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Sources: EU EUDAMED, US FDA
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Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005. b. SKIN MARKER MAMMO BB2.0 100B - Mammography Skin Marker Catalog # SDM-BB20.
FDA Enforcement
Class III
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022
RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizontal Centrifuge, Model M510, Product No. SSH4. The RTH8 rotor is used with the Statspin Express 4 Horizontal Centrifuge. StatSpin Express 4 Centrifuge: For in vitro diagnostic use to produce the rapid separation of whole blood contained in original collection tubes.
FDA Enforcement
Class II
·Terminated·Iris Diagnostics·December 31, 2014
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
FDA Enforcement
Class II
·Terminated·Iris Diagnostics·May 22, 2013
IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
FDA Enforcement
Class III
·Terminated·Iris Diagnostics·August 8, 2012
iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.
FDA Enforcement
Class II
·Terminated·Iris Diagnostics·September 2, 2015
REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL (2) SCALPEL WEIGHTED SAFETY # I0 (I) STOCKrNETTE IMPERV 14" X 48" (I) TIME OUT BEACON NON WOVEN (2) DRAPE U 60" X 70"WI TAPE SPLIT 6" X 21 " (2) TUBE SUCTION CONNECT'/.'' X 12' (2) DRAPE INCISE ANTIMICROBIAL 23" X 17" (2) LIGHT SHIELD (I) NEEDLE SPINAL ANESTH 18G X 3 Y, (4) STR IPS TAPE 24" X 4" (I ) GOWN IMP. XTRA REINF SMS XL T/W LEVEL (20)GAUZE SPONGES 4" X 4" 16PLY (3) DRAPE '!. ECONOMY 53" X 77" (I) DRAPE UNDERBUTTOCK W/POUCI-1 44" X 35" (I) DRAPE TOP WIADHESIVE 108" X 50" STD SMS (I) COUNTER NEEDLE 60C FOAM STRIP/MAG STRIP (I) YANKAUER OPEN TIP CLEAR W/0 CIV (2) DRAPE SIDE 36" X 77" W/ADl-1. (I) SHEET SPLIT W/ADHES 108" X 77" STD SMS (I) SYRINGE 60ML UL W/0 NEEDLE (I) POLISHER CAUTERY TIP (I) NEEDLE BLUNT FILL 1 8G X I Y, (2) COVER TABLE BTC 77" X I I 0"l-ID FULL COVERAGE (2) GLOVE SURG. DERMA PRENE #8 POWDER FREE (10) SPONGE LAP PREWASH 18" X 18" XRD (I) COVER MAYO STAND W/CSR 23" X 54" (I) BOWL UTILITY QUART 32oz. (3) CLAMP TOWEL (I) BOWL UTILITY PINT 16oz. (3) GOWN MICROCOOL IMP. XTRA LONG XL (3) BANDAGE ELASTIC 6" X 5YRD WIVELCRO (I) MERLING SKrN PREP APPLIC.39ML (2) PADDING CAST SOFT ROLL 6 X 4YRD (I) MAYO TRAY LARGE 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
11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
FDA Enforcement
Class II
·Terminated·Ii - Vi Incorporated·June 13, 2018
Heraeus, PALAMIX duo. Material Number: 66057897.
FDA Enforcement
Class III
·Ongoing·Heraeus Medical GmbH (Dental Division)·May 6, 2026
Heraeus, PALAMIX uno. Material Number: 66057893.
FDA Enforcement
Class III
·Ongoing·Heraeus Medical GmbH (Dental Division)·May 6, 2026
Philips OMNI II TEE Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Philips OMNI III TEE Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips X7-2 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Philips S4-1 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X
FDA Enforcement
Class III
·Ongoing·Penner Patient Care, Inc.·March 18, 2026
Philips C9-4 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips L17-5 Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026
Philips Mini Multi TEE Ultrasound Transducer
FDA Enforcement
Class III
·Ongoing·Philips Ultrasound, Inc·April 1, 2026