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    ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00271081·

    AMD-RITMED

    FDA UDI
    AMD Medicom Inc·10686864055973·AMD-RITMED BOUFFANT CAP 21 Inch

    Diamond Orthopedic, LLC

    FDA UDI
    DIAMOND ORTHOPEDIC, LLC·B551DMD2002718·3.0mm, Cannulated Screw, Self Drilling, Long T...

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF20027180·3.0mm Cannulated Screw, Self-Drilling, Long Thr...

    CHROMOSTREAK

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MILLENNIA ACUPUNCTURE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NA

    FDA UDI
    GE Healthcare Finland Oy·00840682102865·PEDI-LITE+ SPIROMETRY KIT 2M/7FT, 8002718

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 13, 2013

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 28, 2011

    INTRAOCULAR LENS

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL·Product code HQL·February 26, 2008

    IMPL SWISSPLUS OCTAGON 4. 1MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 14, 2022

    Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDING CAST SOFT ROLL 6 X 4yds. (1) GOBAN SELF-ADHERENT WRAP 6 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (10) GAUZE SPONGES 4 X 4 16PLY XRD (3) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 (1) NEEDLE HYPODERMIC 22G X 1 (1) SYRINGE 30cc W/0 NEEDLE LUER LOCK (1) SCALPEL W/HANDLE 11 (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (1) RULER (3) Pr. GLOVESURG 8 DERMA PRENE POWDER FREE (1) BANDAGE ELASTIC KNIT STD 10yds (1) BANDAGE ESMARK 6 X 9yds (8) TOWELS CLOTH HUCK BLUE (1) U - DRAPE 60 X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) BOWL UTILITY 16oz. (1) COVER TABLE REINFORCED 50 X 90 (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL REINFORCED X-LARGE T/WRAP (2) TOWELS ABSORBENT 15X 20 (1) STOCKINETTE IMPERV 12 X 48 (2) BAG PLASTIC 6 X 12 (1) KNEE ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (2) LITE GLOVE 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

    Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDING CAST SOFT ROLL 6 X 4yds. (1) GOBAN SELF-ADHERENT WRAP 6 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (10) GAUZE SPONGES 4 X 4 16PLY XRD (3) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 (1) NEEDLE HYPODERMIC 22G X 1 (1) SYRINGE 30cc W/0 NEEDLE LUER LOCK (1) SCALPEL W/HANDLE 11 (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (1) RULER (3) Pr. GLOVESURG 8 DERMA PRENE POWDER FREE (1) BANDAGE ELASTIC KNIT STD 10yds (1) BANDAGE ESMARK 6 X 9yds (8) TOWELS CLOTH HUCK BLUE (1) U - DRAPE 60 X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) BOWL UTILITY 16oz. (1) COVER TABLE REINFORCED 50 X 90 (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL REINFORCED X-LARGE T/WRAP (2) TOWELS ABSORBENT 15X 20 (1) STOCKINETTE IMPERV 12 X 48 (2) BAG PLASTIC 6 X 12 (1) KNEE ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

    Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·May 4, 2016

    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018