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Panels › General, Plastic Surgery › Product code OJH · Class 1

Orthopedic Tray

Regulation 878.4800

0510(k)s in 12 months (0 all time)
35recalls in 12 months (239 all time)
3recalls that name a 510(k)
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Top companies in OJH

DateFirm and productCodeLinked 510(k)
Dec 16, 2014Customed, Inc
Shoulder Pack, catalog #900-2616 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Extremity PACK, catalog #900-2615 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Hip & Knee Replacement, catalog #900-2614 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Arthroscopy Pack, catalog #900-2473 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Shoulder Arthroscopy Pack, catalog #900-2193 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Femoral Pack, catalog #900-2164 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Orthopedic tray, Catalog number 900-1985 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Hip Orthopedia Pack, Catalog number 900-1835. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Arthroscopy Pack, Catalog number 900-1832. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Femoral Pack, Catalog number 900-164. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
D&C Laparoscopy Pack, Catalog number 900-1476. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Dec 16, 2014Customed, Inc
Laminectomy Pack, Catalog number 900-1202. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
TLIF PACK SURGICAL CENTER, CODE 900-2918. CONTENTS: (2) SOLUTION SURGICAL DURAPREP 26ML UF (6) Pr. GLOVE SURG. DERMA PRENE # 8 PF UF (4) GOWN SOFT SMS STD XL SET IN SLEEVE UF (4) TOWELS
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER (1) BAG SUTURE FLORAL (1) U - DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1)
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
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)
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4" X 5YD WRAP TAN LATEX (2) U-DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TABLE COVER 44" X 90" (4) TOWE
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
Knee Arthroscopy Pack, code 900-2718, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (2) PADDING CAST SOFT ROLL 6 X 4yds. (1) GOBAN SELF-ADHERENT WRAP 6 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (2) STRIPS T
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) MAYO STAND COVER REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) STOCKINETTE IMPERVIOUS 12" X 48" (4) DRAPE U
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
Hip & Knee replacement pack, 900-2614, contains (1) CAUTERY TIP POLISHER UF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT Y." X 12' UF (1) TABLE COVER REINFORCED 50" X 90" UF (1) MAYO STAND COVER REI
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
ORTHOPEDIC PACK Ill (1) CUSTOMED CONTENTS: (1) GOWN XL SMS IMPERVIOUS REINFORCED (4) DRAPE UTILITY WffAPE (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL (1) DRAPE TOP W/ADHESIVE 108" X 50
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20" LIF (1) COVER MAYO STAND REINFORCED L/F ( 1) U- DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF (1) DRAPE % ECONOMY 53" X 77"
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
MINOR EXTREMITY PACK {2) CUSTOMED CONTENT: (1) GOWN LGE STD SMS VELC/NE T/WRAP (1) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) SHEET PLASTIC 44" X 65" (1) DRAPE% ECONOMY 53" X
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
KNEE ARTHROSCOPY PACK 4 CUSTOMED CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" (1) GOWN SURG REINFORCED LARGE TOWEL WRAP AAMI LEVEL Ill (1) PRE PAD CUFF (1) COVER MAYO STAND REINFORCED (1) BA
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
ORTHO PACK EXTREMITY CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 50" X 90" (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) U-DRAPE 60" X 70" Wf
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
LUMBAR PACK ADVANCED AMBULATORY SURGICAL CENTER CONTENTS: (1) COVER TABLE REINFORCED 50" X 90" UF (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (8) TOWELS CLOTH HUCK BLUE UF (1) SYRINGE 10CC WITHO
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
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) STOCK
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
FEMORAL PACK CONTENTS: (2) TOWELS ABSORBENT 15" X 20" LIF (2) DRAPE SHEET 42" X 57" SMS LIF (1) SAFETY IV INTROCAN 18 X 1X ST. LIF (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF (2) VESSEL LOOP
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
ORTHOPEDIC SURGICAL PACK HOSPITAL SAN CRISTOBAL CONTENTS: (I) CAUTERY TIP POLISH ER LIF (1) BAG SUTURE FLORAL (1) TUBE SUCTION CONNECT W' X 1 2' LIF (1) BAG GLASSINE (2) LITE GLOVE (1) TA
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO STAND COVER REINFORCED L/F (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH T
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
HIP ORTHOPEDIA PACK - (1) BLADE SURGICAL #15 STAINLES /STEEL (1) GOWN XL SMS IMPERVIOUS REINFORCED MMI Ill LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE U
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF ( I) TUBE SUCTION CONNECT \14'' X 12' LIF ( I) BAG GLASSINE LIF (2) LITE GLOVE LIF (2) TABLE COVER 50" X 90" REI
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" LIF ( I) SKIN MARKER INK W/8 LABEL ( I) CAUTERY TIP POLISHER LIF ( I) TUBE SUCTION CONNECT. W' X 12' LIF (6) DRAPE UTILIT
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF (1) NEEDLE HYPODERMIC 18G X 1 % LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BOWL UTILITY QUART 32oz. (2) SHEET DRAPE 41" X 58
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF (2) DRAPE SHEET 41 " X 58" SMS (1) BANDAGE GAUZE 4" STRETCH (1) NE
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z" (1) TUBE SUCTION CONNECT. }4" X 12' (1) DUR
Terminated
OJHNone listed
Aug 29, 2014Customed, Inc
IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y
Terminated
OJHNone listed

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