ClearanceBrief
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)
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Top companies in FWZ

DateFirm and productCodeLinked 510(k)
Mar 12, 2024Baxter Healthcare Corporation
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Open, Classified
FWZNone listed
Apr 19, 2017Mizuho 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
FWZNone listed
Nov 9, 2015Maquet 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
FWZNone listed
Nov 9, 2015Maquet 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
FWZNone listed
Feb 10, 2015Integra 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
FWZNone listed
Dec 16, 2014Customed, 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
FWZNone listed
Dec 16, 2014Customed, 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
FWZNone listed
Dec 16, 2014Customed, 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
FWZNone listed
Dec 16, 2014Customed, 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
FWZNone listed
Dec 16, 2014Customed, 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
FWZNone listed
Dec 16, 2014Customed, 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
FWZNone listed
Dec 16, 2014Customed, 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
FWZNone listed
Dec 16, 2014Customed, 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
FWZNone listed
Aug 29, 2014Customed, 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
FWZNone listed
Aug 29, 2014Customed, 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
FWZNone listed
Aug 29, 2014Customed, 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
FWZNone listed
Aug 29, 2014Customed, 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
FWZNone listed
Aug 29, 2014Customed, 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
FWZNone listed
Aug 29, 2014Customed, 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
FWZNone listed
Aug 29, 2014Customed, 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
FWZNone listed
Aug 29, 2014Customed, 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
FWZNone listed
Aug 29, 2014Customed, 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
FWZNone listed
Aug 29, 2014Customed, 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
FWZNone listed
Feb 21, 2013Integra 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
FWZNone listed
Jan 3, 2013Maquet 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
FWZNone listed
Dec 19, 2012Integra 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
FWZNone listed
Sep 26, 2012Integra 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
FWZNone listed
Sep 26, 2012Integra 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
FWZNone listed
Mar 13, 2012Mizuho 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
FWZNone listed
Sep 9, 2010Integra 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
FWZNone listed
Dec 2, 2009Maquet Inc.
Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories.
Terminated
FWZNone listed
Jan 15, 2009MAQUET 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
FWZNone listed
Jan 13, 2009Sterilmed 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
FWZNone listed
May 4, 2007Orthopedic 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
FWZNone listed
Sep 16, 2006J. 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
FWZNone listed
Apr 22, 2005Allen Medical Systems
Allen A-91000 Shoulder Positioner
Terminated
FWZNone listed
Jun 27, 2003The OR Group,Inc.
Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1
Terminated
FWZNone listed

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