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

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ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping bone including spine and cranium.

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·August 5, 2015

ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting shaping bone including spine and cranium.

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·August 5, 2015

ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.

FDA Enforcement
Class II ·Terminated·The Anspach Effort, Inc.·August 5, 2015

AAMI 3 NON-REINF SURG GOWN LG 2 TWL, Item Code ASG9515

FDA Enforcement
Class II ·Terminated·Cardinal Health·February 12, 2020

ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting shaping bone including spine and cranium.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping bone including spine and cranium.

FDA Recall
Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

FDA Recall
Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

FDA Recall
Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

FDA Recall
Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

FDA Recall
Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

FDA Recall
Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004

FDA Enforcement
Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880

FDA Recall
Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JGJ·November 13, 2020

Abbott Clinical Chemistry AEROSET c8000 Magnesium, List numbers 7D70-01, 7D70-20, 7D70-30.

FDA Recall
Terminated ·Abbott Laboratories Diagnostic Div·Product code JGJ·December 22, 2003

VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code JGJ·June 12, 2013

Magnesium on RX Imola analyser IVD

FDA Recall
Terminated ·Randox Laboratories, Limited Ardmore 55 The Diamond Road Crumlin United Kingdom·Product code JGJ·April 14, 2016

ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone

FDA Recall
Terminated ·Tosoh Bioscience Inc·Product code CGJ·March 5, 2018

ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination of follicle-stimulating hormone (FSH) in serum using the ADVIA Centaur and ADVIA Centaur XP systems

FDA Recall
Terminated ·Siemens Healthcare Diagnostics, Inc·Product code CGJ·August 7, 2012

Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments.

FDA Recall
Terminated ·Selectivemed Components Inc·Product code EGJ·March 15, 2005