18 results · 13ms · Sources: EU EUDAMED, US FDA

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Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for fracture fixation, fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone.

FDA Recall
Terminated ·Smith & Nephew, Inc.·Product code OSN·December 13, 2017

BNX Fine Need Aspiration System (22GA); Material/Part#: DSN-22-01

FDA Recall
Terminated ·Medtronic·Product code FCG·February 8, 2017

BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01

FDA Recall
Terminated ·Medtronic·Product code FCG·February 8, 2017

(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.

FDA Recall
Terminated ·BSN Medical Inc·Product code FQM·February 1, 2022

3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136

FDA Recall
Terminated ·3M Company Health Care Business 3m Center·Product code KGX·November 21, 2019

VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).

FDA Recall
Terminated ·Sequent Medical Inc·Product code KRA·September 23, 2016

Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.

FDA Recall
Terminated ·Mizuho OSI·Product code JEA·December 17, 2012

216 Wilson Frame Pads, Model # 5319-37; Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G. General and Plastic Surgery: These pads are used as a component of the Wilson Frames, which support the torso of a prone patient during spine surgery. The pads are supplied with the frames and as replacements.

FDA Recall
Terminated ·Mizuho OSI·Product code FWZ·March 28, 2017

Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.

FDA Recall
Terminated ·Mizuho OSI·Product code GDC·December 14, 2015

Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.

FDA Recall
Terminated ·Mizuho OSI·Product code JEA·October 14, 2019

Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System

FDA Recall
Terminated ·Beckman Coulter Inc·Product code CFR·April 3, 2008

Access and Access 2 Immunoassay System

FDA Recall
Terminated ·Beckman Coulter Inc·Product code CGN·April 3, 2008

UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical System

FDA Recall
Terminated ·Beckman Coulter Inc·Product code JJE·April 3, 2008

SYNCHRON LXi 725 System

FDA Recall
Terminated ·Beckman Coulter Inc·Product code JGS·April 3, 2008

200996-Cable Assembly, Hybrid Extended Length, 200997 Cable Assembly, Hybrid, Guidance Module, 200998 Cable Assembly, Hybrid, UI Panel Subcomponents for the 203000 RIO STANDARD SYSTEM Manufactured by: MAKO Surgical, Corp. Fort Lauderdale, FL. All three cables are integral components and are not purchased separately. However, 200996-Cable Assembly is the only cable visible. This cable is labeled: 200996-REV-1, KSM 390634-1, SN 000001. 200997 and 200998 Cable Assembly are not visible . The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

FDA Recall
Terminated ·Mako Surgical Corporation·Product code HAW·July 17, 2009

BD, Salmonella Somatic Polyvalent Antiserum (A,B,D)

FDA Recall
Terminated ·BD Diagnostic Systems·Product code GSN·October 20, 2004

Millipore Millex Syringe Filter Unit, 33 mm Durapore PVDF 0.22um, Sterile, 50 Filters per box. Catalog Number: SLGVM33RS.

FDA Recall
Terminated ·Millipore Corporation·Product code BSN·November 25, 2009

BD, Salmonella Flagellar Polyvalent Antiserum (a,b,d)

FDA Recall
Terminated ·BD Diagnostic Systems·Product code GSN·October 20, 2004