Panels › General, Plastic Surgery › Product code LRO · Class 2
General Surgery Tray
Regulation 878.4370
0510(k)s in 12 months (110 all time)
103recalls in 12 months (1,084 all time)
141recalls that name a 510(k)
Top companies in LRO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2014 | Customed, Inc 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 & BLAD Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc 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 Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc 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 Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Plastic Pack Customed, code 900-2582
(1) GOWN LGE SMS IMP REINF L/F
(1) GOWN SURG. REINF LGE TMJRAP LIF
(1) MAYO STAND COVER REINF LIF
(1) TABLE COVER REINF 50" X 90" LIF (4)
(1) PVP PAINT 8" STICK Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Universal Pack II (2) Customed 900-2509
(1) MAYO STAND COVER REINFORCED
(2) DRAPE SIDE 42" X 76" WITH TAPE
(1) DRAPE BOTTOM ABSORBENT REINFORCED 71" X 62" STD SMS WITH TAPE
(1) DRAPE TOP W/ADHESIVE 1 Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Extremity Pack, code 900-2615, contains:
(5) LAP SPONGE PREWASH 18" X 18" XRD
(1) ELASTIC BANDAGE WITH VELCRO 4 X 5
(2) BLADE SURGICAL# 15 STAINLES STEEL
(4) DRAPE UTILITY WITH TAPE
(1) GOWN XL SMS IM Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Gown Cool Impervious XLGE Breathable Customed, 900-2592:
(1) GOWN XL SURGICAL MICROCOOL
(1) WRAPPER 24" X 24"
(1) TOWELS ABSORBENT 15" X 20" LIF
Product Usage:
EO sterilized surgical convenient packs Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Laparotomy Pack, 900-2516, pack contains:
( I) TABLE COVER44" X 90"
( I) CAUTERY PENCIL PUSH BOTTOM
(4) TOWELS ABSORBENT 15" X 20" L/F
( I) BULB SYRINGE 60cc LIF
(4) DRAPE UTILITY WIT APE LIF
(I) S Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Minor Pack 900-2511, pack contains:
(1) GOWN XLGE SMS IMPERVIOUS REINFORCED AAMIIII
(10) GAUZE SPONGE 4" X 4" 16PLY XRD
(5) LAP SPONGE PREWASH 18" X 18" XRD
(1) DRAPE LAPAROTOMY W/POUCH 100" x 72" x Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc Urology Pack, 900-2510, package contains:
(2) TOWELS ABSORBENT 15X 20 UF
(1) DRAPE LITHO 11 0" X 63" W/LEGG/POUCH FEN UF
(10)GAUZE SPONGE 4" X 4" 12PL Y
(1) GOWN XL SMS IMPERVIOUS REINFORCED UF
(1) Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT:
(4) TOWEL ABSORBENT 15" X 20"
(2) GOWN XLARGE SMS IMPERVIOUS REINFORCED (1) COVER MAYO STAND REINFORCED
(2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILIT Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc ARTHROSCOPY PACK I (1)
CUSTOMED
CONTENTS:
(1) TOWELS ABSORBENT 15" X 20"
(1) GOWN XL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED
(1) U - DRAPE 60" X 70" WITAPE SPLIT 6 X 21
(1) Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc BASIC PACK 1 (Ill) CUSTOMED
CONTENTS:
(1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE UTILITY WffAPE
(2) TOWELS ABSORBENT 15" X 20" (1) SUTURE BAG FLORAL
(1) DRAPE SHEET 42" X 57" SMS
(1) SHEET :X 57 Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc BASIC PACK IV (6) CUSTOMED
CONTENTS:
(3) TOWELS ABSORBENT 15" X 20"
(1) MAYO STAN COVER REINFORCED (1) DRAPE % ECONOMY 53" X 77"
(1) DRAPE SHEET 41" X 58" SMS
(4) UTILITY DRAPE W/TAPE (1) SUTU Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc CENTRAL LINE DRAPE PACK
1) MASK PROCEDUAL EAR LOOP 120MM HG V/B L/Free
(1) DRAPE SHEET 41" X 58" SMS L/Free
(1) CAP NURSE 21" GREEN BOUFFANT
(1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED CIRC/ Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc EXTREMITY ARM PACK
CONTENTS:
(1) STOCKINETTE IMPERVIOUS 14" X 48"
(1) GOBAN SELF-ADHERENT WRAP 6" X 5yds
(3) BANDAGE ELASTIC 4" X 5yds
(1) BANDAGE ESMARK 6" X 9
(1) UTILITY BOWL QUART 32oz
(1 Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc VAGINAL PROCEDURE PACK
CUSTOM ED
CONTENTS:
(1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF
(1) COVER MAYO STAND REINFORCED LIF ( Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc FACE PACK AESTHETIC SURGERY
AESTHETIC SURGERY
CONTENTS:
(15) APPLICATOR COTION 6" WOOD
(60) GAUZE SPONGE 4" X 4" 16 PLY SOFT LIF (2) NEEDLE SPINAL ANEST 22G X 3 Y2 LIF
(8) TOWELS CLOTH HUCK BLU Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc LIPOSUCTION PACK AESTHETIC SURG.CENTER
CONTENTS:
(1) BLADE SURG. #11 CARBON STEEL (3) * GLOVE PERRY SURG. # 7LATEX (15) SPONGE LAP PREWASH 18" X 18" XRD L/F (4) * GLOVE PERRY SURG. # 7 LATEX
(1) TA Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc CERVICAL PACK
ADVANCED AMBULATORY SURGICAL CENTER
CONTENTS:
(1) COVER TABLE REINFORCED 50" X 90" (1) COVER FLUORO 30" X 30" WITH RUBBER BAND (8) TOWELS CLOTH HUCK BLUE (1) SHEET :Y. 60" X 77" DRAPE Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc CENTRAL LINE FULL BODY DRAPE
CUSTOMED
CONTENTS:
(1) WRAPPER 30" X 30"
(2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg
(2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS ABSORBENT 15" X 20"
(2) GOWN LARGE STAN Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc SURGICAL PACK
CONTENTS:
(1) SUTURE BAG FLORAL
(1) WRAPPER 30" X 30"
(2) UTILITY BOWL 16oz
(1) TRAY ORGANIZER FULL DEEP
(1) SPECIMEN CONTAINER 4oz W/LID & LABEL (1) YANKAUER SUCTION TUBE WIT Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc HIP PACK
CONTENTS:
(2) TOWELS ABSORBENT 15" X 20"
(2) GOWN XL SMS IMPERV. REINFORCED
(1) MAYO STAND COVER REINFORCED (1) SUTURE BAG
(1) DRAPE UTILITY WITH TAPE
(1) STOCKINETTE IMPERV. 14" X Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc LITHOTOMY PACK
CONTENTS:
(2) TOWELS ABSORBENT 15" X 20"
(2) LEGGINGS W/7'' CUFF 30" X 42" CSR
(1) DRAPE UNDERBUTTOCK WITH POUCH 44" x 35"
(1) DRAPE ABDOMINAL WITH TAPE 40" X 54"
(1) DRAPE UTILITY Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc GENERAL PACK -
CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF
(1) MAYO STAND COVER REINFORCED LIF
( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF
(2) UTILITY BOWL 16 oz. LIF
(1) GLASINE BAG PLAIN
( 1) SUTU Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc 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" Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc 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) T Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc ENDOVENOUS CUSTOM PACK - CUSTOMED
(1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F
(1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF
(2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF
(20) GAUZE SPONGE 4" X 4" 12PL Y LIF
(3) Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc UNIVERSAL PACK -
(1) UTILITY BOWL 16oz.
(1) NEEDLE SPINAL ANEST. 22G X 31!2
(1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK LIF
(2) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF
(1) SYRINGE 30cc WITHOUT NEEDLE L Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc AV FISTULA PACK-
(1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS
(3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV
(1) DRAPE SHEET 42" X 57" SMS
(4) DRAPE UTILITY WITH TAPE LIF
(1 0) GAUZE SPONGE 4 Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc 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 Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc BASIC PACK -
(1) TABLE COVER REINF. LIF
(1) MAYO STAND COVER REINF. LIF
(2) TOWELS ABSORBENT LIF
(10) GAUZE SPONGES XRD 4" X 4" 12PLY
(2) DRAPE SHEET 41" X 58" SMS
(4) DRAPE UTILITY WIT APE L/F
EO Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc ARTHROSCOPY PACK-
(1) TABLE COVER REINFORCED 50" X 90"
(1) PRE PAD WITH CUFF
(2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill
(1) GOWN IMPERV. EXTRA REINFORCED LGE TNVRAP
(1) MAYO STAND COVER REINFORC Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc UROLOGY PACK -
(3) TOWELS ABSORBENT 15" X 20" UF
(1) WASH BASIN ROUND 6QT.
(1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN
(1) BAG URINARY DRAINGAGE 2000ml ANTI-REFLUX
(1) BAG SUTURE FLORAL
(1) GOWN S Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc UROLOGY PACK -
(4) ABSORBENT TOWELS UF
(2) GOWN SURGICAL POLY-REINF. BREATHABLE XL LEVEL IV
(1) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F
(1) TUR Y SET, 81 "2 .1M REGULAR CLAM
(1) TABLE COVER 44" x 90" Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc MINOR LAPAROTOMY PACK -
(1) TABLE COVER 50" X 90" REINFORCED LIF
(1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP
(1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF
(3) TOWELS ABSORBENT 15" X 20" LIF
(1) YA Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc UNIVERSAL PACK -
(1) TRAY ORGANIZER FULL DEEP
(1) ANESTHESIA SPINAL NEEDLE 22G X 3 ~ UF
(1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK UF
(1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK UF
(1) NEEDLE HYPODERMIC Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc DRESSING CHANGE - CUSTOMED-
(2) GLOVE MED. FREETOUCH VYNIL POWDER FREE
( I) DRESSING TEGADERM 3 Y2 X 4 Y2
( I) MASK PROCEDURAL YELLOW 80MM HG L/F
(4) GAUZE 4" X 4" 4PLY
( I) ALCOHOL PREP PAD MED
Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc UROLOGY PACK-
(10) GAUZE SPONGE 4" X 4" 16PLY
(1) TUBE SUCTION CONNECT Y." X12'
(1) SYRINGE 30cc WITHOUT NEEDLE ULOCK
(1) BASIN RING
(1) TUR Y SET, 2 LEAD, ST.
(1) BAG SUTURE FLORAL
(1) GOWN SURG. Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc LAPAROSCOPY CHOLECYSTECTOMY PACK-
(1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF
(2) ABSORBENT TOWELS 15" X 20" UF
(1) MAYO STAND COVER REINFORCED UF
(4) BANDAGE ADHESIVE W' x 3" L I F
(4) DRAPE UTILITY WI Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc CIRUGIA CARDIOVASCULAR - CASE CART -
(1) CIRUGIA CARDIOVASCULAR (PREPARACION)
(1) CIRUGIA CARDIOVASCULAR (ENFERMERA CIRCULANTE)
(1) CIRUGIA CARDIOVASCULAR (INDUCCION)
(1) OPEN HEART TRAY
EO sterilize Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc REYITO UROLOGY PACK -
(2) GOWN IMP. REINFORCED X-LARGE SMS
(2) TOWELS ABSORBENT UF
( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF
( I) SYRINGE 30cc W/0 NDL. LUER LOCK UF
( I) BAG SUTURE
(I) TABLE C Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc UMBILICAL VESSEL CATHETER KIT - CUSTOMED-
(1) PAPER TAPE MEASURE DISP. 24"
(1) FENESTRATED DRAPE 18" x 26" LIF
(1) NEEDLE HOLDER BAUMGARTNER 5"
(2) HALSTED MOSQUITO CVD 5" SERRAT
(1) ADSON FORCEP TIS Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc PLASTIC SURGERY PACK -
LABEL SAMPLE
CONTENTS:
(2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF
(10) GAUZE SPONGE 4" X 4" 16 PLY LIF (1) TABLE COVER 44" X 90"
(1) DRAPE SHEET 70" Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc VEIN PACK -
(1) GOWN STANDARD LARGE SMS VELCRO/NECK
(3) LAP. SPONGES PREWASH XRD LIF
(1) EXTREMITY SHEET ABS LIF
(1) WRAPPER 36" X 36"
(1) IMP. STOCKINETTE 14" X 48" LIF
EO sterilized surgical conve Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc PEDIATRIC LAP PACK -
( I) SHEET MINOR LAP 102" X 121" X 78"
( I) MAYO STAND COVER REINFORCED LIF
( I) TABLE COVER REINFORCED 50" X 90" LIF
(2) DRAPE SHEET 41 " X 58" SMS
(2) TOWELS ABSORBENT 15" x 20 Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc PREMIUM UROLOGY PACK - CUSTOMED-
(1) LITHOTOMY DRAPE W/POUCH ANESTH.
(2) ABSORBENT TOWELS UF
(1) MAYO STAND COVER REINFORCED UF
(1) URINARY DRAINAGE BAG 2000ml ANTI-REFLUX UF
(1) GOWN SURG. REINFORC Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc PHACO PACK -
(10) GAUZE SPONGE 4" X 4" 12PLY
(2) SYRINGE 3cc W/NDL. 21G X 1 %"
(2) MEDICINE CUP 2 oz.
(1) OPHTHALMIC DRAPE W/POUCH
(1) GOWN STANDARD LGE.SMS (1) GOWN NON REINF. Lge. T/Wrap SMS
(1) Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc STRABISMUS & PLASTIC PACK - (1) TABLE COVER REINFORCED 44" X 78" UF
(2) GOWN STANDARD LARGE SMS
(3) TOWELS ABSORBENT 15" X 20" UF
(1) MAYO STAND COVER REINFORCED UF
(1) DRAPE SHEET 41" X 58" SMS
(4) D Terminated |
LRO | None listed |
| Aug 29, 2014 | Customed, Inc 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 Terminated |
LRO | None listed |
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