45 results · 12ms · Sources: EU EUDAMED, US FDA

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QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. Product Usage: The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only, for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed, edited, distributed electronically or printed. No real time monitoring or alarm capability is provided.

FDA Recall
Terminated ·Qrs Diagnostic·Product code LOS·February 16, 2012

Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument which is used over the guide wire to prepare for adequate space in the cortical bone rim to sink the screw head in to bones/tissues for different Foot, Ankle and Hand implant systems. The instrument is used in several Normed implant systems. The instrument is used to avoid soft tissue irritation

FDA Recall
Terminated ·Product code HTT·May 11, 2017

CBS micro, countersink, cannulated, AO, Item Number 503004541

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019

CBS high, countersink, cannulated, AO, Item Number ST503004542

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019

CBS micro, countersink, cannulated, AO, Item Number ST503004541

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019

CBS 7.5 tap, cannulated, AO, Item Number 503002041

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWX·April 8, 2019

CBS high, countersink, cannulated, AO, Item Number 503004542

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019

CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019

CBS micro, countersink, cannulated, round-shaft, Item Number 503004341

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019

CBS high, countersink, cannulated, round-shaft, Item Number 503004342

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019

CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019

CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351

FDA Recall
Terminated ·Zimmer GmbH Sulzerallee 8 Winterthur Switzerland·Product code HWW·April 8, 2019

Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden

FDA Recall
Terminated ·MAQUET Inc.·Product code BSZ·July 10, 2007

Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. The Safety Alert action targets customers with Unit Serial numbers 24578 and lower. Manuf. Maquet Critial Care AB, SE-171 95 Solna, Sweden.

FDA Recall
Terminated ·Maquet Inc·Product code CBK·January 3, 2005

TWIST D 28X150MM CBS 45 Cann 14 MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

FDA Recall
Terminated ·Product code LXH·June 27, 2016

HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9016, Size (Fr) 16, # Eyelets 4, 10 per case

FDA Recall
Terminated ·Atrium Medical Corporation·Product code GBS·May 12, 2008

HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9120, Size (Fr) 20, # Eyelets 4, 10 per case

FDA Recall
Terminated ·Atrium Medical Corporation·Product code GBS·May 12, 2008

VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson company --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA --- VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems. --- Product codes: 6801895 (60 slide count); 6802469 (18 slide count) --- indicated to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems.

FDA Recall
Terminated ·Ortho-Clinical Diagnostics·Product code LBS·February 2, 2012

HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9040, Size (Fr) 40, # Eyelets 6, 10 per case

FDA Recall
Terminated ·Atrium Medical Corporation·Product code GBS·May 12, 2008

HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of HDL-cholesterol concentration in serum and plasma.

FDA Recall
Terminated ·Roche Diagnostics Operations, Inc.·Product code LBS·May 7, 2015