40 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
FDA Enforcement
Class I
·Terminated·Cook Inc.·August 12, 2015
Tummy Tuck Pack, code 900-2684, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6 (6) TOWEL CLOTH HUCK (BLUE) (10) LAP SPONGE PREWASH 18 X 18 XRD ( 1) CAUTERY TIP POLISHER ( 1) DRAPE BREAST/CHEST SMS 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
Breast Augmentation Pack, Imagenes Cosmetic, code 900-2682: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) TUBE SUCTION CONNECT ( 1) MAYO STAND COVER REINFORCED ( 1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 ( 1) RULER 6 CLEAR (6) TOWEL CLOTH HUCK (BLUE) (10) LAP SPONGE PREWASH 18 X 18 XRD ( 1) CAUTERY TIP POLISHER ( 1) YANKAUER SUCTION TUBE W/O VENT ( 1) DRAPE BREAST/CHEST SMS 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
Liposuction Pack, code 900-2681, contains: (3) GOWN SOFT SMS STD XLGE SET IN SLEEVE (1) TUBE SUCTION CONNECT (1) MAYO STAND COVER REINFORCED (1) SKIN MARKER INK W LABEL (2) TABLE COVER REINFORCED 50 X 90 (1) RULER 6 CLEAR (12) TOWELS CLOTH HUCK (BLUE) (1 0) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY TIP POLISHER (20) GAUZE SPONGE 4X 4 12PL Y (4) TOWEL CLAMP (1) Y CONNECTOR (1) CAUTERY PENCIL PUSH BOTTOM (3) DRAPE SHEET 98 X 63 STD SMS 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
CYSTO TUR PACK BASIC CODE 900-2899. CONTENTS: (2) LEGGINGS W/7'' CUFF 30" X 42" (1) COVER TABLE REINFORCED 44" X 78" (2) TOWELS ABSORBENT 15" X 20" (1) GOWN XLGE SMS IMPERV. REINFORCED AAMI LEVEL Ill (1) TUR CYSTO IRRIGATION SET 79" SINGLE (1) TIME OUT BEACON NON WOVEN ST (1) BAG SUTURE FLORAL (1) UTILITY BOWL 32oz (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) TURP CYSTO DRAPE WITH POUCH (1) GOWN IMPER EXTRA REINF LGE AAMI LEVEL Ill TOWEL & WRAP 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
LAPAROTOMY PACK BASIC CODE 900-2829 CONTENTS: (2) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROT 102" X 78" X 121" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill (1) TIME OUT BEACON NON WOVEN (1) COUNTER NDUBLADE 20C FOAM/MAG (1) SKIN MARKER INK W/8 LABEUTIME OUT/RULER (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL & WRAP AAMI LEVEL Ill 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
Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (2) TOWELS ABSORBENT 15 X 20 (1) PENCIL CAUTERY PUSH BOTTOM (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) COVER TABLE REINFORCED 50 X 90 (1) CUP DENTURE 8oz TEAL WITH LID (1) RULER ACCU-6 (6) TOWELS CLOTH HUCK C BLUE (1) TUBE SUCTION CONNECT (1) DRAPE BREAST/CHEST (2) LITE GLOVE 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
Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWELS ABSORBENT 15" X 20" (1 ) DRAPE INSTRUMENT MAGNETIC 10" X 16" (1 ) TRAY HALF DEEP (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1 ) SHEET ENT SPLIT 110" X 77" (1 ) COVER TABLE REINFORCED 44" X 78" (20) GAUZE SPONGES 4" X 4" 12PLY (6) TOWELS CLOTH HUCK C BLUE (1 ) CUP DENTURE 8oz TEAL WITH LID (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) LITE GLOVE 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
Tummy Pack MRT, code 900-2657, contains: (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM ( 1) NEEDLE ULTRACLEAN 1" (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG ( 1) BOWL UTILITY QUART 32oz (1 ) MAYO STAND COVER REINFORCED (1 ) TABLE COVER REINFORCED 50" X 90" (1 ) DRAPEBREASTICHEST SMS ( 1) RULER 6" CLEAR (6) TOWEL CLOTH HUCK C (BLUE) (2) TOWELS ABSORBENT 15" X 20" ( 1) TUBE SUCTION CONNECT ~" X 12' ( 1) DENTURE CUP 8oz WITH LID (2) SKIN MARKER INK WITH 8 LABEL (2) LITE GLOVES 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
LAPAROTOMY PACK - (I) UTILITY BOWL 16oz ( I) ELECTRODE DUAL DEPRES./GROUNDPAD (I) UTILITY BOWL 32oz ( I) GOWN IMP. REINFORCED XL SMS AAMI Ill (2) NEEDLE & BLADE COUNTER I OC MAG/CLEAR ( I) DRAPE LAPAROT ABDOM WITH POUCH (2) TOWELS ABSORBENT 15" x 20" ( I) TIME OUT BEACON NON WOVEN (4) DRAPE UTILITY (I) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (I) MAYO STAND COVER REINFORCED ( I) SUTURE BAG FLORAL (I) TABLE COVER REINFORCED 50" X 90" ( I) GOWN IMP EXTRA REINF LGE TOWEUWRAP (2) DRAPE SHEET 42" X 55" SMS (I) CAUTERY TIP POLISHER (I) CAUTERY PENCIL ROCKER SWITCH ( I) BAG GLASSINE (I) SURGICAL BLADE# 10 STAINLESS STEEL 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
Breast Pack MRT, code 900-2658, contains: ( 1) BULB SYRINGE 60cc (2) GOWN SOFT SMS STD XLGE SET IN SLEEVE ( 1) CAUTERY PENCIL PUSH BOTTOM (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK ( 1) NEEDLE and BLADE COUNTER 20c FOAM/MAG ( 1) UTILITY BOWL QUART 32oz ( 1) MAYO STAND COVER REINFORCED ( 1) TABLE COVER REINFORCED 50 X 90 ( 1) DRAPE BREAST/CHEST SMS ( 1) YANKAUER SUCTION TUBE W/0 VENT ( 1) TUBE SUCTION CONNECT Y ( 1) RULER 6 CLEAR (6) TOWEL CLOTH HUCK C (BLUE) (2) TOWEL ABSORBENT 15 X 20 (2) SKIN MARKER INK W/ LABEL ( 1) DENTURE CUP 8oz W/LID (2) LITE GLOVES 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
Breast Pack BOD, code 900-3029, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTTOM (1) SYRINGE BULB 60CC (1) TUBE SUCTION CONNECT%" X 12' (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) COVER TABLE REINFORCED 50" X 90" (1) CUP DENTURE 8oz TEAL WITH LID (1) RULER (6) TOWEL CLOTH HUCK BLUE (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) DRAPE BREAST/CHEST (2) LITE GLOVE 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
Liposuction Pack BOD, code 900-3028, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) LITE GLOVES LIF (2) TOWEL ABSORBENT 15" X 20" L/F (1) NEEDLE HYPODERMIC 27G X 1 %" LIF (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED L/F (1) PVP SCRUB SOLUTION 4oz (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (2) COVER TABLE REINFORCED 44" X 78" LIF (1) CUP DENTURE 8oz TEAL WITH LID (12) TOWEL CLOTH HUCK C BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (1) TUBING INFILTRATION PERISTALTIC PUMPS (4) CLAMP TOWEL LIF (3) SHEET DRAPE 70" X 100" 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
Liposuction Pack MRT, code 900-2656, contains: (1) NEEDLE HYPODERMIC 27 X 1 LIF (1) UTILITY BOWL QUART 32oz LIF (1) MAYO STAND COVER REINFORCED LIF (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF ( 1) PVP SCRUB SOLUTION 4oz BOTTLE (20) GAUZE SPONGES 4 X 4 (12) TOWEL CLOTH HUCK (BLUE) (4) TOWEL CLAMP (3) TIP ABSORBENT APPLICATOR STICK SPONGE LIF ( 1) SAFETY SCALPEL 15 (3) DRAPE SHEET 70 X 100 LIF (2) TOWEL ABSORBENT 15 X 20 LIF (2) TABLE COVER REINFORCED 44 X 78 LIF (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (1) DENTURE CUP 8oz WITH LID (2) SYRINGE 10ML W/FIXED M/L DARK GREEN (1) TUBING INFILTRATION PERISTALTIC PUMPS (2) LITE GLOVES 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
Face Pack MRT, product code 900-2654, contains: (2) GOWN SOFT SMS STD X-LARGE SET IN SLEEVE LIF (2) TOWELS ABSORBENT 15 X 20 LIF (1) DRAPE INST. MAGNETIC 10 X 16 LIF (1) TRAY HALF DEEP (1) COVER MAYO STAND REINFORCED LIF (1) SHEET ENT SPLIT 110 X 77 SMS LIF (1) COVER TABLE REINFORCED 44" X 78" LIF (20) GAUZE SPONGES 4 X 4 12PLY L/F (6) TOWELS CLOTH HUCK C BLUE L/F (2) TIP ABSORB. APPLIC STICK SPONGE LIF (1) STRIP STERI CLOSURE LIF (1) CUP DENTURE 8oz. TEAL WITH LID (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER LIF (2) SYRINGE 10ML DARK GREEN (1) SYRINGE 10ML YELLOW L/F (1) LITE GLOVE LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG 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
ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53" X 77" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET SPLITW/ADHES 108" X 77" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) TIME OUT BEACON NON WOVEN (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill (1) POLISHER CAUTERY TIP (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLIBLADE 20C FOAM/MAG (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE T/WRAP AAMI LEVEL Il (1) BAG GLASSINE PLAIN (1) ELECTRODE DUAL DEPRES 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
TRAATEK NEURO PACK (4)TOWEL ABSORBENT 15" X 20" LIF ( 1) MAYO STAND COVER REINFORCED LIF ( 1) CAUTERY TIP POLISHER LIF (8) TOWEL CLOTH HUCK (BLUE) ( 1) BULB SYRINGE 60cc LIF ( 1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE (2) LITE GLOVE ( 1) TUBE SUCTION CONNECT. Y.." X 12' LIF ( 1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF ( 1) DRAPE % ECONOMY 53" X 77" LIF ( 1) SHEET SPLIT W/ADHESIVE 77" x 146" (2) GOWN XL SMS IMPERVIOUS REINFORCED LIF (2) SYRINGE 60ml WITHOUT NEEDLE LUER LOCK LIF ( 1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF ( 1) STAPLE SKIN 35 WIDE LIF ( 1) TRAY MAYO LARGE (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF ( 1) SOLUTION SURGICAL DURAPREP 26ml LIF ( 1) Pk. NEUROPATTIES 0.45MM 10ea/pk ( 1) Pk. NEUROPATTIES 0.35MM 10ea/pk 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
SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2) DRAPE SHEET 70" X 100" (1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST. (1) STOCKINETTE 6 X 48" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (1) SCALPEL WEIGHTED SAFETY# 11 (1) BULB SYRINGE 60cc (1) DRAPE BEACH CHAIR SHOULDER ARTHROSCOPY (10) LAP SPONGE PREWASH 18" X 18" XRD (2) U-DRAPE 60" X 70" WITH TAPE SPLIT (2) DRAPE SHEET 41" X 58" SMS (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) TABLE COVER REINFORCED 50" X 90" (1) COBAN WRAP TAN 4" X 5yds (1) TIME OUT BEACON NON WOVEN (2) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL IV (2) MAYO STAND COVER REINFORCED (1) SKIN MARKER INK WITH 8 LABEL (1) TUBE CONNECTING SUCTION X" X 12' (1) MAYO TRAY SMALL ( 1) CAMERA COVER W/ELAST. 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
HIGADO & PANCREA PACK - (1) BAG SUTURE FLORAL (2) YANKAUER SUCTION TUBE WITHOUT VENT (4) DRAPE UTILITY WITH TAPE (6) TOWELS CLOTH HUCK BLUE (1) SHEET DRAPE 41 " X 58" SMS (1) MAYO TRAY LARGE (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE INCISE ANTIMICROBIAL 23" X 17" (1) DRAPE BARIATRIC (1) BLADE SURGICAL #10 STAINLESS STEEL (1) CUP SPECIMEN WITH CAP 4oz (1) BLADE SURGICAL #15 STAINLESS STEEL (30) LAP SPONGE PREWASH 18" X 18" XRD (1) STRIP STERI CLOSURE W X 4" (1) POLISHER CAUTERY TIP (1) NEEDLE ECLIPSE 22 X 1 Y2 (4) TOWEL ABSORBENT 15" X 20" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (2) LITE GLOVE (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLE/BLADE 60C FOAM/STR/MAG/STR (1) FORCE TRIVERSE (1) SYRINGE BULB 60CC (1) BLADE EXTENDED ELECT. 16.51cm (2) TUBE SUCTION CONNECT Y." X 12' (2) CHLORAPREP 26ML APPLICATOR TEAL (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE 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
Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII (4) TOWELS ABSORBENT 15" X 20" LIF (1) PENCIL CAUTERY PUSH BOTTOM LIF (1) SYRINGE 60ML LUER LOCK WITHOUT NEEDLE L/F (1) TUBE SUCTION CONNECT X" X 12' LIF (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG L/F (1) COVER MAYO STAND REINFORCED LIF (2) SKIN MARKER INK WITH 8 LABEL/TIME OUT RULER LIF (2) BOWL UTILITY QUART 32oz. (1) COVER TABLE REINFORCED 50" X 90" LIF (1) RULER LIF (4) DRAPE UTILITY LIF (2) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) DRAPE BREAST/CHEST SMS LIF (1) GAUZE KERLIX 4.5"X 4 1/8 YD 6PL Y L/F (2) LITE GLOVES (5) SPONGE LAP PREWASH 18" X 18" XRD LIF (1) SHEET DRAPE 42" X 57" SMS LIF (1) SHEET DRAPE 70" x 100" 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