65 results
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17ms
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Sources: EU EUDAMED, US FDA
HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.
FDA Recall
Terminated
·Haag-Streit USA Inc·Product code EPT·July 31, 2019
HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.
FDA Recall
Terminated
·Haag-Streit USA Inc·Product code EPT·July 31, 2019
HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage: A wide range of surgical interventions are made possible through the modular construction and the diversity of the equipment and accessories. The operating microscope HS Hi-R NEO 900/HS Hi-R NEO 900A/HS Hi-R NEO 900A NIR and HS ALLEGRA 900/590/90 are designed for use in Ophthalmology and in other disciplines where a vertical line of viewing is required. Due to their high maneuverability, the HS ALLEGRA range of operating microscopes are qualified for further applications, in particular ENT- and reconstructive microsurgery are possible, because their line of sight can be tilted or adjusted horizontally. The HS ALLEGRA 590 is particular because of its multidisciplinary application possibilities.
FDA Recall
Terminated
·Haag-Streit USA Inc·Product code EPT·July 31, 2019
Maximum Pelvic Trainer (MPT)
FDA Recall
Terminated
·Ralston Group·Product code HIR·July 12, 2019
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
FDA Recall
Terminated
·Apheresis Technologies, Inc.·Product code FIR·July 9, 2012
Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic plasma exchange.
FDA Recall
Terminated
·Apheresis Technologies, Inc.·Product code FIR·April 1, 2009
American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic
FDA Recall
Terminated
·American Diagnostica, Inc.·Product code GIR·February 28, 2007
PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma exchange.
FDA Recall
Terminated
·Apheresis Technologies, Inc.·Product code FIR·November 29, 2010
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Recall
Terminated
·STEP-HAR MEDICAL LLC·Product code FRN·February 26, 2021
JK Bariatric Beds, True Air Technologies, Inc.
FDA Recall
Terminated
·SCM True Air Technologies LLC·Product code OSI·March 18, 2014
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
FDA Recall
Terminated
·SCM True Air Technologies LLC·Product code OSI·March 18, 2014
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
FDA Recall
Terminated
·SCM True Air Technologies LLC·Product code FNM·March 18, 2014
ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
FDA Recall
Terminated
·Extended Care Air Therapy Systems Inc·Product code FNL·April 5, 2006
Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (US) N REFURBISHED, Part Number CS78651
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (INTL) M, CS08654
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018
CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV
FDA Recall
Terminated
·Oridion Medical 1987 Ltd. Har Hotzvim Industrial·Product code DQA·July 31, 2018