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

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
Mar 19, 1984K834407STERILE DISPOSABLE SPINAL NEEDLES
Hydro-Med Products, Inc.
FMI
Mar 15, 1984K834436CHEMONUCLEOLYSIS NEEDLE
Universal Medical Instrument Corp.
FMI
Mar 6, 1984K834553INTRADISCAL THERAPY TRAY
Bd Becton Dickinson Vacutainer Systems Preanalytic
FMI
Oct 27, 1983K830568GUTTMAN INFUSION NEEDLE
Cosmetic Sciences, Inc.
FMI
Sep 29, 1983K832858INTRADISCAL THERAPY TRAY
Ulti-Med Intl., Inc.
FMI
Sep 12, 1983K832556NEONATAL LUMBAR PUNCTURE TRAY
American Pharmaseal Div. Ahsc
FMI
Sep 1, 1983K832102STERILE DISPOSABLE NEEDLES
Lee Medical Intl., Inc.
FMI
Aug 24, 1983K831063BUTTON INFUSER
Markwell Medical Institute, Inc.
FMI
Jul 26, 1983K831395AVL 0073 MICROSAMPLER
Avl Scientific Corp.
FMI
Jul 12, 1983K831765HERAPIN LOCK FLUSH SOLUTION USE KIT
Smith & Nephew, Mpl Division
FMI
Jul 12, 1983K831610INTRADISCAL THERAPY NEEDLE
Bd Becton Dickinson Vacutainer Systems Preanalytic
FMI
Apr 14, 1983K823899INFANT CARE SYSTEM
Narco Scientific
FMI
Feb 15, 1983K830242MICRO 2 HYPODERMIC NEEDLES
Smith & Nephew, Mpl Division
FMI
Feb 7, 1983K823693MYELOGRAPHY NEEDLE
Ocean Medical Products, Ltd.
FMI
Jan 26, 1983K823696MICRO Z BLOOD COLLECTING NEEDLES
Hospital Products Co.
FMI
Nov 22, 1982K823255NON-STERILE REUSABLE NEEDLES
Vertex Medical Corp.
FMI
Jun 9, 1982K821529DISPOSABLE HYPODERMIC NEEDLES
Medcare Disp Products, Inc.
FMI
Apr 15, 1982K820911PBC NEEDLE BY NIPRO MED. INDUSTRIES
Philadelphia Biologics Center
FMI
Mar 25, 1982K813256HYPODERMIC & SUTURE NEEDLES
Needle Industries(Usa), Inc.
FMI
Jan 28, 1982K813649PBC NEEDLE
Philadelphia Biologics Center
FMI
Jan 28, 1982K813648JMS NEEDLE & MAC JECT
Philadelphia Biologics Center
FMI
Jan 12, 1982K813545HYPOSERMIC NEEDLES
Optical Micro Systems, Inc.
FMI
Nov 6, 1981K812910MEDISYSTEMS NEEDLES & SYRINGES
Medisystems Corp.
FMI
Sep 9, 1981K812404BUTTERFLY NEEDLE ASSEMBLY
Nu Tech Medical Systems
FMI
Jul 23, 1981K811966VISITEC NEEDLE RANGE (GENERAL HOSPITAL)
Visitec Co.
FMI
Sep 16, 1980K801839DISPOSABLE HYPODERMIC NEEDLES
Martin'S Maine Exchange
FMI
Aug 12, 1980K801431PAN-AM MYELOGRAM TRAY
Waters Assoc., Inc.
FMI
May 30, 1980K801108DOUBLE ENDED VENTED TRANSFER DEVICE
Burron Medical Products, Inc.
FMI
May 30, 1980K801107DOUBLE ENDED FILTERED TRANSFER NEEDLE
Burron Medical Products, Inc.
FMI
Nov 16, 1979K7920962 FR KELMAN CHAMBER MAINTAINER
Heyer Schulte Corp.
FMI
Sep 24, 1979K791462HYPERDERMIC NEEDLE WITH SENSOR #514
Medtech Intl., Inc.
FMI
Jul 30, 1979K791156AMIPAQUE MYELOGRAM TRAY
Pharmaseal Div., Baxter Healthcare Corp.
FMI
Jun 27, 1979K790953BORDISPO BRAND HYPODERMIC NEEDLE
Borda Products, Inc.
FMI
Feb 8, 1979K790086NEEDLE, TRUCARE VACUTAINER
Bd Becton Dickinson Vacutainer Systems Preanalytic
FMI
Apr 10, 1978K780209DILUTION SPIKE
Sterling Drug, Inc.
FMI
Oct 13, 1977K771667BLOOD GAS TRAY #4024
Concord Laboratories, Inc.
FMI
Jul 26, 1977K771209TERUFUSION BLOOD ADMIN. SET
Terumo America, Inc.
FMI
Jul 14, 1977K771207TERUFUSION DONOR SET
Terumo America, Inc.
FMI
Jul 14, 1977K771203DISP. HYPODERMIC NEEDLE
Terumo America, Inc.
FMI
Apr 29, 1977K770528NEEDLE, MEMBRANE
American Viggo
FMI
Apr 15, 1977K770425NEEDLES, STERILE, AIRWAY
Pfizer Pharmaceuticals
FMI
Mar 16, 1977K770370CONVENIENCE TRAY
Johannah Medical Services, Inc.
FMI
Jan 28, 1977K761098FILTER DEVICES
Arrow Intl., Inc.
FMI
Nov 16, 1976K760780DOUBLE-ENDED NEEDLE
Travenol Laboratories, S.A.
FMI

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