18 results · 32ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile

FDA Enforcement
Class II ·Terminated·Baxter Corporation Englewood·December 31, 2014

Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile

FDA Recall
Terminated ·Baxter Corporation Englewood·Product code KYX·December 4, 2014

Raymond Laser alignment guide - Model #1096597/002 Red Laser. Intended to assist operators in performing material handling activities such as storing and retrieving pallets and material in and on racking projecting a line onto a pallet or other material storage medium for assisting the operator in determining the position of the powered industrial truck forks with respect to load.

FDA Recall
Terminated ·The Raymond Corporation S Canal·Product code RER·November 28, 2011

GE Optional Laser Centering Device X-ray generator.

FDA Recall
Terminated ·Product code RER·November 10, 2014

Raymond Laser alignment guide - Model #1096597/001 Green Laser. Intended to assist operators in performing material handling activities such as storing and retrieving pallets and material in and on racking projecting a line onto a pallet or other material storage medium for assisting the operator in determining the position of the powered industrial truck forks with respect to load.

FDA Recall
Terminated ·The Raymond Corporation S Canal·Product code RER·November 28, 2011

ASP Automatic Endoscope Reprocessor, AER Plus Product Code 20300 and AER with printer Product Code 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.

FDA Recall
Terminated ·Advanced Sterilization Products·Product code FEB·September 11, 2008

ASP Automatic Endoscope Reprocessor (AER), Product Code: 20300 & 20301 The AER is a machine designed to automatically wash and high-level disinfect flexible, submersible fiberoptic or video endoscopes.

FDA Recall
Terminated ·Advanced Sterilization Products·Product code KOG·February 19, 2010

The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.

FDA Recall
Terminated ·Custom Ultrasonics, Inc.·Product code NVE·May 6, 2016

OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

FDA Enforcement
Class II ·Terminated·Olympus Corporation of the Americas·October 26, 2016

The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.

FDA Enforcement
Class II ·Terminated·Custom Ultrasonics, Inc.·July 13, 2016

Euflexxa (1% sodium hyaluronate). Pre-filled syringe, Rx only, 3 syringes per carton; Manufactured by Ferring Pharmaceuticals In, Parsippany, NJ 07054; Manufactured by Bio-Technology General (Israel Ltd. Be er Tuvia, Kiryat Malachi 83104 Israel. Indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics.

FDA Recall
Terminated ·Ferring Pharmaceuticals Inc·Product code MOZ·April 16, 2010

DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope.

FDA Recall
Terminated ·Minntech Corp·Product code FEB·June 15, 2010

Flexible Intubation Fiberscope, Model # 11301AB1

FDA Recall
Terminated ·Karl Storz Endoscopy·Product code EOQ·April 24, 2019

GE Healthcare OEC 9900 mobile fluoroscopic x-ray system

FDA Recall
Terminated ·OEC Medical Systems, Inc·Product code JAA·December 14, 2007

Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.

FDA Recall
Terminated ·Abbott Laboratories, Inc·Product code DER·May 16, 2018

GelPOINT Path Transanal Procedural Pack with Epix Electrosurgical L-Hook with Smoke Evacuation, 4x5.5cm and 5mm x 42cm REF TA211 Product Usage: The GelPOINT Path Transanal Access Platform is indicated for multiple instrument or camera access through the anus to perform various diagnostic and/or therapeutic procedures by using additional instruments.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code FER·December 12, 2018

Clinical Chemistry Apolipoprotein A1, List Number 9D92-20

FDA Recall
Terminated ·Abbott Laboratories Diagnostic Div·Product code DER·November 10, 2005

OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector

FDA Recall
Terminated ·Olympus Corporation of the Americas·Product code FEB·June 23, 2016