FDA Product Code
FDA Product Code FMF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5860
510(k) Clearances — 752 records · page 5 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K972900 | ULTRASAFE MODEL T200 INJECTOR | Safety Syringes, Inc. | 1998-02-26 | Traditional | PDF ↗ |
| K972877 | ULTRASAFE INJECTION SYSTEM MODEL C200 INJECTOR WITH NEEDLE GUARD | Safety Syringes, Inc. | 1998-02-26 | Traditional | PDF ↗ |
| K970419 | DAXOR MAX100 SYRINGE (MAX100) | Daxor Corporation | 1997-12-22 | Traditional | PDF ↗ |
| K973510 | DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML) | Immuno-U.S., Inc. | 1997-12-08 | Traditional | PDF ↗ |
| K972878 | ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300 | Safety Syringes, Inc. | 1997-10-30 | Traditional | PDF ↗ |
| K964597 | BIOSURGICAL, CORP. MULTI CHAMBER SUCTION SYRINGE | Biosurgical Corp. | 1997-09-08 | Traditional | PDF ↗ |
| K971664 | RAMY PISTON SYRINGE | Alshifa Medical Syringes Mfg. Co., Ltd. | 1997-07-25 | Traditional | PDF ↗ |
| K964230 | CORELIFE | Core Healthcare , Ltd. | 1997-07-24 | Traditional | PDF ↗ |
| K972452 | RAMY INTEGRATED NEEDLE SYRINGE | Alshifa Medical Syringes Mfg. Co., Ltd. | 1997-07-24 | Traditional | PDF ↗ |
| K965030 | BRANNON ARTERIO-VENOUS PORTSYRINGE | Vascular Logics, Inc. | 1997-03-04 | Traditional | PDF ↗ |
| K962084 | OMNICAN SYRINGE | B. Braun Medical AG | 1997-02-10 | Traditional | PDF ↗ |
| K964060 | COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE | Travenol Laboratories (Israel) , Ltd. | 1996-12-24 | Traditional | PDF ↗ |
| K945410 | IRT LOCKING SYRINGE | Interventional Research Technologies | 1996-12-19 | Traditional | PDF ↗ |
| K963260 | DRESSING CHANGE TRAYS | Busse Hospital Disposables, Inc. | 1996-11-22 | Traditional | PDF ↗ |
| K962042 | GLASS SYRINGE | Ispg, Inc. | 1996-10-08 | Traditional | PDF ↗ |
| K962329 | GLOBAL LOSS OF RESISTANCE SYRINGE GLOR 10 | Global Medical Prods, Inc. | 1996-09-12 | Traditional | PDF ↗ |
| K962614 | SHIFA STERILE DISPOSABLE SYRINGES | International Regulatory Consultants | 1996-09-06 | Traditional | PDF ↗ |
| K955606 | PISTON SYRINGE | Medical Surgical Intl. | 1996-07-25 | Traditional | PDF ↗ |
| K960882 | CONTROL SYRINGE | Louisville Laboratories, Inc. | 1996-07-08 | Traditional | PDF ↗ |
| K960047 | BRANNON PEDI PORTSYRINGE | James K. Brannon | 1996-05-24 | Traditional | PDF ↗ |
| K960049 | BRANNON PORTSYRINGE | James K. Brannon | 1996-05-24 | Traditional | PDF ↗ |
| K953940 | TERUMO RETRACTABLE NEEDLE (RN) SYRINGE | Terumo Medical Corp. | 1996-05-21 | Traditional | PDF ↗ |
| K955282 | THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS | Thermogenesis Corp. | 1996-05-06 | Traditional | PDF ↗ |
| K960248 | GENERAL PROCEDURE KIT | Physician Industries, Inc. | 1996-04-12 | Traditional | PDF ↗ |
| K955164 | S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM) | Habley Medical Technology Corp. | 1996-03-20 | Traditional | PDF ↗ |
| K950666 | UNIQUE NEEDLE WITH FIRM GRIP SHIELD | Unique Management Ent., Inc. | 1996-02-16 | Traditional | PDF ↗ |
| K950245 | UNIQUE NEEDLE | Unique Management Ent., Inc. | 1995-12-06 | Traditional | PDF ↗ |
| K953626 | SYRINGE MAGNIFIER | Innovative Premiums, Inc. | 1995-12-01 | Traditional | PDF ↗ |
| K950969 | DISPOSABLE SYRINGE | Surgiplast , Ltd. | 1995-11-29 | Traditional | PDF ↗ |
| K954064 | BECTON DICKINSON SYRINGSE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-11-21 | Traditional | PDF ↗ |
| K954337 | GENOTROPIN MIXER | Pharmacia, Inc. | 1995-11-13 | Traditional | PDF ↗ |
| K951919 | B-D PEN ULTRA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-10-24 | Traditional | PDF ↗ |
| K951025 | PISTON SYRINGE | Pharmacia, Inc. | 1995-10-19 | Traditional | PDF ↗ |
| K954189 | EASI-JECTOR CONTROL SYSTEM | North, Inc. | 1995-10-19 | Traditional | PDF ↗ |
| K952201 | PORT-A-CATH ACCESS KIT | Medi-Flex Hospital Products, Inc. | 1995-10-04 | Traditional | PDF ↗ |
| K952553 | ALPHA MEDICA DISPOSABLE, STERILE, NONPYROGENIC SYRINGE | Alpha Medica | 1995-10-03 | Traditional | PDF ↗ |
| K944542 | REUSABLE ALL - GLASS SYRINGES | Top Syringe Mfg. Co. | 1995-09-29 | Traditional | PDF ↗ |
| K951980 | COLLAPSIBLE HYPODERMIC SYRINGE | Roman Vladimirsky | 1995-09-22 | Traditional | PDF ↗ |
| K952918 | PTFE SYRINGE FILTER | B.Braun Medical, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K950824 | STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS | Stryker Corp. | 1995-08-25 | Traditional | PDF ↗ |
| K951918 | SURGICAL TECHNOLOGIES, INC. SYRINGE | Surgical Technologies, Inc. | 1995-07-20 | Traditional | PDF ↗ |
| K945592 | VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE | Vlv Associates, Inc. | 1995-07-14 | Traditional | PDF ↗ |
| K951871 | PISTON SYRINGE | Baxa Corp. | 1995-06-21 | Traditional | PDF ↗ |
| K951619 | UNIVEC NONREUSABLE LOCKING SYRINGE | Univec, Inc. | 1995-06-06 | Traditional | PDF ↗ |
| K945797 | STERILE EMPTY PCA SYRINGE | Intl. Medication Systems, Ltd. | 1995-05-19 | Traditional | PDF ↗ |
| K942159 | NOVOPEN 1.5 | Novo Nordisk Pharmaceuticals, Inc. | 1995-04-26 | Traditional | PDF ↗ |
| K950133 | HYPODERMIC SYRINGE PISTON | Ispg, Inc. | 1995-04-13 | Traditional | PDF ↗ |
| K946190 | DRUG DISPENSING SPIKE | Gelman Sciences, Inc. | 1995-03-17 | Traditional | PDF ↗ |
| K945715 | MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES | Sherwood Medical Co. | 1995-03-01 | Traditional | PDF ↗ |
| K945588 | DISPOSABLE 1CC SYRINGE WITH LUER LOCK | Interventional Therapeutics Corp. | 1995-02-10 | Traditional | PDF ↗ |
| K940635 | SAFE-1(TM) SYRINGE | Safety 1st Medical, Inc. | 1995-01-31 | Traditional | PDF ↗ |
| K942394 | SAFE VENT SYSTEM | Incutech, Inc. | 1995-01-27 | Traditional | PDF ↗ |
| K945225 | DISPOSABLE SYRINGES AND DISPOSABLE NEEDLES | Myco Medical Supplies, Inc. | 1995-01-26 | Traditional | PDF ↗ |
| K944920 | CG DISPOSABLE SYRINGE | Fortunique Medical Products | 1994-12-20 | Traditional | PDF ↗ |
| K936015 | DISPOSABLE DISC FILTER | Medi-Dose, Inc. | 1994-12-12 | Traditional | PDF ↗ |
| K944355 | NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES | Nissho Corp. | 1994-12-07 | Traditional | PDF ↗ |
| K941589 | SYRINGE FILTER DEVICES | Gelman Sciences, Inc. | 1994-09-06 | Traditional | PDF ↗ |
| K941020 | DRUG RECONSTITUTION FILTER DEVICE | Gelman Sciences, Inc. | 1994-08-10 | Traditional | PDF ↗ |
| K942221 | IRRIGATION TRAY WITH PISTON SYRINGE | Trinity Laboratories, Inc. | 1994-08-05 | Traditional | PDF ↗ |
| K942615 | SYRINGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-07-21 | Traditional | PDF ↗ |
| K941095 | MEDSAVER SYRINGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-06-17 | Traditional | PDF ↗ |
| K935092 | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM | Contour Fabricators of Florida, Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K941032 | UNKNOWN | Gelman Sciences, Inc. | 1994-05-27 | Traditional | PDF ↗ |
| K941562 | 1ML LUER-LOK SYRINGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-05-26 | Traditional | PDF ↗ |
| K941657 | BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-05-26 | Traditional | PDF ↗ |
| K941545 | ADVANTAGE SYRINGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-05-23 | Traditional | PDF ↗ |
| K925822 | CUSTOM SYRIGENE KITS | Syrigene Medical Technologies, Inc. | 1994-04-22 | Traditional | PDF ↗ |
| K933335 | RIVER VIAL ADAPTER | River Medical, Inc. | 1994-03-01 | Traditional | PDF ↗ |
| K931472 | CAREJECT DISPOSABLE SYRINGE AND NEEDLE | Carewell Mediproducts, Ltd. | 1994-02-22 | Traditional | PDF ↗ |
| K934561 | ONE TIME VIAL ACCESS SPIKE | Icu Medical, Inc. | 1994-02-10 | Traditional | PDF ↗ |
| K920039 | MEDIJECT DISPOSABLE SYRINGES | P.T. Igar Jaya | 1994-02-09 | Traditional | PDF ↗ |
| K932001 | ALLISON MEDICAL SYRINGE | Allison Medical, Inc. | 1994-01-21 | Traditional | PDF ↗ |
| K932361 | BASIC SKIN PREP TRAY | Mcbar Industries | 1993-12-13 | Traditional | PDF ↗ |
| K923321 | EDGE SYRINGES AND NEEDLES | Trico Intl., Inc. | 1993-09-28 | Traditional | PDF ↗ |
| K931095 | SPRING LOADED SYRINGE | Acacia, Inc. | 1993-09-16 | Traditional | PDF ↗ |
| K931632 | I.D.A. SYRINGES | Pt Hasoon Chandra | 1993-08-24 | Traditional | PDF ↗ |
| K930791 | AMERICAN POWER CONVERSIONS, BACK-UPS 600 | Bio Clinic Co. | 1993-08-06 | Traditional | PDF ↗ |
| K924511 | MONOJECT(R) 6 CC SAFETY SYRINGE | Sherwood Medical Co. | 1993-07-29 | Traditional | PDF ↗ |
| K925548 | FIBRACOL COLLAGEN-ALGINATE DRESSING | Johnson & Johnson Medical, Inc. | 1993-07-13 | Traditional | PDF ↗ |
| K923183 | GENESIS SPRAY TIP ATOMIZER | Mai | 1993-07-13 | Traditional | PDF ↗ |
| K930847 | ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY | Sherwood Medical Co. | 1993-07-12 | Traditional | PDF ↗ |
| K921908 | NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY DEVICE | Novo Nordisk Pharmaceuticals, Inc. | 1993-06-29 | Traditional | PDF ↗ |
| K930321 | BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD. | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-05-17 | Traditional | PDF ↗ |
| K930342 | BECTON DICKINSON ARTERIAL BLOOD GAS KITS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-04-07 | Traditional | PDF ↗ |
| K926007 | ACCESSORY TO PISTON SYRINGE | Martech Medical Products, Inc. | 1993-02-23 | Traditional | PDF ↗ |
| K915780 | RACK AND SYRINGES | Normeca Corp. | 1993-01-27 | Traditional | PDF ↗ |
| K924072 | BECTON DICKINSON SAFETY-LOK SYRINGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-12-17 | Traditional | PDF ↗ |
| K922522 | MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES | Sherwood Medical Co. | 1992-11-25 | Traditional | PDF ↗ |
| K922041 | PRIMARY SURGICAL DRESSING TRAY | Transidyne General Corp. | 1992-11-06 | Traditional | PDF ↗ |
| K922190 | LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | Advanced Surgical, Inc. | 1992-10-23 | Traditional | PDF ↗ |
| K923645 | VISITEC ASPIRATING SYRINGE | Visitec Co. | 1992-09-30 | Traditional | PDF ↗ |
| K921833 | ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD | ETHICON, Inc. | 1992-09-21 | Traditional | PDF ↗ |
| K915676 | SPLATTER SHIELD | Chathamborough Research Group, Inc. | 1992-09-11 | Traditional | PDF ↗ |
| K912437 | IRRIGATING SYRINGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-07-13 | Traditional | PDF ↗ |
| K920422 | B-D INTERLINK SYRINGE CANNULA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-04-29 | Traditional | PDF ↗ |
| K920321 | BECTON DICKINSON SAFETY-LOK SYRINGE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-04-20 | Traditional | PDF ↗ |
| K920398 | CEPTI-SEAL DRESSING CHNG. KIT FOR CENT. VENOUS CAT | Medi-Flex Hospital Products, Inc. | 1992-04-15 | Traditional | PDF ↗ |
| K913541 | NEO-THOR THORACOSTOMY KIT | Intl. Medical Devices , Ltd. | 1992-04-09 | Traditional | PDF ↗ |
| K913540 | PEDIA-THOR THORACOSTOMY KIT | Intl. Medical Devices , Ltd. | 1992-04-09 | Traditional | PDF ↗ |
| K913114 | TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT | Gerard Medical Enterprises, Inc. | 1992-01-02 | Traditional | PDF ↗ |
Product code FMF · Class II · General Hospital. Data: openFDA.