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

Syringe, Piston

Regulation 880.5860

13510(k)s in 12 months (752 all time)
4recalls in 12 months (305 all time)
168recalls that name a 510(k)
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Top companies in FMF

Decided510(k)Device and applicantCode
Feb 26, 1998K972900ULTRASAFE MODEL T200 INJECTOR
Safety Syringes, Inc.
FMF
Feb 26, 1998K972877ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD
Safety Syringes, Inc.
FMF
Dec 22, 1997K970419DAXOR MAX100 SYRINGE (MAX100)
Daxor Corporation
FMF
Dec 8, 1997K973510DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML)
Immuno-U.S., Inc.
FMF
Oct 30, 1997K972878ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300
Safety Syringes, Inc.
FMF
Sep 8, 1997K964597BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE
Biosurgical Corp.
FMF
Jul 25, 1997K971664RAMY PISTON SYRINGE
Alshifa Medical Syringes Mfg. Co., Ltd.
FMF
Jul 24, 1997K972452RAMY INTEGRATED NEEDLE SYRINGE
Alshifa Medical Syringes Mfg. Co., Ltd.
FMF
Jul 24, 1997K964230CORELIFE
Core Healthcare , Ltd.
FMF
Mar 4, 1997K965030BRANNON ARTERIO-VENOUS PORTSYRINGE
Vascular Logics, Inc.
FMF
Feb 10, 1997K962084OMNICAN SYRINGE
B. Braun Medical AG
FMF
Dec 24, 1996K964060COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE
Travenol Laboratories (Israel) , Ltd., IL
FMF
Dec 19, 1996K945410IRT LOCKING SYRINGE
Interventional Research Technologies
FMF
Nov 22, 1996K963260DRESSING CHANGE TRAYS
Busse Hospital Disposables, Inc.
FMF
Oct 8, 1996K962042GLASS SYRINGE
Ispg, Inc.
FMF
Sep 12, 1996K962329GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10
Global Medical Prods, Inc.
FMF
Sep 6, 1996K962614SHIFA STERILE DISPOSABLE SYRINGES
International Regulatory Consultants
FMF
Jul 25, 1996K955606PISTON SYRINGE
Medical Surgical Intl.
FMF
Jul 8, 1996K960882CONTROL SYRINGE
Louisville Laboratories, Inc.
FMF
May 24, 1996K960049BRANNON PORTSYRINGE
James K. Brannon
FMF
May 24, 1996K960047BRANNON PEDI PORTSYRINGE
James K. Brannon
FMF
May 21, 1996K953940TERUMO RETRACTABLE NEEDLE (RN) SYRINGE
Terumo Medical Corp.
FMF
May 6, 1996K955282THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS
Thermogenesis Corp.
FMF
Apr 12, 1996K960248GENERAL PROCEDURE KIT
Physician Industries, Inc.
FMF
Mar 20, 1996K955164S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM)
Habley Medical Technology Corp.
FMF
Feb 16, 1996K950666UNIQUE NEEDLE WITH FIRM GRIP SHIELD
Unique Management Ent., Inc.
FMF
Dec 6, 1995K950245UNIQUE NEEDLE
Unique Management Ent., Inc.
FMF
Dec 1, 1995K953626SYRINGE MAGNIFIER
Innovative Premiums, Inc.
FMF
Nov 29, 1995K950969DISPOSABLE SYRINGE
Surgiplast , Ltd., IN
FMF
Nov 21, 1995K954064BECTON DICKINSON SYRINGSE
Bd Becton Dickinson Vacutainer Systems Preanalytic
FMF
Nov 13, 1995K954337GENOTROPIN MIXER
Pharmacia, Inc.
FMF
Oct 24, 1995K951919B-D PEN ULTRA
Bd Becton Dickinson Vacutainer Systems Preanalytic
FMF
Oct 19, 1995K954189EASI-JECTOR CONTROL SYSTEM
North, Inc.
FMF
Oct 19, 1995K951025PISTON SYRINGE
Pharmacia, Inc.
FMF
Oct 4, 1995K952201PORT-A-CATH ACCESS KIT
Medi-Flex Hospital Products, Inc.
FMF
Oct 3, 1995K952553ALPHA MEDICA DISPOSABLE, STERILE, NONPYROGENIC SYRINGE
Alpha Medica
FMF
Sep 29, 1995K944542REUSABLE ALL - GLASS SYRINGES
Top Syringe Mfg. Co., IN
FMF
Sep 22, 1995K951980COLLAPSIBLE HYPODERMIC SYRINGE
Roman Vladimirsky
FMF
Sep 15, 1995K952918PTFE SYRINGE FILTER
B.Braun Medical, Inc.
FMF
Aug 25, 1995K950824STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS
Stryker Corp.
FMF
Jul 20, 1995K951918SURGICAL TECHNOLOGIES, INC. SYRINGE
Surgical Technologies, Inc.
FMF
Jul 14, 1995K945592VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE
Vlv Associates, Inc.
FMF
Jun 21, 1995K951871PISTON SYRINGE
Baxa Corp.
FMF
Jun 6, 1995K951619UNIVEC NONREUSABLE LOCKING SYRINGE
Univec, Inc.
FMF
May 19, 1995K945797STERILE EMPTY PCA SYRINGE
Intl. Medication Systems, Ltd.
FMF
Apr 26, 1995K942159NOVOPEN 1.5
Novo Nordisk Pharmaceuticals, Inc.
FMF
Apr 13, 1995K950133HYPODERMIC SYRINGE PISTON
Ispg, Inc.
FMF
Mar 17, 1995K946190DRUG DISPENSING SPIKE
Gelman Sciences, Inc.
FMF
Mar 1, 1995K945715MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES
Sherwood Medical Co.
FMF
Feb 10, 1995K945588DISPOSABLE 1CC SYRINGE WITH LUER LOCK
Interventional Therapeutics Corp.
FMF

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