18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
SUTURTEK FASTCLOSE SUTURING DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756001649·Knee Immobilizer
Asnis
FDA UDI
Stryker GmbH·07613154631360·CANNULATED SCREW
BIO-ABSORBABLE CORKSCREW MODEL AR-1920B
FDA 510(k)
FDA Class 2
·Orthopedic
UMBICUT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ZEPHIR® ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·April 24, 2014
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FPA·June 11, 2025
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·February 18, 2011
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWQ·January 3, 2017
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·September 20, 2013
EZ-28 DELIVERY SYSTEM
FDA Adverse Event
Injury
·BAUSCH & LOMB·Product code MSS·March 27, 2013
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 7, 2011
S.M.A.R.T. NITINOL STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code FGE·April 16, 2008
BIO-CORKSCREW SUTURE ANCHOR
FDA Adverse Event
Injury
·ARTHREX, INC.·Product code MAI·February 21, 2007
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code KWQ·October 12, 2011
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.
FDA Enforcement
Class II
·Terminated·Ondamed Inc·May 16, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018