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)
Get daily alerts for FMISample briefCSV

Top companies in FMI

Company510(k)sRecalls
Kendall Healthcare Products Co091
Multi-Med, Inc.275
Becton, Dickinson & CO1016
Cardinal Health 200, LLC023
International Medsurg Connection220
Bd Becton Dickinson Vacutainer Systems Preanalytic200
Vidacare Corporation142
B.Braun Medical, Inc.510
Terumo Europe N.V.150
Terumo Medical Corp.410
Decided510(k)Device and applicantCode
Jul 31, 2000K001690PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
Johnson & Johnson Medical, Inc.
FMI
Jun 20, 2000K993125SAFETYTIP MULTI-SAMPLE NEEDLE, SAFETYTIP BLOOD COLLECTION SYSTEM
Safety Medical Supply Int,., Inc.
FMI
May 18, 2000K001098PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01
Pro. Duct Health, Inc.
FMI
Apr 19, 2000K000455GETTIG GUARD
Gettig Pharmaceutical Instrument Co.
FMI
Apr 11, 2000K000441BODYGUARD
Vital Signs, Inc.
FMI
Mar 30, 2000K000369VACUFLOW+ BLOOD COLLECTION SET, MODEL 52221/3/5; VACUFLOW+ WITH HOLDER BLOOD COLLECTION SET, MODEL 82021/3/5 WITH HOLDER
Medpro Technologies, Inc.
FMI
Mar 17, 2000K000085PORTSETT
Portsett, Inc.
FMI
Mar 8, 2000K000657LUER ACCESS UNIVERSAL VIAL ADAPTER
Baxter Healthcare Corp
FMI
Mar 2, 2000K000387TERUMO NEEDLE WITH LOCKING SHEATH
Terumo Medical Corp.
FMI
Feb 14, 2000K992699NIPRO BLOOD COLLECTION NEEDLE
Nipro Medical Corp.
FMI
Jan 13, 2000K992729NIPRO LUER ADAPTOR
Nipro Medical Corp.
FMI
Dec 29, 1999K994197DISENTRONIC PENFINE INJECTION PEN NEEDLE
Disetronic Medical Systems
FMI
Dec 16, 1999K992626SURE-WAY REUSABLE SHARPS CONTAINER
Sure-Way Systems, Inc.
FMI
Sep 9, 1999K992091PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750
Bio-Plexus, Inc.
FMI
Aug 31, 1999K991904MODIFICATION OF JMS NEEDLES AND JMS SYRINGES
Jms Co., Ltd., JP
FMI
Jun 14, 1999K984576K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K
Terumo Europe N.V., BE
FMI
May 18, 1999K990936THE VAULT
Stik Stoppers, Inc.
FMI
May 14, 1999K991404PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)
Itl Corporation Pty, Ltd.
FMI
Apr 21, 1999K990371DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950
Post Medical, Inc.
FMI
Apr 6, 1999K982029SHARPS COLLECTION CONTAINER - SAF-T-SHELL
American Medical Mfg., Inc.
FMI
Nov 30, 1998K983750DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER
Deroyal Industries, Inc.
FMI
Nov 17, 1998K981853BONE INJECTION GUN (B.I.G.) DEVICE
Waismed, Ltd., IL
FMI
Oct 30, 1998K983067FINE-JECT
Henke Sass Wolf of America, Inc.
FMI
Oct 28, 1998K982541VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608
Becton Dickinson Vacutainer Systems
FMI
Sep 25, 1998K971924BLUNT SYRINGE CANNULA
B.Braun Medical, Inc.
FMI
Aug 6, 1998K982399DISETRONIC PENFINE INJECTION PEN NEEDLE
Disetronic Medical Systems
FMI
Jul 15, 1998K981619VACUETTE MULTIPLE SAMPLE LUER ADAPTER
Greiner Meditech, Inc.
FMI
Jul 15, 1998K972538FLOW-EZE BLUNT CANNULA (1999BC)
Acacia, Inc.
FMI
Jun 25, 1998K982097WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD
Worldwide Medical Technologies, LLC
FMI
Jun 22, 1998K981184SHARPTRACK REUSABLE SHARPS CONTAINER
Bfi- Medical Waste Systems
FMI
Jun 3, 1998K974363BECTON DICKINSON BLUNT PLASTIC CANNULA
Bd Becton Dickinson Vacutainer Systems Preanalytic
FMI
May 5, 1998K963658EXEL AVF SINGLE NEEDLE
Exel Intl.
FMI
Apr 30, 1998K972705RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC
Sage Products, Inc.
FMI
Apr 23, 1998K980227MANAN GALACTOGRAPHY KIT
Medical Device Technologies, Inc.
FMI
Apr 13, 1998K980179SHARPS PLUS 5 GALLON SHARPS CONTAINER
Rotonics Mfg., Inc.
FMI
Apr 9, 1998K980768VACUETTE HOLDEX
Greiner Meditech, Inc.
FMI
Mar 20, 1998K980062MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE
Davis & Geck, Inc.
FMI
Mar 13, 1998K980003M500-100 SHARPS CONTAINER
Imagination Medical, Inc.
FMI
Jan 22, 1998K974006BECTON DICKINSON TWINPAK
Bd Becton Dickinson Vacutainer Systems Preanalytic
FMI
Dec 17, 1997K973620VACUETTE MULTI-SAMPLE NEEDLE
Greiner Meditech, Inc.
FMI
Dec 4, 1997K973899UNIFINE PENTIPS
Owen Mumford USA, Inc.
FMI
Nov 5, 1997K973012MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM
MDC Research , Ltd.
FMI
Oct 29, 1997K9739112 GALLON ALTERNATE CARE SHARPS CONTAINER
Sage Products, Inc.
FMI
Sep 24, 1997K973339DISETRONIC PENFINE INJECTION PEN NEEDLE
Disetronic Medical Systems
FMI
Sep 4, 1997K971487BKMI DISPOSABLE SYRINGE
Sumi Salud C.A.
FMI
Aug 29, 1997K972279SHARPS SHUTTLE
Sage Products, Inc.
FMI
Aug 27, 1997K972469SELFSHIELD HN SELF SHEATHING HYPODERMIC NEEDLE
Beech Medical Products, Inc.
FMI
Aug 26, 1997K971763BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER
Retractable Technologies, Inc.
FMI
Aug 15, 1997K972536SYRINGE NEEDLE REMOVER (S.N.R.)
Post Medical, Inc.
FMI
Jul 18, 1997K970547ISOLYSER SDS SHARPS CONTAINER
Thantex Specialties, Inc.
FMI

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.