|
91516
|
Z-1900-2010
|
Terminated
|
LXH
|
2010-04-20
|
Smith & Nephew Inc
|
GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA
Drill guide used as manual surgical instrument during knee replacement surgeries.
|
|
91904
|
Z-1838-2010
|
Terminated
|
JCT
|
2010-05-17
|
Boston Scientific Corporation
|
Ultraflex Tracheobronchial Stent System. Uncovered - 20/60 Catalog Number: M00569300. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Indicated for the use in the treatment of tracheobronchial structures produced by malignant neoplasms.
|
|
90249
|
Z-1946-2010
|
Terminated
|
KMI
|
2010-03-26
|
Stanley Security Solutions, Inc.
|
Tabs Professional Monitor Without Pull Cord or wall bracket, Model 25025, Stanley Senior Technologies, Lincoln, NE.
|
|
91951
|
Z-1920-2010
|
Terminated
|
HPS
|
2010-04-08
|
Mira, Inc.
|
MIRA CR4060 68 mm Finger Probe
68mm surf ace x 37mm Length
Intended for the destruction of tumors.
|
|
91756
|
Z-1953-2010
|
Terminated
|
MBI
|
2010-03-31
|
Biomet, Inc.
|
Toggleloc Artificial ligament fixation device ZIPLOOP Technology Implant Kit, Sterile, REF 909848, Biomet Sports Medicine Warsaw, IN.
Intended for soft tissue to bone fixation.
|
|
90250
|
Z-1947-2010
|
Terminated
|
KMI
|
2010-03-26
|
Stanley Security Solutions, Inc.
|
Tabs Professional Monitor with Wire Bracket and Push Button Reset, Model 25223, Stanley Senior Technologies, Lincoln, NE.
|
|
91838
|
Z-1884-2010
|
Terminated
|
LJT
|
2010-05-13
|
Navilyst Medical, Inc
|
Navilyst Medical, Inc. Vaxcel(TM) Port titanium Standard Port with 9F Polyurethane Catheter (1.8 mm/2.8 mm), REF Catalog No. 45-315, UPN Product No. M001453150, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
|
|
92157
|
Z-1938-2010
|
Terminated
|
FKG
|
2010-03-16
|
Centurion Medical Products
|
Dialysis Tray, SP560, Sterile, Micropore Surgical Tape, Single Use Rolls, Tri-State Hospital Supply Company Manufacturers of Centurion Healthcare Products Howell, MI
|
|
88626
|
Z-1943-2010
|
Terminated
|
JEY
|
2009-10-05
|
Biomet Microfixation, Inc.
|
BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***.
Bone screws used along with implantable bone plates for oral, cranio-maxillofacial procedures.
|
|
91833
|
Z-1879-2010
|
Terminated
|
LJT
|
2010-05-13
|
Navilyst Medical, Inc
|
Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Plastic Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-366, UPN Product No. M0 01453660, Sterile, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
|
|
91006
|
Z-2166-2010
|
Terminated
|
DXN
|
2009-02-02
|
Zoe Medical Incorporated
|
The Well@Home Monitor by Patient Care technologies
Model 179-2150
Intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility on a spot check basis.
|
|
92492
|
Z-2153-2010
|
Terminated
|
DTR
|
2010-06-08
|
Terumo Cardiovascular Systems Corp
|
Terumo Cardiovascular Procedure Kit Custom
X-COATED ADULT PRESTIGE PACK
P/N 71544-01
|
|
92257
|
Z-2137-2010
|
Terminated
|
KPE
|
2010-05-26
|
Baxa Corporation
|
Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation.
|
|
92285
|
Z-2148-2010
|
Terminated
|
KPE
|
2010-05-26
|
Baxa Corporation
|
Exacta - Mix Valve Set, Six Inlet, Tubing Kit w/Calibration Bag, Fluid Path is sterile and non-pyrogenic in unopened, undamaged package, 250 mL, Order No. REF: 706D, Baxa Corporation.
|
|
91227
|
Z-2035-2010
|
Terminated
|
KWA
|
2010-03-05
|
Depuy Orthopaedics, Inc.
|
DePuy ASR 100 Acetabular Implant, 52 mm, 999800752, sterile, DePuy International, Ltd, Leeds, United Kingdom.
|
|
92381
|
Z-2019-2010
|
Terminated
|
KNW
|
2009-09-01
|
Medical Device Technologies, Inc.
|
Angiotech Pediatric Bone Marrow Needle.
Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k
K980196.
MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A.
Intended Use: Pediatric Bone Marrow Needle
|
|
91282
|
Z-2059-2010
|
Terminated
|
KWA
|
2010-03-05
|
Depuy Orthopaedics, Inc.
|
DePuy ASR 300 Acetabular Implant, 70 mm, 999830770, sterile, DePuy International, Ltd, Leeds, United Kingdom.
|
|
91252
|
Z-2047-2010
|
Terminated
|
KWA
|
2010-03-05
|
Depuy Orthopaedics, Inc.
|
DePuy ASR 300 Acetabular Implant, 46 mm, 999830746, sterile, DePuy International, Ltd, Leeds, United Kingdom.
|
|
91251
|
Z-2046-2010
|
Terminated
|
KWA
|
2010-03-05
|
Depuy Orthopaedics, Inc.
|
DePuy ASR 300 Acetabular Implant, 44 mm, 999830744, sterile, DePuy International, Ltd, Leeds, United Kingdom.
|
|
91225
|
Z-203-2010
|
Terminated
|
KWA
|
2010-03-05
|
Depuy Orthopaedics, Inc.
|
DePuy ASR 100 Acetabular Implant, 50 mm, 999800750, sterile, DePuy International, Ltd, Leeds, United Kingdom.
|