57 results
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7ms
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Sources: EU EUDAMED, US FDA
CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK (1) MAYO STAND COVER REINF. LIF (1) EYE DRAPE LIF (1) SYRINGE 3cc W/0 NDL L/LOCK LIF (1) WIPE INSTRUMENT 1MM L/F 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
Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 6, 2024
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082070
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082060
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082065
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARACT PACK, REF DYNJ54869F; d) CATARACT PREP PACK, REF DYNJ44917L; e) E-BLEPH CDS, REF CDS983585G; f) EYE CDS, REF CDS983916G; g) EYE KIT, REF DYKM2222; h) EYE PLASTIC PACK, REF DYNJ47859C; i) K PACK, REF LYN030KAGVD; j) OCULOPLASTY PACK, REF DYNJ64572A; k) OL OCULAR, REF DYNJ906183J; l) OL OCULAR, REF DYNJ906183K; m) P M CATARACT, REF DYNJ44917G; n) P M CATARACT, REF DYNJ44917I; o) P PACK, REF LYN030POGVD; p) R VITRECTOMY, REF EYP087W; q) VITRECTOMY PACK, REF DYNJ68884B
FDA Enforcement
Class I
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·March 6, 2024
PHACO PACK - (10) GAUZE SPONGE 4" X 4" 12PLY (2) SYRINGE 3cc W/NDL. 21G X 1 %" (2) MEDICINE CUP 2 oz. (1) OPHTHALMIC DRAPE W/POUCH (1) GOWN STANDARD LGE.SMS (1) GOWN NON REINF. Lge. T/Wrap SMS (1) EYE SHIELD UNIVERSAL (1) TABLE COVER 44" X 90" (1) MAYO STAND COVER REINF. LIF (3) ABSORBENT TOWEL 15" x 20 LIF (2) EYE PAD 2 1/8 X 2 5/8 LIF (1 0) EYE SPEAR MICRO SPONGE VELCRO/NECK 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
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780070
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781035
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780060
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780075
FDA Enforcement
Class I
·Ongoing·TELEFLEX LLC·July 5, 2023