60 results
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13ms
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Sources: EU EUDAMED, US FDA
MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses.
FDA Enforcement
Class II
·Terminated·Southern Implants, Inc·March 18, 2015
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
FDA Enforcement
Class II
·Terminated·NOX MEDICAL·October 13, 2021
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·September 19, 2012
E..N.T. PACK - (5) SPONGE TONSIL 7/8 XRD (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED L/F (1) TUBE SUCTION CONNECT %" X 12' L/F (1) CAUTERY TIP POLISHER LIF (1) SUTURE BAG FLORAL (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) CAUTERY PENCIL HAND SWITCHING (2) ABSORBENT TOWELS 15" X 20" L/F (1) DRAPE SHEET 41 " X 58" SMS L/F (1) EAR/ULCER SYRINGE 2oz LIF (2) MEDICINE CUP 2oz (1 0) GAUZE SPONGE 4" X 4" 16PL Y (1) *Pr. SURGICAL GLOVES #7% POWDER (1) *Pr. SURGICAL GLOVES #7 POWDER (9) LABEL FOR SKIN MARKER 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
Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.
FDA Enforcement
Class II
·Terminated·Amerx Health Care Corp.·July 27, 2016
Amerigel Wound Dressing 1 oz. tube
FDA Enforcement
Class II
·Terminated·Kova Laboratories, Inc.·July 16, 2014
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·September 19, 2012
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·September 19, 2012
CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Enforcement
Class I
·Terminated·Custom Medical Specialties, Inc.·September 26, 2012
CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Enforcement
Class I
·Terminated·Custom Medical Specialties, Inc.·September 26, 2012
CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Enforcement
Class I
·Terminated·Custom Medical Specialties, Inc.·September 26, 2012
Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.
FDA Enforcement
Class II
·Terminated·Medline Industries Inc·August 17, 2016
BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Enforcement
Class I
·Terminated·Custom Medical Specialties, Inc.·September 26, 2012
CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep
FDA Enforcement
Class I
·Terminated·Custom Medical Specialties, Inc.·September 26, 2012
USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators). These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***[email protected] www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***USA-002 Rev A***" Printed marketing brochure
FDA Enforcement
Class II
·Terminated·Non-Invasive Monitoring Systems, Inc.·June 27, 2012
US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***[email protected] www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***US-001 Rev A***" Printed marketing brochure
FDA Enforcement
Class II
·Terminated·Non-Invasive Monitoring Systems, Inc.·June 27, 2012
NEURO SPINE PACK CONTENTS: (1) SUTURE BAG FLORAL LIF (1) NEEDLE & BLADE COUNTER SOC FOAM STR//MAG STR (2) COVER TABLE BTC 77" x 110" HD FULL COVERAGE LIF (4) DRAPE UTILITY WITH TAPE LIF (1) SHEET 'I" 60" X 77" DRAPE REINF. LIF (2) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) CUP MEDICINE 2oz UF (2) TUBE SUCTION CONNECT v.'' X 12' UF (2) SKIN MARKER INK WITH 8 LABEL (20) GAUZE SPONGE 4" X 4" 16ply XRD UF (5) SPONGE LAP PREWASH 18"X 18" XRD UF (2) SYRINGE 20cc W/0 NDL LILOCK ST.LIF (1) YANKAUER SUCT. TUBE W/0 VENT LIF (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" LIF (1) POLISHER CAUTERY TIP LIF (2) PENCIL CAUTERY HAND SWITCHING LIF (1) DRAPE T LAPAROTOMY 102" X 78" X 121" STD SMS LIF (1) GOWN SURG REINFORCED LARGE TOWEL WRAP (2) BLADE SURG #15 CARBON STEEL (1) PK.STRIP SURGICAL %" X 6" COTTON (1) PK.STRIP SURGICAL Y4" X 6" COTTON (10) GAUZE SPONGE 4" X 4" 16ply (1) NEEDLE HYPODERMIC 20G X 1 % (1) BASIN WASH ROUND 6qt (4) SHEET DRAPE 42" X 57" SMS LIF (2) DERMABOND HV TOPICAL SKIN ADH (1) BOWL UTILITY 32oz. (2) SYRINGE EAR/ULCER 2oz LIF (2) BLADE EXTENDED ELECTRODE (2) SOLUTION SURGICAL DURAPREP 26mL UF (1) ELECTRODE NEEDLE 1in W/TIP PROTECTOR (1) STRIP SURGICAL 'I"X 6" (2) GOWN XL SMS IMPERV. REINFORCED UF (1) CORD BIPOLAR FIRCEPS (4) TOWEL CLOTH HUCK (WHITE) (2) DRESSING OPSITE POST PO 2%" x 2" (2) POUCH INSTRUMENT 7 X 11 (1) MAYO TRAY LARGE (1) MAYO STAND COVER REINFORCED 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
CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP APPLICATOR (4) PVP PREP SOLUTION 1 oz (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) EXAM GLOVES MEDIUM (1) WRAPPER 24" X 24" UF (1) PACKING TRAY 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
08 PAD PACK II (2,3) CUSTOMED CONTENTS: (3) TOWEL ABSORBENT 15" X 20" (1) BOWL W/LID PLASTIC 80oz (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) SHEET PLASTIC 44" X 65" (1) DRAPE UNDERBUTTOCK W/POUCH (1) UMBILICAL CORD CLAMP (1) BABY BLANKET 30" X 30" POLY ABSOR.IMP. (1) PACKING VAGINAL XRD 4" X 36" 8PLY (10) GAUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE ABDOMINAL WITAPE 40" X 54" (2) LEGGINS W/7'' CUFF 30" X 42" (1) TABLE COVER REINFORCED 44" X 78" (2) PAD OBSTETRICAL XL (1) EAR ULCER SYRINGE 2oz. 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
C - BIRTH PACK II {2) CUSTOMED CONTENT: (1) GOWN SURGEON REINFORCED XLGE TOWEL/WRAP LIF (4) TOWEL ABSORBENT 15" X 20" LIF (2) GOWN XLGE SMS IMPERVIOUS REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BLANKET BABY 30" X 30" POLYABS IMPERVIOUS LIF (1) SYRINGE EAR/ULCER 2oz LIF (2) PAD OBSTETRICAL X-LARGE (1) BOWL WITH/LID PLASTICS 80oz LIF (1) CLAMP UMBILICAL CORD LIF (1) BAG SUTURE FLORAL LIF (1) DRAPE C-SECTION W/POUCH 102" X 121" X 78" LIF (1) COVER TABLE 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