meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
40
Latest Decision
1980-12-30

Clearances · page 150 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K802992 ELASTIC GAUZE Abco Dealers, Inc. FQM Class I 1980-12-30
K802991 ROLL STRETCH GAUZE Abco Dealers, Inc. FQM Class I 1980-12-30
K803038 PROXIMATE*II DISPOSABLE SKIN STAPLER ETHICON, Inc. GAG Class II 1980-12-30
K802998 PATIENT CARE DISPOSABLE INFANT SHIRTS American Convertors Div., American Pharmaseal KME Class I 1980-12-22
K802901 TRAVENOL INFUSION PUMP-2M8016 Travenol Laboratories, S.A. FRN Class II 1980-12-17
K802897 ELECTRONIC DIGITAL THERMOMETER Philip J. Teders KPD Class II 1980-12-16
K802400 MS 16 SYRINGE DRIVER Princeton Medical Instruments, Inc. FRN Class II 1980-12-16
K802777 ARGYLE CONNECT TUBE-CON & NON Sherwood Medical Co. GAZ Class II 1980-12-11
K802785 ELASTIC BANDAGE Secol Co. FQM Class I 1980-12-11
K802634 STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. Organon, Inc. JOJ Class II 1980-12-11
K802837 DR. MICHAEL'S FOOT HELPER Dr. Michael'S Foot-Care Products LDQ 1980-12-10
K802780 JACKSON HYDRO SYSTEM S. Jackson, Inc. FNG Class II 1980-12-10
K802752 POROUS, BREATHING TAPE W/RELEASE LINER Bioadhesive Systems, Inc. KGX Class I 1980-12-10
K802702 NEONATAL PHOTOTHERAPY UNIT Ohio Medical Products LBI Class II 1980-12-10
K802730 FLUFF UNDERPAD TYPE UP1002 Bio D Corp. KME Class I 1980-12-10
K802784 ELASTIC OPEN WEAVE BANDAGE Secol Co. FQM Class I 1980-12-10
K802781 BEDDING PADS EGGCREATE PADS Leemart Bedding Mfg. Co. IKY Class I 1980-12-10
K802740 FLUFF UNDERPAD TYPE UP1001 Bio D Corp. KME Class I 1980-12-10
K802833 TETRA NATAL-MAT WATER FLOTATION MAT. Tetra Group U.S.A., Inc. IKY Class I 1980-12-10
K802789 TUBULAR BANDAGE Secol Co. FQM Class I 1980-12-10
K802795 ORTHOPEDIC PADDING Secol Co. KGX Class I 1980-12-10
K802820 TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP) Travenol Laboratories, S.A. FRN Class II 1980-12-10
K802229 CHEMICAL INDICATOR - KEM MED & BIO SURE Kem Medical Products Corp. JOJ Class II 1980-12-09
K802228 BIOLOGICAL INDICATOR - KEMMED & BIOSURE Kem Medical Products Corp. FRC Class II 1980-12-09
K802764 PLASTIC ADHESIVE BANDAGE Dyn-A-Med Products KGX Class I 1980-11-24
K802761 LATEX PENROSE TUBING CAT. #20400,414,416 American Hospital Supply Corp. GAZ Class II 1980-11-19
K802607 TERPERATUR SENSING DEVICE Burditt & Calkins-Siemens-Elema FLL Class II 1980-11-19
K802386 SUTURE WOUND TRAY MILFORD WHITTINSVILLE American Medical Disposable, Inc. FMC Class I 1980-11-12
K802385 CUSTOM DRESSING TRAY-WET TO DRY/MASS. American Medical Disposable, Inc. FPX Class I 1980-11-12
K802639 OHIO IC INCUBATOR Ohio Medical Products FMZ Class II 1980-11-12
K802611 AUTO SUTURE DISPOS., EEA SURG. STAPLER U. S. Surgical Corp. GAG Class II 1980-11-12
K802577 HYPERALIMENTATION SUBCLAVIIAN DRESS TRAY Associated Medical Products Co. FRG Class II 1980-11-12
K802166 MODEL AS* 7B AUTOSYRINGE INFUSION PUMP Baxter Healthcare Corp FLN Class II 1980-11-12
K802580 SUBCLAVIAN CATHETER INSERTION TRAY American Pharmaseal Div. Ahsc KXF Class I 1980-11-12
K802640 OHIO GC INCUBATOR Ohio Medical Products FMZ Class II 1980-11-12
K802384 CENTRAL VENOUS CATHETER DRESSING TRAY American Medical Disposable, Inc. FPX Class I 1980-11-12
K802011 INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 Pollak (Intl.), Ltd. FLN Class II 1980-10-31
K801837 PLASTIC STRIP BANDAGES Martin'S Maine Exchange FPX Class I 1980-10-31
K801791 FERTILITY AWARENESS METHOD KIT Telesis Corp. FLK Class II 1980-10-31
K802538 BASIN PACK Texas Medical Products, Inc. FNY Class I 1980-10-31
K802414 UMBILI-CATH CATHETER Int'L Corp. FOS Class II 1980-10-23
K802440 ARGYLE COMPACT CHEST DRAINAGE SYS. Sherwood Medical Co. GCX Class II 1980-10-23
K802041 AMPCO SHAVE PREP TRAYS, CAT.#SP4020 Associated Medical Products Co. LDQ 1980-10-23
K802301 CORDIS DOW INFUSION PUMP Cordis Corp. FRN Class II 1980-10-23
K802428 PROPPER SHARPGUARD & TRAYPAD STERIL. AID Propper Mfg. Co., Inc. FRG Class II 1980-10-23
K801734 IMED DROP RATE CALCULATOR #340 Imed Corp. FLN Class II 1980-10-23
K802365 OHIO RADIANT WARMER Ohio Medical Products FMT Class II 1980-10-23
K801517 BED ROCKING DEVICE Wesler FNJ Class I 1980-10-10
K802375 AMPCO SKIN SCRUB TRAY Associated Medical Products Co. FMC Class I 1980-10-10
K802366 NU-BORN BABY BATH KIT American Hospital Supply Corp. LDQ 1980-10-10
K801884 OP-SITE SKIN CLOSURE SUTURE ADHESIVE Acme United Corp. FPX Class I 1980-10-10
K802185 ARTERIAL BLOOD SAMPLING KIT Current Technologies, Inc. FMP Class I 1980-10-10
K802329 DISPOSABLE CONSTRAST DELIVERY SPIKE KIT Stanco Medical, Inc. FPA Class II 1980-10-03
K802126 ISOLETTE INCUBATOR C-100 Narco Air-Shields FMZ Class II 1980-09-26
K802174 ARGYLE SUCTION CANISTER W/DISP. LINER Sherwood Medical Co. KDQ Class II 1980-09-26
K802242 3M HI-STRENGTH MED. TAPE #1534 3M Company KGX Class I 1980-09-26
K802258 STOPCOCK 2-WAY, 3-WAY & 4-WAY Stanco Medical, Inc. FMG Class II 1980-09-26
K801537 START IT WITH & WITHOUT I.V. CATH. UNIT Pioneer Viggo, Inc. FOZ Class II 1980-09-19
K802073 MUELLER STRETCH M TAPE Mueller Chemical Co. KGX Class I 1980-09-16
K801979 ARGYLE COMPACT CHEST DRAINAGE SYSTEM Sherwood Medical Co. GCX Class II 1980-09-16
K802101 I.V. SENTRY ALARM DEVICE Pike Medical Co. FLN Class II 1980-09-16
K802016 EYE APPLICATORS CAT.#980-983 Pollak (Intl.), Ltd. KXF Class I 1980-09-16
K802004 PROFILE SWAB CAT.#5273 & 5274 Pollak (Intl.), Ltd. KXG Class I 1980-09-16
K802043 AMPCO SKIN SCRUB TRAYS, CAT.#SS843 Associated Medical Products Co. LDQ 1980-09-16
K801839 DISPOSABLE HYPODERMIC NEEDLES Martin'S Maine Exchange FMI Class II 1980-09-16
K802013 FIRST AID BANDAGE CAT.#198 OR 199 Pollak (Intl.), Ltd. KGX Class I 1980-09-16
K801942 OHIO THORACIC COLLECTION UNIT Ohio Medical Products GCX Class II 1980-09-16
K802042 AMPCO SKIN SCRUB TRAYS, CAT.#SS824 Associated Medical Products Co. LDQ 1980-09-16
K802147 SHILEY TEMPERATURE MONITOR Shiley, Inc. FLL Class II 1980-09-16
K801997 EMBOSSED DISP. POLY. GLOVES #5101-03 Pollak (Intl.), Ltd. FMC Class I 1980-09-09
K801990 ELASTIC BANDAGE CAT.#182-186 (WIDTH) Pollak (Intl.), Ltd. FQM Class I 1980-09-09
K801930 IVAC 811Y ELEC. CLINICAL THERMOMETER Y FLL Class II 1980-09-09
K802020 PREP SET CAT.#908 Pollak (Intl.), Ltd. KXF Class I 1980-09-09
K802044 AMPCO SKIN SCRUB TRAYS, CAT.#SS612 Associated Medical Products Co. LDQ 1980-09-09
K801998 STERILE EXAMINATION GLOVE #5121-5126 Pollak (Intl.), Ltd. FMC Class I 1980-09-09
K802015 FINGER PAINGUARD CAT.#193-194 Pollak (Intl.), Ltd. FQM Class I 1980-09-09
K801573 SAPCRILL THERMODETECT BREAST SCANNER DEV California Cardiac Systems, Inc. KYZ Class I 1980-09-09
K801924 HI-LO TEMP GEN. PURPOSE TEMP. PROBE National Catheter Co. Div. Mallinckrodt FLL Class II 1980-09-09
K802003 PLASTIC DISPOSABLE RAZOR CAT.#1017,1018 Pollak (Intl.), Ltd. LDQ 1980-09-09
K801871 PRIMARY SOLUTION ADMIN. SET-#86-01-0 260 Y FPA Class II 1980-08-27
K801904 SYRINGE INFUSION PUMP #2716 Harvard Apparatus, Inc. FRN Class II 1980-08-27
K801602 DESERET I.V. FILTER Hospital Products Co. FPB Class II 1980-08-27
K801873 MODEL 86-21-0 260 SECONDARY MEDICATION Y FPA Class II 1980-08-27
K801652 TOTAL PARENTERAL NUTRITION SET BAG Cutter Laboratories, Inc. KPE Class II 1980-08-27
K801546 THE SIMPLICITY PUMP #2100 INFUSION PUMP Critikon Company, LLC FRN Class II 1980-08-27
K801874 MODEL 86-21-1 260 APPROX. 60 DROPS/VENTD Y FPA Class II 1980-08-27
K801933 DRUALIFT 500 Independent Transfer Equipment Co. FNG Class II 1980-08-27
K801694 FLOTATION PAD FOR OPERATING TABLE Action Products, Inc. FMP Class I 1980-08-27
K801861 IVAC 260 SERIES VOLUME TRIC INFUSION CON Y LDR Class II 1980-08-27
K801941 BURRON MICROCATH INTRA. CATH. PLACEMENTT Burron Medical Products, Inc. FOZ Class II 1980-08-27
K801872 MODEL 86-01-1 260 SOLUTION ADMIN. SET Y FPA Class II 1980-08-27
K801936 PAD, EXAMINING TABLE Volunteer Blind Industries, Inc. KMN Class I 1980-08-27
K801423 RTM SYSTEM (REMOTE TEMPERATURE MONITOR) Remote Technologies, Inc. FLL Class II 1980-08-27
K801935 PAD, HOSPITAL STRETCHER Volunteer Blind Industries, Inc. FPO Class II 1980-08-27
K801333 AMPCO DRESSING CHANGE TRAYS Associated Medical Products Co. FRG Class II 1980-08-22
K801575 L-CATH INTRAVENOUS PLACEMENT UNIT Luther Medical Products, Inc. FOZ Class II 1980-08-20
K801331 AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS Associated Medical Products Co. FRG Class II 1980-08-20
K801796 THE COMFORT LIFT Gettner Enterprises, Inc. FMR Class I 1980-08-13
K801678 SPOR-TEST-STRIP Sterilization Technical Services, Inc. FRC Class II 1980-08-13
K801794 ELASTIC ADHESIVE BANDAGES(STERILE) Smith & Nephew, Inc. KGX Class I 1980-08-13

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