28 results · 23ms · Sources: EU EUDAMED, 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