meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
35
Latest Decision
1996-04-25

Clearances · page 86 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K960620 PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM Span-America Medical Systems, Inc. FNM Class II 1996-04-25
K955464 TACTYLON POWDER FREE EXAMINATION GLOVE Tactyl Technologies, Inc. LZA Class I 1996-04-25
K954883 FREE FLOW SAFETY DEVICE Migada, Inc. FPA Class II 1996-04-23
K960993 PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) Pall Biomedical Products Co. CAK Class II 1996-04-22
K954970 STOPCOCK & LUER LOCK PLUG Medex, Inc. FMG Class II 1996-04-22
K954638 5 FR PICC-LINE CATHETER Vygon Corp. LJS Class II 1996-04-22
K933469 UNIVEC NON-REUSABLE SYRINGE Univec, Inc. MEG Class II 1996-04-18
K952435 CELSITE PEDIATRIC VENOUS SYSTEM B.Braun Medical, Inc. LJT Class II 1996-04-17
K961129 AREMA II Mellen Air Mfg., Inc. FNM Class II 1996-04-17
K960921 CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE Codan Medlon, Inc. LHI Class II 1996-04-17
K960285 MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC Medi-Ject Corp. KZE Class II 1996-04-17
K960698 NON-CORING NEEDLE Med Institute, Inc. FMI Class II 1996-04-15
K960216 CPR SUCTION CATHETER KIT Custom Pack Reliability JOL Class II 1996-04-15
K961177 CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING Carolina Narrow Fabric Co. DWL Class II 1996-04-15
K960350 THERAPORT VASCULAR ACCESS SYSTEM; MODEL 1001, 1002, 1601, 1602 Biocontrol Technology, Inc. LJT Class II 1996-04-15
K954735 ENTERALITE Zevex Intl., Inc. LZH Class II 1996-04-15
K954967 GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES Guthrie Medicare Products (Melaka) Sdn Bhd LYY Class I 1996-04-15
K960206 CPR DRESSING CHANGE TRAY Custom Pack Reliability FRG Class II 1996-04-12
K960210 CPR ORTHO HAND PACK Custom Pack Reliability FRG Class II 1996-04-12
K960213 CPR TOTAL HIP PACK Custom Pack Reliability FRG Class II 1996-04-12
K960211 CPR TOTAL KNEE PACK Custom Pack Reliability FRG Class II 1996-04-12
K960248 GENERAL PROCEDURE KIT Physician Industries, Inc. FMF Class II 1996-04-12
K960089 PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR Cottrell, Ltd. JOJ Class II 1996-04-04
K952804 TEMPERATURE PROBE-TP450 Contour Medical Technology, Inc. FMT Class II 1996-04-04
K955398 FORMULATION PREPARATION DEVICE B.Braun Medical, Inc. LHI Class II 1996-04-04
K952805 TEMPERATURE PROBE-TP550 Contour Medical Technology, Inc. FMT Class II 1996-04-04
K952801 TEMPERATURE PROBE-TP250 Contour Medical Technology, Inc. FMT Class II 1996-04-04
K960280 IVAC NEEDLE FREE VALVE ADMINISTRATION SETS Y FPA Class II 1996-04-04
K951620 MIDMARK MIDLINE CATHETER Menlo Care, Inc. FOZ Class II 1996-04-04
K952803 TEMPERATURE PROBE-TP350 Contour Medical Technology, Inc. FMT Class II 1996-04-04
K952807 TEMPERATURE PROBE-TP650 Contour Medical Technology, Inc. FMT Class II 1996-04-04
K952800 TEMPERATURE PROBE-TP150 Contour Medical Technology, Inc. FMT Class II 1996-04-04
K960212 CPR IRRIGATION TRAY Custom Pack Reliability KYZ Class I 1996-04-01
K960208 CPR BASIC SET-UP TRAY Custom Pack Reliability FRG Class II 1996-03-28
K960185 AMSINO CLINICAL THERMOMETER Amsia Intl., Inc. FLK Class II 1996-03-28
K960218 CONNECTING TUBING Custom Pack Reliability BYY Class II 1996-03-28
K960525 BEMIS ONE QUART PHLEBOTOMY CONTAINER (PART NUMBER 100) Bemis Mfg. Co. MMK Class II 1996-03-28
K960238 CPR SUTURE REMOVAL KIT Custom Pack Reliability FRG Class II 1996-03-28
K960223 CPR YANKAUER Custom Pack Reliability GCX Class II 1996-03-28
K960051 NIPRO SAFELET CATH Nissho Corp. FOZ Class II 1996-03-28
K954428 SOLOPICC 24 (60CM) 20GA CATHETER Douglas Medical Products Corp. FOZ Class II 1996-03-28
K954943 NEVOSCOPE Nizar A. Mullani KZF Class I 1996-03-27
K960012 STRYKER ADEL BASSINET Stryker Corp. FMS Class II 1996-03-25
K960224 GERATHERM MERCUIRY FREE CLINICAL THERMOMETER Rg Ent., Inc. FLK Class II 1996-03-25
K955839 MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER Baxter Edwards FOZ Class II 1996-03-25
K955874 ALTACARE Asf Industries, Inc. FNM Class II 1996-03-22
K946168 IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS Ivac Corporation LZH Class II 1996-03-21
K955819 A2 DETACHED DUAL PORT SYSTEM Arrow Intl., Inc. LJT Class II 1996-03-21
K955587 VASCULAR ACCESS PORT KIT Boston Scientific Corp LJT Class II 1996-03-21
K960520 LACERATION TRAY Medco Instruments, Inc. FRG Class II 1996-03-21
K960661 MAXCESS NEEDLE FREE CONNECTOR (8200) Solopak Medical Products, Inc. FPA Class II 1996-03-21
K953896 THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS Imed Corp. FRN Class II 1996-03-20
K955164 S.A.R.S. II (SEMI-AUTOMATIC-RECONSTITUTING-SYSTEM) Habley Medical Technology Corp. FMF Class II 1996-03-20
K960411 MICROAIR BY INVACARE MODEL APM ALTERNATING PRESSURE AIR FLOTATION MATRESS Invacare Corp. FNM Class II 1996-03-18
K954487 PRE POWDERED LATEX EXAMINATION GLOVES Ganz Industries Sdn. Bhd. LYY Class I 1996-03-15
K955748 DOYLE EXTRACTOR Safetech Intl., Inc. FMI Class II 1996-03-14
K960583 MATAR GENERAL PURPOSE DISINFECTANT Huntington Laboratories, Inc. LRJ Class I 1996-03-12
K960580 BEAUCOUP GENERAL PURPOSE DISINFECTANT Huntington Laboratories, Inc. LRJ Class I 1996-03-12
K960582 ASCEND GENERAL PURPOSE DISINFECTANT Huntington Laboratories, Inc. LRJ Class I 1996-03-12
K955426 STERITEC CROSS-CHECKS Steritec Products Mfg Co, Inc. JOJ Class II 1996-03-12
K960027 HIGH VOLUME I.V. & IRRIGATION TOWER Allen Medical Systems, Inc. FOX Class I 1996-03-12
K954415 PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM Hartalega Sdn Bhd LYY Class I 1996-03-12
K955595 SAFELINE MULTIDOSE VIAL ADAPTER Mcgaw, Inc. LHI Class II 1996-03-06
K955670 DERMATOUCH LATEX GLOVES Concordia Research Lab LYY Class I 1996-03-06
K951514 SSC MODEL 4000 SERIES Ssc Medical Products, Inc. FNL Class II 1996-03-06
K955594 SAFELINE I.V. BAG ACCESS DEVICE Mcgaw, Inc. LHI Class II 1996-03-06
K942073 SHARPSPRO-TECTOR Superior Diapering Products , Ltd. FMI Class II 1996-02-29
K951739 PUMP/BLOOD CHEMISTRY MONITOR Via Medical Corp. LZF Class II 1996-02-28
K960207 CPR LACERATION TRAY Custom Pack Reliability FRG Class II 1996-02-27
K960204 G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY GE Medical Systems FRG Class II 1996-02-27
K953825 ANGIOFLUSH II FLUID MANAGEMENT SYSTEM AngioDynamics, Inc. FPA Class II 1996-02-26
K954969 POLYFIN QR SUBCUTANEOUS INFUSION SET Medtronic Minimed FPA Class II 1996-02-22
K952995 ATI ETHYLENE OXIDE STERILIZATION INDICATOR Pymah Corp. JOJ Class II 1996-02-22
K955732 VENTED SOLUTION SET Distronic Sterile Products, Inc. FPA Class II 1996-02-21
K960201 G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY GE Medical Systems FRG Class II 1996-02-21
K960202 G.E. STERILE PUNCTURE TRAY GE Medical Systems FRG Class II 1996-02-21
K955678 RNS STERILE DISPOSABLE PUNCTURE TRAY Contour Fabricators of Florida, Inc. FRG Class II 1996-02-21
K955686 RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY Contour Fabricators of Florida, Inc. FRG Class II 1996-02-21
K955688 RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY Contour Fabricators of Florida, Inc. FRG Class II 1996-02-21
K955709 WINGED & SUBCUTANEOUS INFUSION SETS Distronic Sterile Products, Inc. FPA Class II 1996-02-21
K960141 G.E. STERILE, STANDARD BIOPSY TRAY GE Medical Systems FRG Class II 1996-02-21
K955782 MED-NET STOPCOCKS Mednet, Inc. FMG Class II 1996-02-21
K952852 NIMA (NEEDLELESS INJECTIONSITE MASTER ADAPTER) & I.V. SET Critical Device Corp. FPA Class II 1996-02-16
K950666 UNIQUE NEEDLE WITH FIRM GRIP SHIELD Unique Management Ent., Inc. FMF Class II 1996-02-16
K960013 MDC SAFE STEP SAFETY I.V. CATHETER SYSTEM MDC Research , Ltd. FOZ Class II 1996-02-13
K952044 INSULCAP Karen Holtz FMI Class II 1996-02-13
K955235 B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1996-02-12
K955515 ALPHA MICRON 20 MICROAGGREGATE FILTER Alpha Therapeutic Corp. CAK Class II 1996-02-12
K955407 PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS Sims Deltec, Inc. LJT Class II 1996-02-12
K955850 PRO-TECH Central Solutions, Inc. LRJ Class I 1996-02-09
K952967 UNIMED MEDICAL DISPENSING PUMP A.Z.E. Medical, Inc. FRN Class II 1996-02-09
K953489 DRAGER INFANT RADIANT WARMERN RH600 Drager, Inc. FMT Class II 1996-02-09
K955727 BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET I-Flow Corp. MEB Class II 1996-02-08
K950118 ABRM CATHETER Cook, Inc. FOZ Class II 1996-02-08
K955783 VLV SA.EF INFUSION PORT EXTENSION SETS Vlv Associates, Inc. FPA Class II 1996-02-07
K955399 MULTIDEX PLUS HYDROPHILIC WOUND DRESSING Lange Medical Products, Inc. KMF Class I 1996-02-07
K954593 THE AIRCEL SYSTEM Marcon Group, Inc. FNM Class II 1996-02-06
K955896 MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11 Critical Device Corp. LHI Class II 1996-02-06
K955103 3M NO STING BARRIER FILM 3M Medical Products Group KMF Class I 1996-02-05
K955357 OLYMPIC SMART SCALE MODEL 50/50RA Olympic Medical Corp. FRW Class I 1996-01-30

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