119 results · 11ms · Sources: EU EUDAMED, US FDA

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Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures.

FDA Recall
Terminated ·Medtronic Xomed, Inc.·Product code MMO·July 9, 2013

Diagnostics Chemical Limited Iron Assay Catalog Number: 102-25 For the In Vitro quantitative determination of iron in serum.

FDA Recall
Terminated ·Diagnostic Chemicals, Ltd.·Product code JMO·March 14, 2008

Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

FDA Recall
Terminated ·Ace Surgical Supply Co., Inc.·Product code EMO·March 28, 2018

VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code JMO·May 24, 2016

Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in vitro diagnostic test intended to quantitatively measure Total Iron Binding capacity in human serum and plasma.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JMO·December 16, 2009

Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JMO·December 20, 2012

UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma on Beckman Coulter AU analyzers.

FDA Recall
Terminated ·Beckman Coulter Inc.·Product code JMO·August 18, 2020

Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Manufactured for Sims Portex, Inc., Fort Meyers, FL, Made in Mexico.

FDA Recall
Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

Circuit-Unilimb, Adult, 1M (40''), Disposable, Clean Non-sterile, Adult Anesthesia Circuit, Part Numbers DYNJAAF4000, DYNJAAF6225, and DYNJAAF6261. Manufactured for Medline Industries, Inc., Mundelein, IL 60060, Made in Mexico.

FDA Recall
Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

Coaxial Rebreathing Circuit 1.5 M and 2 M, single use, Part nubers T61500 (1.5 M) and T18116 (2 M). Manufactured for GEO Logistics, Copenhagen, Denmark, Made in Mexico

FDA Recall
Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

Circuit-Nexus, Adult, single use, Part Numbers: N7A110CG06, N4A100CE06, C4N0121000, 60010-1B, and 40301-1-2730. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.

FDA Recall
Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

Circuit-Unilimb, Pediatric, 1M (40''), Disposable, Clean Non-Sterile, Pediatric Anesthesia Circuit, Part Number DYNJAPF4000. Manufactured for Medline Industries, Inc., Mundelein, IL 60060, Made in Mexico.

FDA Recall
Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

Meridian Nexus, single use. Part Numbers: C4N00D001, 15867, 15880, 15880-30, 12000-1, 40000-1, 40200-1, 40301-1, 40301-1ML, 40301-1-13, 40301-1-13MM, 40301-1-24, 40301-1-30, 40302-1C24, 60000-1, 60201-1, 60300-M, 60301-1, 60301-1-24, 60302-1HM30-70, 60301-13042M, 72300-1-4-30-70, 72301-1, 72000-50-7589, 60301-1304042, and 72000-75. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.

FDA Recall
Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

Meridian Nexus- Pediatric, single use Part Numbers 60211-1304042, 60111-1, 60111-1MN, 40111-13042, 15900, 40010-1, and 40111-1. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.

FDA Recall
Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

Circuit- Matching Kit, 40'' Adult, 3L LPF, single use, Part Numbers RP640F0D0 and RP660F0D0. Manufactured for Pall Life Sciences, Ann Arbor, Michigan. Made in Mexico.

FDA Recall
Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

Unilimb Circuit 40'' Bulk, single use Part Number 225-4400-300. Manufactured for MMS Sales Corporation, 218 Highline Road, Pharr, Texas 78577, Made in Mexico.

FDA Recall
Terminated ·MMS Sales Corp·Product code CAI·February 21, 2005

STAR S4 IR Excimer Laser System; Software Version 5.15 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

FDA Recall
Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

STAR S4 IR Excimer Laser System; Software Version 5.22 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

FDA Recall
Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

STAR S4 IR Excimer Laser System; Software Version 5.21 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

FDA Recall
Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011

STAR S4 IR Excimer Laser System; Software Version 5.18 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

FDA Recall
Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 18, 2011