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Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRCUMCISION TRAY CIT2470 CIRC TRAY W/UNIVERSAL CLAMP CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2510 CIRCUMCISION TRAY W/1.1 CM CLAMP CIT2530A CIRCUMCISION TRAY CIT2545 CIRCUMCISION TRAY CIT2630 CIRCUMCISION TRAY CIT2705 CIRCUMCISION TRAY CIT2730 CIRCUMCISION TRAY CIT3000 CIRCUMCISION TRAY CIT3010 CIRCUMCISION TRAY CIT3100 CIRCUMCISION TRAY CIT3145 UNIVERSAL CIRCUMCISION TRAY W/OUT CLAMP CIT3310 RECYCLABLE CIRCUMCISION TRAY CIT3315 CIRCUMCISION TRAY CIT3345 CIRCUMCISION TRAY CIT3465 L&D CIRCUMCISION SET CIT3690 CIRCUMCISION TRAY CIT3720 CIRCUMCISION TRAY CIT3725 CIRCUMCISION TRAY CIT3730 CIRCUMCISION TRAY CIT3800 CIRCUMCISION TRAY CIT3800 CIRCUMCISION TRAY CIT3835A UNIVERSAL CIRC TRAY W/SURGICAL INST CIT3865 CIRCUMCISION SET W/CLAMP AND 1.1 BELL CIT3890 CIRCUMCISION TRAY CIT4025 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4100 CIRCUMCISION TRAY - NO CLAMP CIT4100 CIRCUMCISION TRAY - NO CLAMP CIT4135 CIRCUMCISION TRAY CIT4140 CIRCUMCISION TRAY CIT4140 CIRCUMCISION TRAY CIT4180 CIRCUMCISION TRAY CIT4230 CIRCUMCISION TRAY CIT4260 CIRCUMCISION SET W/1.1 CLAMP CIT4335 CIRCUMCISION TRAY CIT4370 CIRCUMCISION TRAY CIT4400 CIRCUMCISION TRAY FOR CIRC CLAMP CIT4405 CIRCUMCISION TRAY FOR MOGEN CLAMP CIT4525 CIRCUMCISION TRAY CIT4775 CIRCUMCISION TRAY CIT4835 CIRCUMCISION TRAY WITH 1.3 CIRCLAMP CIT4840 CIRCUMCISION TRAY WITH 1.1 CIRCLAMP CIT4855 1.3 CIRCUMCISION TRAY CLAMP & BELL CIT5030 CIRCUMCISION TRAY CIT5135 UNIVERSAL CIRCUMCISION TRAY CIT5210 CIRCUMCISION TRAY CIT5290 UNIVERSAL CIRCUMCISION TRAY CIT5290 UNIVERSAL CIRCUMCISION TRAY CIT5295 CIRCUMCISION TRAY CIT5300 CIRCUMCISION TRAY CIT5340 CIRCUMCISION TRAY CIT5370 1.3 CIRCUMCISION TRAY CIT5375 CIRCUMCISION TRAY CIT5400 CIRCUMCISION TRAY CIT5460 UNIVERSAL CIRCUMCISION TRAY CIT5470 CIRCUMCISION TRAY W/1.1 BELL & CLAMP CIT5475 CIRCUMCISION TRAY CIT5495 CIRCUMCISION TRAY WITH UNIVERSAL CLAMP CIT5560 CIRC TRAY CIT5580 CIRCUMCISION KIT CIT5615 CIRCUMCISION TRAY CIT5615 CIRCUMCISION TRAY CIT5700 1.3 CIRCUMCISION KIT CIT5735 CIRCUMCISION TRAY CIT5745 CIRCUMCISION TRAY CIT5850 CIRCUMCISION TRAY CIT5955 CIRC TRAY WITH PVP AND SOFT STRAPS CIT6015 CIRCUMCISION TRAY CIT6050 CIRCUMCISION TRAY CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP CIT6120 CIRCUMCISION TRAY CIT6200 CIRCUMCISION TRAY CIT6355 UNIVERSAL CIRCUMCISION TRAY CIT6365 CIRCUMCISION TRAY CIT6445 CIRCUMCISION TRAY CIT6545 CIRC TRAY CIT6560 CIRCUMCISION TRAY CIT6610A CIRCUMCISION TRAY NEWBORN NURSERY CIT6620 CIRCUMCISION TRAY CIT6635 CIRCUMCISION TRAY CIT6670 CIRCUMCISION TRAY CIT6685 CIRCUMCISION TRAY CIT6750 CIRCUMCISION TRAY CIT6860 CIRCUMCISION TRAY CIT6880 CIRCUMCISION TRAY CIT6920 NICU CIRCUMCISION TRAY W/OUT CLAMP CIT6935 CIRCUMCISION TRAY

FDA Enforcement
Class II ·Terminated·Centurion Medical Products Corporation·February 12, 2020

Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRCUMCISION TRAY CIT2470 CIRC TRAY W/UNIVERSAL CLAMP CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2510 CIRCUMCISION TRAY W/1.1 CM CLAMP CIT2530A CIRCUMCISION TRAY CIT2545 CIRCUMCISION TRAY CIT2630 CIRCUMCISION TRAY CIT2705 CIRCUMCISION TRAY CIT2730 CIRCUMCISION TRAY CIT3000 CIRCUMCISION TRAY CIT3010 CIRCUMCISION TRAY CIT3100 CIRCUMCISION TRAY CIT3145 UNIVERSAL CIRCUMCISION TRAY W/OUT CLAMP CIT3310 RECYCLABLE CIRCUMCISION TRAY CIT3315 CIRCUMCISION TRAY CIT3345 CIRCUMCISION TRAY CIT3465 L&D CIRCUMCISION SET CIT3690 CIRCUMCISION TRAY CIT3720 CIRCUMCISION TRAY CIT3725 CIRCUMCISION TRAY CIT3730 CIRCUMCISION TRAY CIT3800 CIRCUMCISION TRAY CIT3800 CIRCUMCISION TRAY CIT3835A UNIVERSAL CIRC TRAY W/SURGICAL INST CIT3865 CIRCUMCISION SET W/CLAMP AND 1.1 BELL CIT3890 CIRCUMCISION TRAY CIT4025 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4080 CIRCUMCISION TRAY CIT4100 CIRCUMCISION TRAY - NO CLAMP CIT4100 CIRCUMCISION TRAY - NO CLAMP CIT4135 CIRCUMCISION TRAY CIT4140 CIRCUMCISION TRAY CIT4140 CIRCUMCISION TRAY CIT4180 CIRCUMCISION TRAY CIT4230 CIRCUMCISION TRAY CIT4260 CIRCUMCISION SET W/1.1 CLAMP CIT4335 CIRCUMCISION TRAY CIT4370 CIRCUMCISION TRAY CIT4400 CIRCUMCISION TRAY FOR CIRC CLAMP CIT4405 CIRCUMCISION TRAY FOR MOGEN CLAMP CIT4525 CIRCUMCISION TRAY CIT4775 CIRCUMCISION TRAY CIT4835 CIRCUMCISION TRAY WITH 1.3 CIRCLAMP CIT4840 CIRCUMCISION TRAY WITH 1.1 CIRCLAMP CIT4855 1.3 CIRCUMCISION TRAY CLAMP & BELL CIT5030 CIRCUMCISION TRAY CIT5135 UNIVERSAL CIRCUMCISION TRAY CIT5210 CIRCUMCISION TRAY CIT5290 UNIVERSAL CIRCUMCISION TRAY CIT5290 UNIVERSAL CIRCUMCISION TRAY CIT5295 CIRCUMCISION TRAY CIT5300 CIRCUMCISION TRAY CIT5340 CIRCUMCISION TRAY CIT5370 1.3 CIRCUMCISION TRAY CIT5375 CIRCUMCISION TRAY CIT5400 CIRCUMCISION TRAY CIT5460 UNIVERSAL CIRCUMCISION TRAY CIT5470 CIRCUMCISION TRAY W/1.1 BELL & CLAMP CIT5475 CIRCUMCISION TRAY CIT5495 CIRCUMCISION TRAY WITH UNIVERSAL CLAMP CIT5560 CIRC TRAY CIT5580 CIRCUMCISION KIT CIT5615 CIRCUMCISION TRAY CIT5615 CIRCUMCISION TRAY CIT5700 1.3 CIRCUMCISION KIT CIT5735 CIRCUMCISION TRAY CIT5745 CIRCUMCISION TRAY CIT5850 CIRCUMCISION TRAY CIT5955 CIRC TRAY WITH PVP AND SOFT STRAPS CIT6015 CIRCUMCISION TRAY CIT6050 CIRCUMCISION TRAY CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP CIT6090 OSF CIRC TRAY WITH 1.1 CLAMP CIT6120 CIRCUMCISION TRAY CIT6200 CIRCUMCISION TRAY CIT6355 UNIVERSAL CIRCUMCISION TRAY CIT6365 CIRCUMCISION TRAY CIT6445 CIRCUMCISION TRAY CIT6545 CIRC TRAY CIT6560 CIRCUMCISION TRAY CIT6610A CIRCUMCISION TRAY NEWBORN NURSERY CIT6620 CIRCUMCISION TRAY CIT6635 CIRCUMCISION TRAY CIT6670 CIRCUMCISION TRAY CIT6685 CIRCUMCISION TRAY CIT6750 CIRCUMCISION TRAY CIT6860 CIRCUMCISION TRAY CIT6880 CIRCUMCISION TRAY CIT6920 NICU CIRCUMCISION TRAY W/OUT CLAMP CIT6935 CIRCUMCISION TRAY

FDA Recall
Terminated ·Centurion Medical Products Corporation·Product code OHG·December 11, 2019

Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.

FDA Recall
Terminated ·Materialise N.V. 15 Technologielaan Heverlee Belgium·Product code OSF·September 23, 2015

Natural-Knee¿ Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5

FDA Enforcement
Class II ·Terminated·Zimmer, Inc.·March 26, 2014

Natural-Knee Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5

FDA Recall
Terminated ·Zimmer, Inc.·Product code JWH·February 25, 2014

Multi Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing 2 Multi Absorbers)

FDA Recall
Terminated ·Datex-Ohmeda·Product code BSF·February 12, 2003

The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems --- Manufactured in the United Kingdom for: Intersurgical Incorporated --- 417 Electronics Parkway, Liverpool, NY 13088. Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane.

FDA Recall
Terminated ·Intersurgical Inc·Product code BSF·February 9, 2011

Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.

FDA Recall
Terminated ·GE Healthcare, LLC·Product code BSF·September 19, 2013

GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.

FDA Recall
Terminated ·Datex Ohmeda, Inc·Product code BSF·July 24, 2007

Getinge MCC Flow i Disposable CO2 absorber, used in anesthesia systems.

FDA Recall
Terminated ·GETINGE US SALES LLC·Product code BSF·July 22, 2019

PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.

FDA Recall
Terminated ·Gsi Group Inc·Product code DSF·December 2, 2015

Multi Absorbers, reference number 8003138

FDA Recall
Terminated ·Datex-Ohmeda·Product code BSF·February 12, 2003

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

FDA Enforcement
Class II ·Terminated·Mizuho OSI·February 20, 2013

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 Enforcement
Class II ·Terminated·Mizuho OSI·February 17, 2016

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 Enforcement
Class II ·Terminated·Mizuho OSI·April 26, 2017

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 Enforcement
Class II ·Terminated·Mizuho OSI·October 21, 2020

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