, 2021
BIODESIGN POSTERIOR PELVIC GLOOR GRAFT
FDA Adverse Event
Injury
·COOK BIOTECH, INC.·Product code PAJ·April 3, 2014
FORCE FX
FDA Adverse Event
Injury
·COVIDIEN LP·Product code GEI·October 16, 2012
VALIANT CAPTIVIA - CW
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·May 27, 2015
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 10, 2019
See Luer Cap Set, MPC-130, set, administration, intravascular
FDA Recall
Open, Classified
·Molded Products Inc·Product code FPA·February 17, 2026
Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration.
FDA Recall
Terminated
·Precision Dynamics Corporation·Product code FZZ·July 10, 2013
Stryker brand Cart with Isolation Transformer, Model Numbers: 240-099-001, 240-099-001K, 240-099-011, 240-099-011K, 240-099-020, 240-099-020K, 240-099-050, 240-099-072. 240-099-001, 240-099-001K, 240-099-011, 240-099-011K, 240-099-020, 240-099-020K, 240-099-050, 240-099-072, Product is manufactured and distributed by Stryker Endoscopy San Jose, CA The product is indicated for use in the carts include an isolation transfer and a power cord for connecting the transformer to an electrical outlet as means of providing power to the cart for the equipment it houses.
FDA Recall
Terminated
·Stryker Endoscopy·Product code GCJ·April 16, 2010
Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the affected breast pumps were sold in the following configurations: a) article 57027 - Kit PNSA Shoulder Bag; b) article 57027T - Kit PNSA Shoulder Bag Tagged; c) article 57036T - Kit PNSA The Metro Bag Tagged; d) article 57043 - PNSA without kit; e) article 57062 - Kit PNSA Backpack; f) article 57062-03 - Kit PNSA Backpack CA/3; g) article 57062T - Kit PNSA Backpack Tagged; h) 57102 - Motor Replacement PNSA Backpack 57062; i) 57103 - Motor Replacement PNSA Shoulder Bag 57027 Intended use: A powered breast pump for the removal, collection and storage of mother's breast milk.
FDA Recall
Terminated
·Medela Inc·Product code HGX·January 10, 2011