45 results · 13ms · Sources: EU EUDAMED, US FDA

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life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.

FDA Recall
Terminated ·Exocomm Tech Grp·Product code MKJ·September 3, 2007

life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N:9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.

FDA Recall
Terminated ·Exocomm Tech Grp·Product code MKJ·September 3, 2007

ORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high tibial osteotomies.

FDA Recall
Terminated ·Corflex·Product code ITQ·November 12, 2015

VaccZyme Human Anti-Haemophilus influenza type b Enzyme Immunoassay Kit For in vitro diagnostic use, Product Code: MK016 - Product Usage: This assay is designed for the in vitro measurement of specific IgG antibodies against Haemophilus influenzae type b (Hib) capsular polysaccharide, present in human serum. Sufficient materials are supplied to allow a maximum of 41 samples to be tested in duplicate, with a calibration curve and two controls.

FDA Recall
Terminated ·The Binding Site Group, Ltd.·Product code GRP·August 12, 2018

Power Supply under the following brand names: a) RP, Power Supply Assembly model number H3600-015, and b) RP, Wiring Harness, Lamp Holder model number H3600-020. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall
Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

Non-continuous ventilator accessories under the following brand names: a) RP-L ComfortGel Cush and Flap model number 1031404 and b) RP-M ComfortGel Cush and Flap model number 1031403. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall
Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

Non-continuous ventilator accessories under the following brand names: a) RP-P ComfortGel Cush and Flap model number 1031391 and b) RP-S ComfortGel Cush and Flap model number 1031392. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall
Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

Non-continuous ventilator accessories under the following brand names: a) RP-BIPAP Flow Pick-Up Tube Kit model number 332185; b) RP-BIPAP M Series Keypad model number 1038122; and c) RP-BIPAP Pro 2 /Plus Tubing Kit model number 1020358. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall
Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

Non-continuous ventilator accessories under the following brand names: a) RP-ComfortGel Gel Cushion M model number 1009050; b) RP-ComfortGel Gel Cushion P model number 1009048; c) RP-ComfortGel Gel Cushion S model number 1009049; d) RP-ComfortGel Silicone Flap L model number 1009109; e) RP-ComfortGel Silicone Flap M model number 1009054; and f) RP-ComfortGel Silicone Flap S model number 1009053. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall
Terminated ·Respironics, Inc.·Product code BZD·October 15, 2007

Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk model number F35465; b) RP-Seal, Greece, Ballscrew model number F35036; c) RP-Tub PVC 1/8 in x 50 ft model number 1008841; d) RP-Vision Filter Cover model number 1003444; e) RP-Vision RS-232 HRN ABV 106K model number 1004699; and f) RP-Wrap, Cord model number F35195. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

FDA Recall
Terminated ·Respironics, Inc.·Product code CBK·October 15, 2007

The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

FDA Recall
Terminated ·Baxter Healthcare Corporation·Product code KDI·January 7, 2021

Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

FDA Recall
Terminated ·Baxter Healthcare Corporation·Product code KDI·January 28, 2021

Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

FDA Recall
Terminated ·Baxter Healthcare Corporation·Product code KDI·January 28, 2021

Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

FDA Recall
Terminated ·Baxter Healthcare Corporation·Product code KDI·January 28, 2021

Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).

FDA Recall
Terminated ·Baxter Healthcare Corporation·Product code KDI·January 28, 2021

0.9% Sodium Chloride Injection, USP, Flush Syringe, 10 mL in 12 mL, Sterile, Rx only, Code No. 2T0806 Usage: Flush syringe.

FDA Recall
Terminated ·MRP, LLC dba AMUSA·Product code NGT·April 27, 2015

0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.

FDA Recall
Terminated ·MRP, LLC dba AMUSA·Product code NGT·July 2, 2015

LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223

FDA Recall
Terminated ·GMP Companies/Lifesync Corporation·Product code DRG·January 10, 2007

T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.

FDA Recall
Terminated ·MRP, LLC dba AMUSA·Product code NGT·February 9, 2015

Syneture Ti-Cron 0 BLUE 6X18" PRE-CUT non-absorbable polyester sutures Material 8886300162 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures

FDA Recall
Terminated ·Product code GAP·June 3, 2011