ClearanceBrief
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)
Get daily alerts for LROSample briefCSV

Top companies in LRO

DateFirm and productCodeLinked 510(k)
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed
Aug 29, 2014Customed, 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
LRONone listed

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.