28 results
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56ms
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Sources: EU EUDAMED, US FDA
ECG SENSOR TYPE II
FDA Adverse Event
Other
·NIKO MEDICAL PRODUCTS·Product code DRX·April 19, 2000
L3C1950 - UNO OR/SECUREMENT
FDA Adverse Event
Malfunction
·UNOMEDICAL S.R.O.·Product code KGX·October 11, 2021
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·November 5, 2020
NIKA Medical Produkte GmbH
Manufacturer
🇩🇪 Germany
NIKA Medical Produkte GmbH
Importer
🇩🇪 Germany
DISOPA SOLUTION
FDA Adverse Event
Injury
·ADVANCED STERILIZATION PRODUCTS·Product code MED·August 21, 2019
Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall, Multirall and Masterlift Systems Product Usage - The Overhead Rail System allows overhead lifts to be mounted to the ceiling allowing versatility for use in lifting situations. It can be used with different Liko ceiling lifts.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FSA·October 31, 2012
13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
FDA Recall
Terminated
·Nico Corp.·Product code GZT·July 17, 2012
13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
FDA Recall
Terminated
·Nico Corp.·Product code GZT·July 17, 2012
Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko a Hill-Rom Company. Enables a comfortable sitting position and adapts to the patient without the need for individual adjustments when transferring a patient with a lift.
FDA Recall
Terminated
·Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006·Product code FSA·February 9, 2011
Liko Mobile Lifts: Primarily intended for use in nursing homes Liko M220, Model 2050010
FDA Recall
Open, Classified
·Hill-Rom, Inc.·Product code FSA·December 23, 2021
Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FSA·February 21, 2022
Liko Mobile Lifts: Primarily intended for use in nursing homes LikoM230 Model: 2050015
FDA Recall
Open, Classified
·Hill-Rom, Inc.·Product code FSA·December 23, 2021
Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FSA·December 6, 2012
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document.
FDA Recall
Terminated
·Synaptive Medical Inc·Product code HAW·October 9, 2018
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010 17x31.5 MHP DECQ; NN-8015 NICO Fluid System (NFS); NN-8017 11x13 MHP/PB; NN-8018 13X13 MHP/PB; NN-8019 19x28 MHP Little LOTTA; NN-8020 19x21.5 MHP PaediScope; NN-8021 15x26.5 MHP LOTTA; NN-8500 15x10 MHP; NN-8501 15x13 MHP; NN-8502 15x25 MINOP MHP; NN-8503 13x10 MHP; NN-8504 13x13 MHP; NN-8505 15x25 GAAB MHP; NN-8506 11X10 MHP; NN-8507 11x13 MHP; NN-8508 19x28 OI MHP; NN-8510 17x31.5 DECQ MHP; NN-8517 13X13 MHP/PB; NN-8518 11x13 MHP/PB; NN-8519 19x28 Little LOTTA MHP; NN-8520 19x21.5 PaediScope MHP; NN-8521 15X26.5 LOTTA MHP;
FDA Recall
Open, Classified
·Stryker Corporation·Product code GEI·October 31, 2025
NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber
FDA Recall
Open, Classified
·Stryker Corporation·Product code GEI·October 31, 2025
Liko Universal SlingBars Universal SlingBar" 350, Universal SlingBar" 350 QRH, Universal SlingBar" 350 R2R, Universal SlingBar" 450, Universal SlingBar" 450 QRH, Universal SlingBar" 450 R2R, Universal SlingBar" 600 Universal SlingBar" 600 QRH Component of Liko Lifts Product Usage: Universal SlingBar 350 It is commonly used for lifting children. Universal SlingBar 350 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 450 Is appropriate in most cases and with most slings. Is installed on most lifts on delivery (does not apply to Viking XL). Universal SlingBar 450 is available with three assembly options - fixed assembly, Quick-release Hook (QRH) or Room 2 Room (R2R). Universal SlingBar 600 It is intended for use with the ComfortSling Plus mod 300/310 and 350/360, or with slings the intention of which is to overlap the leg supports, Universal SlingBar 600 is available with two assembly options - fixed assembly and Quick-release Hook (QRH).
FDA Recall
Terminated
·Hill-Rom, Inc.·Product code FSA·March 8, 2016
NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK;
FDA Recall
Open, Classified
·Stryker Corporation·Product code GEI·October 31, 2025
CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve Model:FN-803FGA. Private labeled for Femcare-Nikomed in the UK. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code KZD·September 20, 2008