14 results
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13ms
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Sources: EU EUDAMED, US FDA
FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/RT L SML+ FEM PRC RT M/LT L SML+ FEM PRC LT M/RT L REG FEM PRC RT M/LT L REG FEM PRC LT M/RT L REG+ FEM PRC RT M/LT L REG+ FEM PRC LT M/RT L LGE FEM PRC RT M/LT L LGE FEM PRC LT M/RT L LGE+ FEM PRC RT M/LT L LGE+ " These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018
LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED L/F (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF (1) SURGICAL BLADE #11 CARBON STEEL (1) TUR Y SET, 2LEAD L/F (4) DRAPE UTILITY WITH TAPE LIF (1) TROCAR ENDO. XCEL DILATING TIP 5mm (K5LT) (1) ULTRA VERES NEEDLE 120mm (1) NEEDLE & BLADE COUNTER 20C FOAM/MAG LIF (1) DRAPE LAP. ABDOM. WITH POUCH 102" X 122" X 78" (2) DRAPE SHEET 41" X 58" SMS (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (10) GAUZE SPONGE 4" X 4" 16PLY XRD L/F (5) LAP SPONGE PREWASH XRD LIF (1 ) DRAPE LASER CAMERA W/EL. 6" X 96" LIF (1) TUBE SUCTION CONNECT. 3/16" X 12' LIF (1) TROCAR ENDOPATH XCEL DILATING TIP 11mm (K1 1LT) (1) TUBING INSUFLATION SET W/0 RING ADAPTOR LIF (1) SURGICAL DURAPREP SOLUTION 26ML LIF (1) TABLE COVER REINFORCED 50" X 90" LIF 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
Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
FDA Enforcement
Class II
·Terminated·MWT Materials, Inc.·January 27, 2016
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·March 21, 2018