Panels › General, Plastic Surgery › Product code FWZ · Class 1
Operating Room Accessories Table Tray
Regulation 878.4950
0510(k)s in 12 months (61 all time)
0recalls in 12 months (37 all time)
0recalls that name a 510(k)
Top companies in FWZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Customed, Inc | 0 | 18 |
| Mcconnell Orthopedic | 14 | 0 |
| Orthopedic Systems, Inc. | 8 | 1 |
| Integra LifeSciences Corp. | 0 | 4 |
| D.L. Nelson and Assoc., Inc. | 3 | 0 |
| MAQUET Inc. | 0 | 3 |
| Allen Medical Systems, Inc. | 1 | 1 |
| American Container Technology, Inc. | 2 | 0 |
| The Anspach Effort, Inc. | 2 | 0 |
| Devon Industries, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2024 | Baxter Healthcare Corporation STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 Open, Classified |
FWZ | None listed |
| Apr 19, 2017 | Mizuho OSI 216 Wilson Frame Pads, Model # 5319-37;
Used with Radiolucent Wilson Frames, model numbers 5319G and 5321G.
General and Plastic Surgery: These pads are used as a component of the Wilson Frames, whic Terminated |
FWZ | None listed |
| Nov 9, 2015 | Maquet Cardiovascular Us Sales, Llc Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany
The MAQUET Adjustable Positioning Elements are designed for the placement and positioning Terminated |
FWZ | None listed |
| Nov 9, 2015 | Maquet Cardiovascular Us Sales, Llc Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners.
The MAQUET Adjustable Positioning Elements are designed for the placement an Terminated |
FWZ | None listed |
| Feb 10, 2015 | Integra LifeSciences Corporation The MAYFIELD Ultra 360 Base Unit for head positioner, one unit per package.
Product Usage:
This product provides the ability to position and hold a patient head while the patient is in the prone, s Terminated |
FWZ | None listed |
| Dec 16, 2014 | Customed, Inc Arthoscopy Pack, Catalog # 900-982
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
FWZ | None listed |
| Dec 16, 2014 | Customed, Inc Arthroscopy Pack, Catalog # 900-902
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
FWZ | None listed |
| Dec 16, 2014 | Customed, Inc Arthroscopy Surgical Pack, Catalog # 900-740A
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
FWZ | None listed |
| Dec 16, 2014 | Customed, Inc Arthroscopy Pack, Catalog number 900-620.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
FWZ | None listed |
| Dec 16, 2014 | Customed, Inc Arthroscopy Pack, catalog #900-2609
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
FWZ | None listed |
| Dec 16, 2014 | Customed, Inc Knee Arthroscopy Pack, catalog #900-2123
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
FWZ | None listed |
| Dec 16, 2014 | Customed, Inc Arthroscopy Pack, Catalog number 900-1062.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
FWZ | None listed |
| Dec 16, 2014 | Customed, Inc Arthroscopy Pack, Catalog number 900-1042.
Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Terminated |
FWZ | None listed |
| Aug 29, 2014 | Customed, Inc Arthroscopy Pack,900-2609, contains:
(5) LAP SPONGE PREWASH 18" X 18" XRD
(1) SHEET ARTHROSCOPY T STD SMS WITH POUCH
(3) STRIPS TAPE 24" X 4"
(1) U-DRAPE 60" X 70" WITH TAPE SPLIT
(4) TOWELS ABSORBENT Terminated |
FWZ | None listed |
| Aug 29, 2014 | Customed, Inc KNEE ARTHROSCOPY PACK
CONTENTS:
(1) TOWEL ABSORBENT 15" X 20" L/F (10) GAUZE SPONGE 4" X 4" 16PLY
(1) SAFETY IV INTROCAN 18 X 1Y. ST. LIF (1) NEEDLE HYPODERMIC 18G X 1Y:z
(1) U-DRAPE 60" X 70 Terminated |
FWZ | None listed |
| Aug 29, 2014 | Customed, Inc PREMIUM ARTHROSCOPY PACK - CUSTOMED-
(1) ARTHROSCOPY SHEET T WITH POUCH LIF
(1) IMPERVIOUS STOCKINETTE
(3) STRIPS TAPE 24" X 4"
(1) DRAPE U WITH TAPE SPLIT
(2) TOWELS ABSORBENT 15" X 20" LIF
(1) GOW Terminated |
FWZ | None listed |
| Aug 29, 2014 | Customed, Inc ARTHROSCOPY PACK-
(1) VIDEO CAMERA DRAPE 13cm X 244cm LIF
(2) BANDAGE ELASTIC 6" X 5yrd. LIF
(1) U-DRAPE 60" X 70" WITH TAPE SPLIT
(1) DURAPREP SURGICAL SOLUTION 26m I LIF
(1) STOCKINETIE IMPERVIOUS
Terminated |
FWZ | None listed |
| Aug 29, 2014 | Customed, Inc ARTHROSCOPY PACK -
(1) SURGICAL DURAPREP SOLUTION 26ML LIF
(1) ESMARK BANDAGE
(1 ) ELASTIC BANDAGE 6" X 5yds LIF
(1) NEEDLE & BLADE COUNTER 20C FOAM/MAG
(1) TUBE SUCTION CONNECTING W X 12' LIF
(1) SH Terminated |
FWZ | None listed |
| Aug 29, 2014 | Customed, Inc ARHTROSCOPY PACK-
(1) U-DRAPE 60" X 70" WITH TAPE SPLIT
(1) GOWN IMPERVIOUS EXTRA REINFORCED X-LARGE
(1) TOWEL ABSORBENT 15" X 20"
(1) MAYO STAND COVER REINFORCED
(1) TABLE COVER REINFORCED 50" X 90" Terminated |
FWZ | None listed |
| Aug 29, 2014 | Customed, Inc ARTHROSCOPY PACK-
(2) ABSORBENT TOWELS 15" x 20" LIF
(1) TUBE SUCTION CONNECT Y.." X 12' LIF
(1) ELASTIC BANDAGE 6" X 5yrd. UF
(1) IMPERVIOUS STOCKINETTE 14" X 48"
(1) HUCK CLOTH TOWEL WHITE
(1) MAYO Terminated |
FWZ | None listed |
| Aug 29, 2014 | Customed, Inc ARTHROSCOPY PACK - (1) COVER MAYO STAND REINFORCED UF
(1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF
(1) TUBE SUCTION CONNECT ~" X 12' LIF
(1) SHEET ARTHROSCOPY T STD SMS WITH POUCH LIF
(1) STOCKINETIE Terminated |
FWZ | None listed |
| Aug 29, 2014 | Customed, Inc ARTHROSCOPY PACK - -
(1) MAYO STAND COVER REINFORCED LIF
(3) TOWELS ABSORBENT 15" X 20" LIF
(1) STOCKINETTE IMPERVIOUS 14" X 48" LIF
(1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF
(1) BLADE SURGICAL Terminated |
FWZ | None listed |
| Aug 29, 2014 | Customed, Inc ARTHROSCOPY PACK -
(1) MAYO STAND COVER REINFORCED LIF
(1 0) GAUZE SPONGES 4" X 4" 16PL Y
(1) TUBE SUCTION CONNECTING X" X 12' LIF
(1) IMP. STOCKINETTE
(1) SURGICAL BLADE #11 STAINLESS STEEL
(1) ANE Terminated |
FWZ | None listed |
| Feb 21, 2013 | Integra LifeSciences Corp. MAYFIELD Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227
The MAYFIELD Base Units are intended to Terminated |
FWZ | None listed |
| Jan 3, 2013 | Maquet Inc. Maquet Yuno Extension Table Device
Maquet GmbH & Co. KG
Kehler Strabe 31
Baden-Wuerttemberg
76437 Rastatt,Germany
Used to support the lower extremities immediately before during and after surgery. T Terminated |
FWZ | None listed |
| Dec 19, 2012 | Integra LifeSciences Corporation MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101.
The MAYFIELD Base Unit (A3101) is an operating room table accessory Terminated |
FWZ | None listed |
| Sep 26, 2012 | Integra Limited The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial st Terminated |
FWZ | None listed |
| Sep 26, 2012 | Integra Limited The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial st Terminated |
FWZ | None listed |
| Mar 13, 2012 | Mizuho Orthopedic Systems Inc Coupler System II
Mizuho Orthopedic Systems, Inc.
Union City, CA 94587
The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jac Terminated |
FWZ | None listed |
| Sep 9, 2010 | Integra LifeSciences Corporation Mayfield Infinity XR2 Base Unit, model A-2079, manufactured by Integra LifeSciences Corporation. The MAYFIELD Infinity XR2 Base Unit (A-2079) is an operating room table accessory intended to be used t Terminated |
FWZ | None listed |
| Dec 2, 2009 | Maquet Inc. Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0.
An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories. Terminated |
FWZ | None listed |
| Jan 15, 2009 | MAQUET Inc. Foot switch, Part Number 1009.81. Maquet GmbH & Co. KG, 76437 Rastatt, Germany.
The foot switches in the 1009.8 1 series are accessory components which can be connected to certain MAQUET operating t Terminated |
FWZ | None listed |
| Jan 13, 2009 | Sterilmed Inc Open & Unused Items - This refers to a sterilization service provided by by SterilMed, Inc. (devices were not reprocessed) for Class 1 and Class 2 devices that were opened, most likely in O. R. suite Terminated |
FWZ | None listed |
| May 4, 2007 | Orthopedic Systems Inc Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s Spinal Frame, which is an operating room tabletop that is attached to a table base. The Frame is used to supp Terminated |
FWZ | None listed |
| Sep 16, 2006 | J. Jamner Surgical Instruments, Inc. Ruggles Leyla Ball Joint Clamp, MODEL/CATALOG #: R2383 . The Leyla Ball Joint Clamp is part of the Table Mounting Hardware that is used with the Leyla Retractor System. The Leyla Table Mounting Har Terminated |
FWZ | None listed |
| Apr 22, 2005 | Allen Medical Systems Allen A-91000 Shoulder Positioner Terminated |
FWZ | None listed |
| Jun 27, 2003 | The OR Group,Inc. Allen Medical Systems PAL Pro Stirrups
Catalog Number: A-10051-A1 Terminated |
FWZ | None listed |
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