18 results · 22ms · Sources: EU EUDAMED, US FDA

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IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE

FDA 510(k)
FDA Class 2 ·Physical Medicine

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809871241·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND OPEN T...

GELBISH VASCULAR DILATOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP

FDA 510(k)
FDA Class 2 ·Cardiovascular

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES (DBA ANGIOTECH)·Product code GAW·April 3, 2008

CONTOUR THREAD

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·February 15, 2008

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·February 12, 2013

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAP·September 16, 2008

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·September 23, 2009

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·May 15, 2008

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Injury ·SURGICAL SPECIALITIES CORP·Product code GAW·February 25, 2014

ACCURUS VITRECTOMY SYSTEM

FDA Adverse Event
Injury ·ALCON LENSX, INC.·Product code HQC·March 18, 2013

VITALITY DR HE

FDA Adverse Event
Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

INCEPTA

FDA Adverse Event
Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 6, 2011

CONTOUR THREAD OR CONTOUR THREADS

FDA Adverse Event
Other ·SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)·Product code GAW·October 22, 2009

PKG, BLUNT FORCEPS, BLUNT, SERRATED, SPOON, P/N 0250080313. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

FDA Enforcement
Class II ·Terminated·Stryker Endoscopy·December 24, 2014

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024