30 results
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12ms
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Sources: EU EUDAMED, US FDA
Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.
FDA Enforcement
Class II
·Terminated·SANTA JOY ORNAMENT & GIFTWARE CO·June 13, 2018
DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.
FDA Enforcement
Class II
·Terminated·Euro Diagnostica AB·March 14, 2018
Savaria SL-1000 Stairlift
FDA Enforcement
Class II
·Terminated·Savaria Concord Lifts, Inc.·May 17, 2017
TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016
TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016
RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016
TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016
TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,
FDA Enforcement
Class II
·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016
Omega Incline Platform Lift
FDA Enforcement
Class II
·Terminated·Savaria Concord Lifts, Inc.·May 3, 2017
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
FDA Enforcement
Class II
·Terminated·Perkin Elmer Health Sciences, Inc.·October 30, 2013
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.
FDA Enforcement
Class III
·Terminated·Euro Diagnostica AB·July 5, 2017
Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4.
FDA Enforcement
Class II
·Terminated·Phadia Ab·April 11, 2018
TOTAL HYCTERECTOMY (I) CANNULA 5MM XCEL SLEEVES LIF ( I ) TROCAR XCEL BLADELESS II MM (I) TROCAR 5MM BLADELESS W/STAB SLEEVE LIF ( I) NEEDLE ULTRA VERES 120MM LIF ( I) TUBING INSUFFLAT SET W/0 R ING ADAPTOR LIF (I) DRAPE VIDEO CAMERA 13cm X 244 em LIF ( I ) DRAPE LAP ABDOM W/POUCH 1 02" X 1 22" X 78" STD SMS (2) LEGGINGS W/7" CUFF 30'' X 42" ( I ) SAFETY SCALP EL # II S/STEEL ( I ) GOWN IMPERV. XTRA REINF. XL T/WRAP LEVEL III ( I ) TABLE COY ER REINFORCED 50" X 90" LIF (4) DRAPE UTILITY WIT APE LIF (2) DRAPE SI-IEET 42" X 57" SMS (I) TUBE SUCTION CONNECT Y." X 1 2' LIF ( I ) MAYO STAND COYER REINFORCED LIF (1 0) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (4) TOWELS ABSORBENT 1 5" X 20" LIF (2) LITE GLOVE ( I ) DRAPE UNDERBUTTOCK W/ PO UCl-144" X 35" (2) SYRINGE I Occ W/0 NEEDLE LILOCK LIF (2) SPEC IMEN CONTA INER 4oz W/LID & LABEL (1 5) LAP SPONGE PREWASH 18'' X 1 8" XRD LIF ( I ) PVP PAINT 8" STICK SPONGE ( I ) UTILITY BOWL QUART 32oz LIF ( I ) ELECTRODE DUAL DEPRES ( I) DRESSING OPSITE POST PO 2!12 X 2" ( I ) MERLINO SK IN PREP APPLIC. 39ML LIF (3) GOWM XL SMS IMPERVIOUS REINFORCED LIF ( I ) CORD LAPAROSCOPY MONOPOLAR FOOD SWICH ING (1) FOLEY CATHETER KIT CONTAINING: (I) CATHETER 1 6FR FOLEY 2WAY, Sec (I) PYP TR IPLE SWABSTICK IODOPHOR (2) SWABSTICK DRY COTTON ( I ) SYR I NGE IOcc WATERFREFIL LIF (2) GLOVE MED FREETOUCH YYN I L P/F (I) TOWEL3PLYPOLY 17" X 18" (I) DRAPE 4" FENESTRATED 18" X 26" (I) LABEL lD PATIENT (I) JELLY LUBRI CATING FIVE GRAM ( I ) URINARY BAG DRAINAGE 2000ML ANTI-REFLUX LIF ( I ) TRAY SBS ( I ) WRAPPER 24" X 24" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.
FDA Enforcement
Class II
·Terminated·INNOKAS MEDICAL OY·August 31, 2016
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
FDA Enforcement
Class II
·Terminated·INNOKAS MEDICAL OY·February 4, 2015
CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
FDA Enforcement
Class II
·Terminated·Innokas Medical Oy·November 18, 2015
Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
FDA Enforcement
Class II
·Terminated·Palodex Group Oy·January 29, 2020