meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
37
Latest Decision
1991-08-12

Clearances · page 107 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K905415 BRAIDED HIGH PRESSURE CATHETER CONNECTOR The R Group FOZ Class II 1991-08-12
K912117 LACERATION TRAY Medical Device Inspection Co., Inc. MCY Class II 1991-08-09
K913350 VITAL-PORT(R) PETITE VASCULAR ACCESS SYSTEM Med Institute, Inc. LJT Class II 1991-08-09
K912211 INTRAVASCULAR CATHETER SECURMENT DEVICE Inman Liebelt Corp. KMK Class I 1991-08-09
K913033 LATEX EXAMINATION GLOVES Reagent Hospital Prod. , Ltd. LYY Class I 1991-08-07
K911567 DUAL COMPARTMENT TPN BAG 3 LITER Stedim, Inc. KPE Class II 1991-08-02
K912988 LATEX EXAMINATION GLOVES La Glove (M) Sdn. Bhd. LYY Class I 1991-08-02
K911964 MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM Abbott Laboratories FRN Class II 1991-08-02
K912092 MODIFIED LIFECARE MODEL 175 INFUSER Abbott Laboratories FRN Class II 1991-08-02
K911815 3RD HAND HELPER Aaron Medical Industries FPA Class II 1991-08-02
K910926 TECNADYNE SURGI-SQUEEZE INFUSION PUMP Tecnadyne Scientific, Inc. KZD Class I 1991-08-02
K912424 VITAL-PORT VASCULAR ACCESS SYSTEM 7010 AND 7110 Med Institute, Inc. LJT Class II 1991-07-30
K912465 VITAL-PORT DUAL LUMEN VASCULAR ACCESS SYSTEM 1121 Med Institute, Inc. LJT Class II 1991-07-30
K912423 VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112 Med Institute, Inc. LJT Class II 1991-07-30
K912520 3M WATER DISPERSIBLE ADHESIVE TAPE, 98XX 3M Health Care, Ltd. KGX Class I 1991-07-26
K911443 INSUL-LINE Trademark Corp. FPA Class II 1991-07-26
K911597 THE NEEDLE NABBER J. Simmons Instrument , Ltd. FMI Class II 1991-07-26
K911216 INFUSABLE Biomedical Dynamics, Inc. KZD Class I 1991-07-22
K911955 OLYMPIC WARMETTE Olympic Medical Corp. LDQ 1991-07-19
K911682 AIRSTRIP FIRST AID & POST-OP DRESSING Smith & Nephew United, Inc. KGX Class I 1991-07-17
K910936 EMPTY I.V. CONTAINER Ellis Pharmaceutical Consulting, Inc. KPE Class II 1991-07-16
K910915 PATIENT WARMER MODEL 100C Developmed Corp. FMT Class II 1991-07-16
K905713 BARD AMBULATORY PUMP TUBING SET C.R. Bard, Inc. FRN Class II 1991-07-15
K905778 EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT Baxter Healthcare Corp FRN Class II 1991-07-12
K911576 CHEMOTHERAPY CONTAINER Bemis Mfg. Co. KPE Class II 1991-07-05
K911070 PICC-FIX Sorex Medical KMK Class I 1991-07-05
K912042 BETHEL PLUS MULTIPLE NAMES Bethel Latex Products, Inc. LZB Class I 1991-07-02
K911586 GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) Megadyne Medical Products, Inc. BYY Class II 1991-07-02
K911436 SHARPS PIN CUSHION(TM) CONTAINER Catalyst, Inc. FMI Class II 1991-07-01
K910657 QUALTEX ISLAND DRESSING Deroyal Industries, Inc. KGX Class I 1991-07-01
K912083 LATEX PATIENT EXAMINATION GLOVES, HYPOALLERGENIC Sterigard, Inc. LYY Class I 1991-06-27
K911753 INTERVASCULAR ADMINSTRATION SET Mcgaw, Inc. FPA Class II 1991-06-24
K911868 INTERLINK(TM) BLUNT CANNULA, MODIFICATION Baxter Healthcare Corp FPA Class II 1991-06-24
K910934 FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM Baxter Healthcare Corp FRN Class II 1991-06-24
K912458 MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED Medtronic Minimed FRN Class II 1991-06-24
K911760 MONARCH STERILIZATION CONTAINER SYST, MODIFICATION Monarch Products, Inc. FRG Class II 1991-06-24
K904890 BARD ALFENTANIL INFUSER C.R. Bard, Inc. FRN Class II 1991-06-24
K911449 VITAL-PORT VASCULAR ACCESS SYSTEM Med Institute, Inc. LJT Class II 1991-06-24
K910963 THOROCENTESIS KIT Megadyne Medical Products, Inc. JOL Class II 1991-06-20
K910089 MEGA LUMBAR PUNCTURE KIT Megadyne Medical Products, Inc. FMJ Class II 1991-06-20
K911931 LUER LOCK INJECTION CAP Dmd Products FPA Class II 1991-06-18
K912031 AVI MODEL 870 DUAL CHANNEL INFUSION PUMP 3M Avi, Inc. FRN Class II 1991-06-18
K911136 B-D SAFETY-LOK(TM) I.V. NEEDLES Bd Becton Dickinson Vacutainer Systems Preanalytic FPA Class II 1991-06-14
K911765 HAND CARRIED STRETCHER L.E. Phillips Career Development Center, Inc. FPP Class I 1991-06-14
K905794 PALL 3N1 FILTER Pall Biomedical Products Co. FPB Class II 1991-06-13
K911791 CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP Pharmacia Deltec, Inc. MEA Class II 1991-06-11
K911607 GESCO UMBILI-CATH Gesco Intl., Inc. FOS Class II 1991-06-11
K911451 I.V. EXTENDER SET Filtertek, Inc. FPB Class II 1991-06-06
K895920 VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS Vitaphore Corp. KGX Class I 1991-06-06
K910733 MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE Medisystems Corp. FMI Class II 1991-06-06
K910880 COMFOR-BOARD Medway KMK Class I 1991-06-06
K902422 NEEDLE, ASPIRATION & INJECTION, DISPOSABLE Gainor Medical Europe, Ltd. FMI Class II 1991-06-06
K905219 4' LOW VOLUME IV EXTENSION SET Marquette Medical, Inc. FPA Class II 1991-06-04
K905218 4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP Marquette Medical, Inc. FPA Class II 1991-06-04
K910565 VERSACATH(TM) SELECTALUMEN(TM) W/CONVERSION TRAY Menlo Care, Inc. FOZ Class II 1991-06-03
K910566 VERSACATH(TM) MULTILUMEN SYSTEM Menlo Care, Inc. FOZ Class II 1991-06-03
K911067 NORCATH VASCULAR ACCESS CATHETERS Norfolk Medical LJS Class II 1991-06-03
K911415 TRUMPET VALVE B. Braun of America, Inc. FMG Class II 1991-06-03
K911769 RATEMINDER(TM) V INFUSION PUMP, MODIFICATION Critikon Company, LLC FRN Class II 1991-06-03
K910927 SPENCIO SKIN GUARD KIT Spenco Medical Corp. KMF Class I 1991-06-03
K912038 DASH MEDICAL GLOVES Safehealth Labs LYY Class I 1991-06-03
K910024 VOLUMETRIC INFUSION PUMP Baxter Healthcare Corp FRN Class II 1991-05-31
K911077 JAIN SUTURE PACKAGE COUNTER Jain Surgical Equipment, Inc. MMK Class II 1991-05-31
K905374 IV EXTENSION SETS WITH .22 MICRON FILTER Marquette Medical, Inc. FPA Class II 1991-05-31
K910844 INFUSION PUMP Technology Transfer Intl., Inc. FRN Class II 1991-05-31
K911076 JAIN QUICK COUNT Jain Surgical Equipment, Inc. MMK Class II 1991-05-30
K910350 MICREL LTD-PORTABLE INFUSION PUMP-MP20Q Technology Transfer Intl., Inc. FRN Class II 1991-05-30
K910758 MICREL LTD - PORTABLE INFUSION MICROPUMP-MP11 Technology Transfer Intl., Inc. FRN Class II 1991-05-30
K905439 HYPERGEL PROTECTIVE WOUND GEL Scott Health Care KMF Class I 1991-05-29
K911948 MEDI GUARD PILLOWCASE Sancella, Inc. KME Class I 1991-05-28
K911401 ABBOTT LIFECARE 5000 PUMP Abbott Laboratories FRN Class II 1991-05-28
K911953 MEDI GUARD SHEETS/UNDERLAYS Sancella, Inc. KME Class I 1991-05-28
K911952 MEDI GUARD UNDERPAD Sancella, Inc. KME Class I 1991-05-28
K910919 ABBOTT LIFECARE 5000 PUMP MODIFIED Abbott Laboratories FRN Class II 1991-05-23
K911950 MEDI GUARD DRAPES Sancella, Inc. KME Class I 1991-05-21
K911289 EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP Baxter Healthcare Corp FRN Class II 1991-05-21
K905413 JUZO-RESPIRA ANTI-EMBOLISM STOCKING Julius Zorn, Inc. DWL Class II 1991-05-17
K910949 LATEX EXAM GLOVES-POWDER FREE Zhongmin (Fujian) Machinery & Electrical Equipment LYY Class I 1991-05-17
K911269 MERCURY AND GLASS FEVER THERMOMETER Steridyne Corp. FLK Class II 1991-05-15
K910142 SPARK KIT(R), MODIFICATION Lyphomed, Inc. FPA Class II 1991-05-14
K910637 MENTOR(R) SUR-E-TROL(R) Mentor O & O, Inc. FRN Class II 1991-05-13
K911633 PERRY(R) ENCORE CHEMOTHERAPY GLOVE Smith & Nephew Perry LYY Class I 1991-05-09
K902853 GRAVITY PLUS CONTROLLER/COMPOUNDER Fergy Corp. LHI Class II 1991-05-09
K904237 RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM Innovative Medical Technologies, Inc. FPP Class I 1991-05-09
K910678 TRO-GARD Conmedcorp KGX Class I 1991-05-08
K910731 DISPOSABLE RETRACTABLE NEEDLE SYRINGE Safe Tech Medical Products, Inc. FMF Class II 1991-05-07
K910564 VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY Menlo Care, Inc. FOZ Class II 1991-05-06
K910790 MENTOR LUBRICATING JELLY Mentor Corp. KMJ Class I 1991-05-03
K911037 SAFETY NEEDLE SHEATH, MODIFICATION Concord/Portex FMI Class II 1991-05-03
K910241 STATIM CASSETTE AUTOCLAVE Scican FLE Class II 1991-05-03
K911774 ALADAN LATEX MEDICAL GLOVE Aladan Corp. LYY Class I 1991-05-03
K910320 SERIM PERACETIC ACID REAGENT STRIPS Serim Research Corp. JOJ Class II 1991-05-01
K910572 INJECTION CAPS Akcess Medical Products, Inc. FOZ Class II 1991-04-29
K910516 DISPOSAL PAD FOR SHARPS Visitec Co. MMK Class II 1991-04-29
K910546 PIGGY LOCK NEEDLE HOUSING Icu Medical, Inc. FPA Class II 1991-04-29
K904955 CONSUMER SENSORY PRODUCTS BIO-LOG 8000 Consumer Sensory Products, Inc. FLL Class II 1991-04-25
K910879 PLASTIC (VINYL) EXAMINATION GLOVES Siamount Plastic Corporation , Ltd. LYZ Class I 1991-04-25
K905173 SPLASH GUARD E.M. Adams KYZ Class I 1991-04-25
K911694 PATIENT EXAMINATION LATEX GLOVES (NON-STERILE) Guthrie Medicare Products (Melaka) Sdn Bhd LYY Class I 1991-04-25
K905116 PHARM-ASSIST Excel Medical, Inc. LHI Class II 1991-04-25

15,723 clearances in the General Hospital panel. Data: openFDA.