28 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONTOUR HA COATED RECONSTRUCTION RING
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00885074037172·BONE SCREW 7040680 ILIAC 6.5X80 TI
Pneumosure
FDA UDI
STRYKER CORPORATION·07613327055641·[High Flow Insufflator, Do not use if package ...
CT SPACER
FDA 510(k)
FDA Class 2
·Anesthesiology
VISION ESTHETIC PORCELAIN SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TESS GLENOID REVERSE HEAD DIAMETER 36
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code KWS·October 27, 2016
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 30, 2009
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·April 30, 2009
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009
SWEET PICOTIP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 6, 2011
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 8, 2013
ASCENSIA BREEZE2 TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·May 8, 2008
BD¿ LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·October 24, 2022
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·March 12, 2009
BD¿ LUER-LOK SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 30, 2022
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·October 31, 2008
Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
FDA Recall
Terminated
·Stryker Corporation·Product code HIF·March 7, 2019
Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
FDA Enforcement
Class II
·Terminated·Stryker Corporation·June 12, 2019
Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
FDA Enforcement
Class II
·Ongoing·ROi Consolidated Service Center (CSC)·August 14, 2019
Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
FDA Enforcement
Class II
·Ongoing·ROi Consolidated Service Center (CSC)·August 14, 2019