781 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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LAPAROSCOPY PACK - (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF (1) DRAPE ENDOSCOPY 1 00" X 123W' X 77" WITH TROUGHS (1) MAYO STAND COVER REINFORCED LIF (4) TOWEL ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (5) GAUZE SPONGE 2" X 2" 4PL Y (1) CORD LAPAROSCOPY FOOD SWICHING MONOPOLAR (1) SCALPEL WEIGHTED SAFETY #11 (1) SOLUTION SURGICAL DURAPREP 26ml UF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LITE GLOVE UF (1) SUTURE BAG FLORAL UF (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (1) UTILITY BOWL 32oz. (2) SHEET DRAPE 42" X 57" SMS (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (5) TAPE TEGADERM 2 3/8 X 2 o/. UF (5) LAP SPONGE PREWASH 18" X 18" XRD L/F (2) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE (1) GOWN SURG SMS POLY-REINF BREATHABLE IMPERVIOUS SLEEVE AAMI LEVEL IV CRITICAL ZONE X-LARGE TOWEL/WRAP 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
UNIVERSAL PACK - (1) TRAY ORGANIZER FULL DEEP (1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE HYPODERMIC 20G X 1 ~ UF (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS AAMI Ill (1) SHEET SPLIT WITH ADHESIVE 108" X 77" STD SMS LIF (1) SHEET% 57" X 63" REINFORCED SMS LIF (2) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY LIF (1 0) GAUZE SPONGES 4" X 4" 12PL Y LIF (4) CLOTH HUCK TOWELS BLUE LIF (1) TABLE COVER REINFORCED 50" X 90" UF (1) SCALPEL WITH HANDLE #11 (1) DENTURE CUP WITH LID (1) TRAY 2 COMPARTMENT (2) ABSORBENT TIP APPLICATOR (1) IMPERVIOUS STOCKINETIE 14" X 48" LIF (1) TAPE TRANSPORE 1" X 36" (1) DIISP NEEDLE 30 X ~ (1) PROBE DRAPE 6" X 96 WITH GEL (1) ARTERIAL NEEDLE 18 X 2 % (1) CATHETER INTRODUCER 7FR (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR 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
LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" UF (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (8) TOWELS CLOTH HUCK BLUE UF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) STRIP STERI DRAPE LARGE 17" X 23" UF (1) SCALPEL WITH HANDLE #11 (1) COVER FLUORO 30" X 30" WITH RUBBER BAND UF (1) DRAPE CHEST 100" X 142" X 72" (1) RULER FLEXIBLE PLASTIC (1) SOLUTION SURGICAL DURAPREP 26ML UF (1) SHEET :X 60" X 77" DRAPE REINFORCED UF (1) STRIP STERI CLOSURE%'' X 4" UF (2) GOWN SOFT SMS STD. XL SET IN SLEEVE UF (4) NEEDLE HYPODERMIC 18G X 1 % U (1) SKIN MARKER W/RULER UF (1) NEEDLE HYPODERMIC 25 X 1 % UF (1) DRESSING TELFA 8" X 3" NON ADH UF (1) DRESSING TEGADERM 4 X 4%" UF (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VIALL /F (1) BAG ZIP LOCK UF (9) LABELS FOR SKIN MARKERS UF 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
One Step K in vitro diagnostic test REF: 81A4
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step 10A in vitro diagnostic test
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step UTI in vitro diagnostic test REF: 3374
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
Uric Acid in vitro diagnostic test REF: 31H0P
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step pH in vitro diagnostic test REF: 31I4P
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
CLARITY II Laser System; Model No. 1110200210.
FDA Enforcement
Class II
·Ongoing·Lutronic Corporation·March 18, 2026
Genesis Push-In Suture Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Fixone Biocomposite Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Genesis Knotless Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Genesis Dual Thread Screw-In Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Genesis Screw-In Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
AlternatiV+ Max Knotless Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
AlternatiV+ Screw-In Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Fixone Hybrid Anchor
FDA Enforcement
Class II
·Ongoing·Aju Pharm Co., Ltd.·February 4, 2026
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
FDA Enforcement
Class II
·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
FDA Enforcement
Class II
·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025
XERF EFFECTOR 60. Electrosurgical unit.
FDA Enforcement
Class II
·Ongoing·Lutronic Corporation·October 22, 2025