6 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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Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.
FDA Enforcement
Class II
·Terminated·Bioseal Corporation·August 19, 2020
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·August 15, 2012
FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM (1) TOWEL 3PL Y POLY 17" X 18" (2) SWABSTICK DRY COTTON (1) DRAPE 4" FENESTRATED 18" X 26" (1) CATHETER FOLEY 18FR, 2WAY SILICONE COATED m SYRINGE 10ccWATERPREFIL UF (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF (1)SPECIMEN CONTAINER 4oz W/LID & LABEL 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
PLASTIC SURGERY PACK- (1) MAYO STAND COVER REINFORCED LIF (1) CAUTERY TIP POLISHER LIF (1) BAG SUTURE FLORAL L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (20) GAUZE SPONGES 4" X 4" 4PL Y (1) COVER TABLE REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) PENCIL CAUTERY HANDSWITCHING L/F (1) TUBE SUCTION CONNECT. ~, X 12' LIF (1 0) LAP SPONGE PRE-WASH XRD LIF (2) LITE GLOVE LIF (4) HUCK CLOTH TOWEL BLUE (2) DRAPE SHEET MEDIUM 41" X 69" LIF (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF (1) DRAPE LAP ABDOMINAL WITH POUCH STD SMS (5) Pk. STERI STRIP CLOSURE %"X 4" L/F (1) MAGNETIC INST. DRAPE (3) SKIN MARKER WITH RULER LIF (1) EXTENDED ELECTRODE BLADE (2) ABSORBENT TOWEL 15" X 20" LIF (4) UTILITY BOWL 32 oz (2) SURGEON GLOVES #8 BIOGEL 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
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
LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE ULTRA VERES 120MM LIF ( 1) TROCAR ENDOPATH XCEL DILATING TIP (K11LT) LIF ( 1) TROCAR ENDO.XCEL DILATING TIP (KSLT) LIF (1) GOWN IMPERV. XTRA REINFORCED XL T/WRAP AAMI III (1) MAYO STAND COVER REINFORCED LIF (5) SPONGE LAP PREWASH 18" X 18" XRD LIF ( 1) CONTAINER SPECIMEN 40Z. WITH LID & LABEL LIF ( 1) BOWL UTILITY 16oz. LIF (1) SOLUTION SURGICAL DURAPREP 26ML ST. LIF (1) DRAPE LASER CAMERA W/EL 6" X 96" LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (1) DRAPE ENDOSCOPY 100" X 123%" X 77" WITH TROUGHS L/F (2) SHEET DRAPE 42" X 57" SMS LIF (1) BLADE SURGICAL #11 STAINLESS STEEL ( 1) TIME OUT BEACON NON WOVEN ST L/F (6) GAUZE SPONGE 2" X 2" 4PL Y LIF ( 1) BLADE SURG. #15 CARBON STEEL ( 1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" L/F 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