meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
43
Latest Decision
1984-03-23

Clearances · page 141 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K840924 SYRINGE, PISTON, ARTERIAL BLOOD SAMPL Medcare Disp Products, Inc. FMF Class II 1984-03-23
K840894 PHOTO-THERAPY EYE PROTECTOR A & A Medical Supplies Co. FOK Class I 1984-03-23
K840967 OHIO HEAT REFLECTING PATCH Ohio Medical Products FMI Class II 1984-03-23
K840858 OHIO 3300 INFANT WARMER SYSTEM Ohio Medical Products FMT Class II 1984-03-23
K840454 PHOTOTHERAPY UNIT 7850 NEONATAL PHOTO Air-Shields, Inc. LBI Class II 1984-03-23
K840857 OHIO 3000 INFANT WARMER SYSTEM Ohio Medical Products FMT Class II 1984-03-23
K840644 FLO-GARD 4000 VOLUMETRIC INFUSION Travenol Laboratories, S.A. LDR Class II 1984-03-23
K840116 DESERET INFANT CENTRAL VENOUS CATHE- Parke-Davis Co. FOZ Class II 1984-03-22
K840411 BLOOD & PLASMA ADMIN. DEV-STERILE Loversan BRZ Class II 1984-03-19
K840183 DESERET MULTILUMEN SUBCLAVIAN JUGULAR Parke-Davis Co. FOZ Class II 1984-03-19
K834407 STERILE DISPOSABLE SPINAL NEEDLES Hydro-Med Products, Inc. FMI Class II 1984-03-19
K840410 SOLUTION ADMIN. SET STERILE Loversan FPA Class II 1984-03-19
K840409 INFUSION SET-STERILE Loversan FPA Class II 1984-03-19
K840920 KEYMED MOBILE ENDOSCOPY PATIENT COUCH Keymed, Inc. FPO Class II 1984-03-19
K834227 DESERET SUBCLAVIAN JUGULAR CATH. SET Parke-Davis Co. FOZ Class II 1984-03-19
K840394 STOPCOCKS & EXTENSION TUBES American Pharmaseal Div. Ahsc FMG Class II 1984-03-19
K840355 DESERET MULTILUMEN SUBCLAVIAN JUGULAR Parke-Davis Co. FOZ Class II 1984-03-19
K834152 ETHYLENE OXIDE DETECTOR GLD-1-07 Calnor of EL Paseo, Inc. FLE Class II 1984-03-19
K840862 DESERET CENTRAL VENOUS CATHETER Parke-Davis Co. FOZ Class II 1984-03-19
K834353 OK FLASH STERILIZATION INDICATOR Propper Mfg. Co., Inc. JOJ Class II 1984-03-19
K840653 BERNIER ARM SUPPORT T.C. Toll Corp. FNJ Class I 1984-03-19
K840595 E-Z OPEN DUST COVERS Plasti-Products, Inc. FRG Class II 1984-03-19
K833954 MELOLITE Smith & Nephew, Inc. KGX Class I 1984-03-19
K833442 PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM Quinton, Inc. LJS Class II 1984-03-19
K834436 CHEMONUCLEOLYSIS NEEDLE Universal Medical Instrument Corp. FMI Class II 1984-03-15
K834255 PBC SCALP VEIN SET Philadelphia Biologics Center FOZ Class II 1984-03-12
K833916 HYPAFIX DRESSING RETENTION SHEET Smith & Nephew, Inc. KGX Class I 1984-03-12
K840212 CONCENTRATED PLATELET ADMIN. SET American Mcgaw FPA Class II 1984-03-06
K832906 PORT-A-CATH IMPLANTABLE CATHETER SYS Pharmacia, Inc. LLD Class II 1984-03-06
K840273 LOPEZ LOCK Icu Medical, Inc. FPA Class II 1984-03-06
K833398 MESULIN INSULIN INFUSION SET Molnlycke A/S Hospital Products FPA Class II 1984-03-06
K834044 MEDI-JECTOR II Derata Corp. KZE Class II 1984-03-06
K840683 FPP IV SECURE Fpp, Inc. KMK Class I 1984-03-06
K834548 HYPODERMIC SYRINGES & NEEDLES Cordis Corp. FMF Class II 1984-03-06
K840007 SURGICAL SUCTION INSTRUMENT-REUSABLE Lawton Surgical Instruments JOL Class II 1984-03-06
K840192 PISTON SYRINGE DISPOS. STERILE SYRING Interexpo Corp. FMF Class II 1984-03-06
K834091 SILCATH Hdc Corp. LJS Class II 1984-03-06
K840388 PAB IV CONTAINER American Mcgaw KPE Class II 1984-03-06
K834553 INTRADISCAL THERAPY TRAY Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1984-03-06
K840177 APPOSE ULE STERILE DISPOS. SKIN STAP Davis & Geck, Inc. GAG Class II 1984-03-05
K840178 APPOSE DISPOS. SKIN STAPLER W/AUTO Davis & Geck, Inc. GAG Class II 1984-03-05
K834368 SURGICAL DISPOSABLE STERILE & NONSTERIL Marbex, Inc. FMF Class II 1984-03-05
K834073 CENTRAL VEIN CATHERIZATION TRAY CC-20 Packaging Technologies, Inc. FOZ Class II 1984-02-28
K832847 MEDI-JECT Jack H. Ritterskamp KZH Class II 1984-02-28
K832470 INFUSION PUMP Delta Medical Industries FRN Class II 1984-02-28
K840034 VACUUM STRETCHER IMMOBILIZER Medicon, Inc. FPP Class I 1984-02-27
K834224 VACUUM REGULATOR 0-2000 MMHG VR-1000 Trimeter Instrument Corp. KDP Class II 1984-02-27
K834252 PBC EXTENSION SET Philadelphia Biologics Center FPA Class II 1984-02-27
K834253 PBC IV SET NON-VENTED Philadelphia Biologics Center FPA Class II 1984-02-27
K834254 PBC IV SET VENTED Philadelphia Biologics Center FPA Class II 1984-02-27
K840263 LIFECARE 4/HOMECARE - 4H PUMP Abbott Laboratories FRN Class II 1984-02-27
K840083 STERILE INSULIN DISPOS. NEEDLE/GREEN Lee Medical Intl., Inc. FMF Class II 1984-02-21
K840082 STERILE INSULIN DISPOS. NEEDLE/SYRINGE Lee Medical Intl., Inc. FMF Class II 1984-02-21
K840081 IV ADMINISTRATION SET Lee Medical Intl., Inc. FPA Class II 1984-02-21
K834528 MODEL 2001 INTELLIGENT INFUSOR Quest Medical, Inc. LDR Class II 1984-02-21
K833939 NITROGLYCERIN I.V. ADMINISTRATION SET Critikon Company, LLC FPA Class II 1984-02-21
K834467 SPECIMEN TRAP Microvasive BYZ Class II 1984-02-17
K834500 SOLUTION TRANSFER SET Berlex Laboratories, Inc. LHI Class II 1984-02-17
K832487 DRAW SHEET, ANTI-MICROBIAL American Threshold Industries, Inc. KME Class I 1984-02-13
K832486 PILLOW COVER, ANTI-MICROBIAL American Threshold Industries, Inc. KME Class I 1984-02-13
K834460 MODEL 1888 ALPHA COS/RESPIRATION CAR Spacelabs, Inc. LLK Class II 1984-02-13
K834225 RAAF DUAL LUMEN CATH. REPAIR KIT 2.2 Quinton, Inc. LJS Class II 1984-02-13
K834393 DESERET NEONATAL CATHETER SET Parke-Davis Co. FOZ Class II 1984-02-13
K834193 JAKOBI SURG. INSTRUMENTS #2 70/71 Imm Enterprises , Ltd. FRG Class II 1984-02-10
K832483 MATTRESS COVER, ANTI-MICROBIAL American Threshold Industries, Inc. FMW Class I 1984-02-04
K834480 INJECTION CAP Bd Becton Dickinson Vacutainer Systems Preanalytic FOZ Class II 1984-02-04
K833872 SAV-A-LIMB Sil-Med Corp. KYR Class I 1984-02-04
K834440 INJECTION AIDE UNIT FOR DIAGETICS Gottinger Co. KZH Class II 1984-02-04
K834062 STERILE LABELS Devon Industries, Inc. LDQ 1984-02-04
K834289 CONTINU-FLO SOLUTION ADMIN. 2C9102 Travenol Laboratories, S.A. FPA Class II 1984-01-30
K833755 ELECTRONIC DIGITAL FEVER THERMOMETER North American Philips Corp. FLL Class II 1984-01-30
K834130 INTRAVENOUS FILTER SET Tri-Med, Inc. FPA Class II 1984-01-30
K834461 INFUSION PUMP PRIMER Parker Hannifin Corp. FRN Class II 1984-01-30
K833964 PEGASUS MATTRESS Dermalex Co. FNM Class II 1984-01-30
K833723 MODEL 2000 AMBULATORY MED. INFUSER Parker Hannifin Corp. FRN Class II 1984-01-30
K840122 IURA AMBULANCE STRETCHER IAS-1 Trade West, Inc. FPO Class II 1984-01-27
K833731 BREATHABLE OVERWRAY BANDAGE NON-ELAS American Medical Disposable, Inc. KGX Class I 1984-01-27
K840124 IURA UNIVERSAL HOSPITAL STRETCHER-HS-13 Trade West, Inc. FPO Class II 1984-01-27
K833590 DRESS, SURGICAL ADHESIVE Lectec Corp. KGX Class I 1984-01-27
K840125 IURA UNIVERSAL WHEELCHAIR/STRETCHER- Trade West, Inc. FPO Class II 1984-01-27
K834138 HYPO SUTURE Medical Design & Manufacturing Corp. GAG Class II 1984-01-27
K833758 P.T.I. DRESSING CHANGE TRAYS Packaging Technologies, Inc. FMC Class I 1984-01-26
K834154 FLO-GARD 8000 COMPUTER CONTROL INFUSI Travenol Laboratories, S.A. LDR Class II 1984-01-25
K833674 ACCURATE MEASUREMENT DEVICE KG-AMD Sorensen Research GCX Class II 1984-01-25
K834071 LYMPHANGIOGRAPHY SET SPECIAL 30G Hyperion, Inc. FPA Class II 1984-01-25
K833258 SKIN TECH. SURGI-STRIPS Lee Tec Corp. FPX Class I 1984-01-25
K833754 HAMILTON PEDIATRICS SCALE Befour, Inc. FRW Class I 1984-01-11
K831802 LIFE VAC #2191 & 2192 Exco, Inc. LJS Class II 1984-01-11
K833837 AMERICAN GOLD SERIES AUTOCLAVE Tuttnauer Co. , Ltd. FLE Class II 1984-01-11
K833949 MICRO INFUSION SET Deltec Systems, Inc. FPA Class II 1984-01-11
K833568 DIATEK 600 THERMOMETER SYSTEM Diatek, Inc. FLL Class II 1984-01-10
K834129 MEDELA APGAR TIMER Medela, Inc. LHB Class I 1984-01-10
K833399 SYRINGE I M, Inc. FMF Class II 1984-01-10
K831728 MEDICALEX Medicalex FQM Class I 1984-01-09
K832774 REPAIR KITS FOR RIGHT ATRIAL CATH Quinton, Inc. LJS Class II 1984-01-03
K832580 RAAF CATHETER REPAIR KIT Quinton, Inc. LJS Class II 1984-01-03
K833083 DERMA STRIP-TM SKIN CLOSURES Howmedica Corp. FPX Class I 1983-12-30
K833673 ACCURATE MEASUREMENT DEVICE EZ-AMD Sorensen Research GCX Class II 1983-12-29
K833079 CENTRACATH #130,135 & 137-HEMOCATH # Exco, Inc. FOZ Class II 1983-12-29
K833457 ETHYLENE OXIDE GAS STERILIZA SYS II Ben Venue Laboratories, Inc. FLF Class II 1983-12-29

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