ClearanceBrief
Panels › General Hospital › Product code FMI · Class 2

Needle, Hypodermic, Single Lumen

Regulation 880.5570

13510(k)s in 12 months (694 all time)
3recalls in 12 months (311 all time)
283recalls that name a 510(k)
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Top companies in FMI

Decided510(k)Device and applicantCode
Jul 5, 1995K951736LOCK-UP
Medline
FMI
Jun 29, 1995K950899LABORATORY SHARPS BARREL
Biosystems
FMI
Jun 16, 1995K946041CARDICO SHARPS CONTAINERS (1.5, 5, 9, 13, 21QTS.)
Cardico, Inc.
FMI
Jun 16, 1995K943626ISOLYSER SHARPS MANAGEMENT SYSTEM SMS
Thantex Specialties, Inc.
FMI
May 23, 1995K951515MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER
Sherwood Medical Co.
FMI
May 17, 1995K946084VANGUARD
Vanguard Container Corp.
FMI
May 11, 1995K950466B-D ULTRA-FINE II PEN NEEDLE
Bd Becton Dickinson Vacutainer Systems Preanalytic
FMI
Apr 21, 1995K925056SAFESHARPE (TM) DISPOSAL SYSTEM
Life Medical Technologies, Inc.
FMI
Apr 14, 1995K950159SURESHARP
Gainor Medical U.S.A., Inc.
FMI
Apr 10, 1995K945825SECURE SAFETY INSERT
Syncor Intl. Corp.
FMI
Mar 15, 1995K945809MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)
Sherwood Medical Co.
FMI
Mar 3, 1995K943771MEDX REUSABLE SHARPS CONTAINER
Bfi- Medical Waste Systems
FMI
Jan 31, 1995K944680SPLIT TOP WING NEEDLE CAP WITH OPTIONAL TUBING ANCHORS (AND APPROPRIATE RECAP DEVICE
Researched, Novel Medical Devices (Rn/Md)
FMI
Jan 27, 1995K944121SHARPS CONTAINER 18 GALLON
Bci, Inc.
FMI
Jan 26, 1995K946027BIG PHIL
Biomedical Waste Systems, Inc.
FMI
Jan 26, 1995K941031TOHP-CAP
Jrm Ent., Inc.
FMI
Jan 11, 1995K944757PISTON SYRINGES
Bd Becton Dickinson Vacutainer Systems Preanalytic
FMI
Dec 29, 1994K945284TRUJECT
Clive Craig Co.
FMI
Dec 14, 1994K945276PRO-TEC DISPOSABLE SHARPS CONTAINERS 5G
Pro-Tec Containers, Inc.
FMI
Dec 14, 1994K945275PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1
Pro-Tec Containers, Inc.
FMI
Dec 14, 1994K945274PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80
Pro-Tec Containers, Inc.
FMI
Dec 14, 1994K945273PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2
Pro-Tec Containers, Inc.
FMI
Dec 14, 1994K943794MX4000
Bfi- Medical Waste Systems
FMI
Dec 14, 1994K943740ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)
Premium Plastics, Inc.
FMI
Dec 12, 1994K943679UNIVEC NONRESUSABLE LOCKING SYRINGE
Univec, Inc.
FMI
Dec 2, 1994K944114PHLEBOTOMY UNIT SHARPS A GATOR
Devon Industries, Inc.
FMI
Dec 2, 1994K943892POINT OF USE SHARPS A GATOR
Devon Industries, Inc.
FMI
Dec 2, 1994K942179PRO-TEC DISPOSABLE SHARPS CONTAINERS
Pro-Tec Containers, Inc.
FMI
Nov 28, 1994K943722CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS
Baxter Healthcare Corp
FMI
Nov 28, 1994K943139B-D GUARDIAN ONE PIECE SHARPS COLLECTORS
Med-Safe Systems, Inc.
FMI
Nov 7, 1994K944230DIAL MEDICAL SUPPLY SHARPS CONTAINER
Regulatory & Marketing Services, Inc.
FMI
Nov 7, 1994K943141B-D GUARDIAN POINT OF USE HORIZONTAL AND SIDE ENTRY SHARPS COLLECTORS
Med-Safe Systems, Inc.
FMI
Nov 7, 1994K943140B-D GURADIAN CHEMOTHERAPY SHARPS COLLECTORS
Med-Safe Systems, Inc.
FMI
Nov 7, 1994K943137B-D/BFI MAIL DISPOSAL SERVICE
Med-Safe Systems, Inc.
FMI
Nov 7, 1994K943136B-D GUARDIAN POINT-OF-USE VERTICAL ENTRY SHARPS COLLECTORS
Med-Safe Systems, Inc.
FMI
Nov 7, 1994K943135MED-SAFE INSULIN SHARPS CONTAINER
Med-Safe Systems, Inc.
FMI
Nov 7, 1994K943134B-D GUARDIAN NESTABLE SHARPS COLLECTORS
Med-Safe Systems, Inc.
FMI
Oct 31, 1994K943683B-D SAFE-CLIP
Becton Dickinson Consumer Products
FMI
Oct 14, 1994K943575B-D GUARDIAN NESTABLE SHARPS COLLECTORS
Bd Becton Dickinson Vacutainer Systems Preanalytic
FMI
Sep 19, 1994K942903SHARPS-TAINER SMALL OPENING
Winfield Co., Inc.
FMI
Sep 19, 1994K942901SHARPS-TAINER LARGE OPENING
Winfield Co., Inc.
FMI
Sep 14, 1994K940961MONOJECT LUER ADAPTER
Sherwood Medical Co.
FMI
Sep 9, 1994K943485MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER
Sherwood Medical Co.
FMI
Aug 29, 1994K943496MONOJECT TRAY SIZE SHARPS CONTAINER
Sherwood Medical Co.
FMI
Aug 25, 1994K942937SHARPSAFE CAT NO. 4105, 4115 AND 4120
Smiths Industries Medical Systems, Inc.
FMI
Aug 25, 1994K942624LOK-ON NEEDLE DISPOSAL CONTAINER
Medical Safety Products, Inc.
FMI
Aug 23, 1994K943578MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARPS CONTAINER
Sherwood Medical Co.
FMI
Aug 23, 1994K942054SHARPS-TAINER
Winfield Industries
FMI
Aug 17, 1994K943605BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS
Baxter Healthcare Corp
FMI
Aug 17, 1994K943594BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS
Baxter Healthcare Corp
FMI

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