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)
Top companies in OJH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Customed, 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 |
OJH | None listed |
| Dec 16, 2014 | Customed, 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 |
OJH | None listed |
| Dec 16, 2014 | Customed, 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 |
OJH | None listed |
| Dec 16, 2014 | Customed, 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 |
OJH | None listed |
| Dec 16, 2014 | Customed, 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 |
OJH | None listed |
| Dec 16, 2014 | Customed, 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 |
OJH | None listed |
| Dec 16, 2014 | Customed, 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 |
OJH | None listed |
| Dec 16, 2014 | Customed, 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 |
OJH | None listed |
| Dec 16, 2014 | Customed, 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 |
OJH | None listed |
| Dec 16, 2014 | Customed, 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 |
OJH | None listed |
| Dec 16, 2014 | Customed, 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 |
OJH | None listed |
| Dec 16, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
| Aug 29, 2014 | Customed, 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 |
OJH | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.