meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
37
Latest Decision
1983-03-31

Clearances · page 144 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K830605 PUMP PALL AMBULATORY INSULIN INFUSION Biomedical Devices, Inc. FRN Class II 1983-03-31
K830765 WINGED CATHETER Abbott Laboratories FOZ Class II 1983-03-31
K830454 IMS MINIATURE VOLUMETRIC INFUSION PUMP Ziehm International, Inc. FRN Class II 1983-03-31
K830544 WINDSOR MEDICAL, INC. 50-01-028 Windsor Medical, Inc. FRN Class II 1983-03-31
K830696 VENES ANTI EMBOLISM STOCKINGS Futuro Div. Jung Corp. DWL Class II 1983-03-31
K830317 INFUSION PUMP ACCESS. #60-01-5 Windsor Medical, Inc. FRW Class I 1983-03-31
K823527 SUBCLAVIAN INSERTION KIT Cunningham Woodland, Inc. FMF Class II 1983-03-31
K830490 MODEL 50-01-27 Windsor Medical, Inc. FRN Class II 1983-03-31
K830476 OR PREP KIT Clinipad Corp. FRG Class II 1983-03-31
K830194 IDAS INFUSION SET Idas America, Ltd. FPA Class II 1983-03-29
K830386 DAVOL SURGICAL SUCTION IRRIGATION INSTR C.R. Bard, Inc. FQH Class II 1983-03-29
K830671 THORAX-KLEX CHEST DRAINAGE UNIT C.R. Bard, Inc. KDQ Class II 1983-03-29
K830739 PRO-GUARD Surgicot, Inc. FRG Class II 1983-03-29
K830573 PRE VUE Taut, Inc. FOZ Class II 1983-03-29
K830561 DISPOSABLE TEMP. PROBE & CABLE MODELS Yellow Springs Instrument Co., Inc. FLL Class II 1983-03-24
K830654 INFUSION PUMP RETROGRADE EXTEN. AS 715 Narco Scientific FPA Class II 1983-03-24
K822842 AMBULATORY MARK I Windsor Medical, Inc. FRN Class II 1983-03-24
K830570 PERSONAL MEDICATION INFUSER Pacesetter Systems FRN Class II 1983-03-24
K830381 STERILE SAFETY PINS Devon Industries, Inc. GAZ Class II 1983-03-24
K830571 BOTTLE ADAPTER Burron Medical Products, Inc. KYX Class I 1983-03-24
K830552 LUER LOCK TEMPERATURE SENSOR Mon-A-Therm, Inc. FLL Class II 1983-03-17
K830343 CONTAINER W/PRIMING SOLUTION American Hospital Supply Corp. KDP Class II 1983-03-17
K830540 RENNCO MODEL LS LIFT SEAL HEAT SEALER Rennco, Inc. FRG Class II 1983-03-17
K830539 INTRAVASCULAR CATHETER SET Lab-A-Cath Corp. FOZ Class II 1983-03-17
K830572 CLEAN-FLUSH Burron Medical Products, Inc. KYZ Class I 1983-03-17
K830281 SKIN SCRUB PREP. TRAY Zoa, Inc. FRG Class II 1983-03-11
K822735 SURE-COUNT DISPOSABLE NEEDLE COUNTER Geneva Laboratories, Inc. MMK Class II 1983-03-09
K830559 HEALTHCARE MODEL #175/176 BED SERIES G.W. Healthcare, Inc. FNL Class II 1983-03-09
K830565 SECURA SET SECONDARY ADMIN. SET Diatek, Inc. FPA Class II 1983-03-09
K830193 CAT 3040 Burron Medical Products, Inc. KPE Class II 1983-03-09
K823077 URINARY BLADDER TEMP. SENSOR #81-003 Clinical Technology Corp. FLL Class II 1983-03-09
K830275 NEEDELET HANDLER FOR SHARPS Ritmed, Inc. MMK Class II 1983-03-08
K830106 UNICIDE North Pacific Dental, Inc. LFE Class II 1983-03-07
K830423 SYRINGE DRIVER MS-16 Intermedics, Inc. FRN Class II 1983-03-07
K823845 PORT-LOCK Norfolk Medical Products, Inc. FPA Class II 1983-03-01
K830300 FREHAN INC. I.V. FILTER HOLDER Saxnor Corp. KMK Class I 1983-03-01
K830000 VASCULAR-ACCESS-PORT Norfolk Medical Products, Inc. LJT Class II 1983-03-01
K830450 DELMED IV CONTAINER Delmed, Inc. KPE Class II 1983-03-01
K830355 SECURA IV VOLUMETRIC INFUSION PUMP Diatek, Inc. FRN Class II 1983-03-01
K830256 NON-STERILE BROVIAC PARENTERAL ALIMI- Evermed, Inc. LJS Class II 1983-03-01
K830406 NON-STERILE CATHETER REPAIR KITS Evermed, Inc. LJS Class II 1983-03-01
K830377 SECURA SET PRIMARY ADMIN. SET Diatek, Inc. FPA Class II 1983-03-01
K830233 NON-STERILE,SINGLE/SOUBLE LUMEN-CATH Evermed, Inc. LJS Class II 1983-02-28
K830102 HARVARD APPARATUS INTERMITTENT INFUSION C.R. Bard, Inc. FRN Class II 1983-02-28
K823493 CHECK MATE #1850 ELEC. DIGITAL THERMO Bristoline, Inc. FLL Class II 1983-02-28
K830273 COUNTWAY SYS. SOILED SPONGES-BLOOD LOS Ritmed, Inc. FQA Class I 1983-02-28
K830448 SECURA SET VOLUME LIMITING SET Diatek, Inc. FPA Class II 1983-02-25
K830039 SDC RECTAL TEMP. PROBE PRODUCT #1020 Science Development Corp. FLL Class II 1983-02-23
K823457 NON-PRESSURE AUTOCLAVE FOR STERILIZATION Interdent, Inc. FLE Class II 1983-02-23
K830299 SOLUTION TRANSFER CONTAINER The Healthcare Group Laboratories, Inc. KPE Class II 1983-02-19
K830151 EXTERNAL INFUSION PUMP Intermedics, Inc. FRN Class II 1983-02-18
K830171 DIGITAL BEDSIDE SCALE #5000 Acme Medical Scale Co. FRW Class I 1983-02-18
K830200 MICROELISA MINIREADER II Dynatech Corp. LBI Class II 1983-02-16
K830258 CENTAURSET 300 & 300 P.E.D Centaur Sciences, Inc. FPA Class II 1983-02-15
K830242 MICRO 2 HYPODERMIC NEEDLES Smith & Nephew, Mpl Division FMI Class II 1983-02-15
K830232 DECANTER MODELS-VARIOUS Steri-Sytems, Corp. KPE Class II 1983-02-09
K813265 3M STERI-STRIP ANTIMICROBIAL SKIN CLOS 3M Company KGX Class I 1983-02-09
K830152 MINILOOP I.V. CONNECTORS & ADAPTOR Medex, Inc. FPA Class II 1983-02-09
K830178 MINILOOP DISPOS. IV CONNECTORS ADAPT. Medex, Inc. FPA Class II 1983-02-07
K830177 HARVARD APPARATUS FAMILY OF FLUID INFUS C.R. Bard, Inc. FRN Class II 1983-02-07
K823693 MYELOGRAPHY NEEDLE Ocean Medical Products, Ltd. FMI Class II 1983-02-07
K830198 PEDIATRIC EXTEN. SET FOR SECOND-DRUG Travenol Laboratories, S.A. FMG Class II 1983-02-07
K823696 MICRO Z BLOOD COLLECTING NEEDLES Hospital Products Co. FMI Class II 1983-01-26
K830038 SIGMA 7000-6000 INFUSION PUMPS Sigma FRN Class II 1983-01-26
K823538 POUR BOTTLE DECANTER #2010 Medi-Plant Intl. KPE Class II 1983-01-26
K830057 20 MICRON HIGH CAPACITY TRANS/FILTER Travenol Laboratories, S.A. CAK Class II 1983-01-26
K820038 SIGMA 7000 Sigma FRN Class II 1983-01-26
K823018 MODEL 460 INTERMITTENT MEDICATION DELIV Y FLN Class II 1983-01-26
K830017 VOLUMETRIC PUMP ADMIN. SETS Travenol Laboratories, S.A. FRN Class II 1983-01-26
K823821 SIDE RAIL PADS Danek Medical, Inc. FNJ Class I 1983-01-21
K822817 DOCE ALL-IN-THE-EAR AID Fidelty Hearing Instruments, Inc. FSD Class I 1983-01-18
K830014 HEMA - NV TRANS. BLOOD FILTER 100/800 Abbott Laboratories CAK Class II 1983-01-17
K823776 PI-PNEUMO-INTESTINAL INSTRUMENT SET Surgeons Choice, Inc. GAG Class II 1983-01-14
K823737 MADE-TO-MEASURE SURGICAL ELASTIC SUPPORT Gotfried Medical, Inc. DWL Class II 1983-01-12
K823838 INFUSE-A-PORT Infusaid Corp. LJT Class II 1983-01-12
K823221 ACCA-TEMP SKIN TEMP. VINYL DISC T. G. & E. Medical KPD Class II 1983-01-12
K823214 DOSIMETRIC RELEASE PROGRAM - ADMIN. SET Cutter Laboratories, Inc. FPA Class II 1983-01-12
K823076 SATOBAN FIRST AID TAPE Food and Drug Service, Inc. KGX Class I 1983-01-12
K823333 MODEL 400 & 700 TEMP. SENSOR ADAPTERS Mon-A-Therm, Inc. FLL Class II 1983-01-12
K823902 EAGLE STERISET American Sterilizer Co. FRG Class II 1983-01-09
K823261 INTERFACE TRANSFUSION BLOOD FILTER #30 Medical, Inc. CAK Class II 1983-01-07
K823513 CENTRAL SUPPLY ROOM WRAP James River Corp. FRG Class II 1983-01-07
K823789 ELASTIC COMPRESSION ANKLET Orthopaedic Resources Corp. FQL Class I 1983-01-07
K823553 CORCATH H & B VASCULAR ACCESS CATHETER Cormed, Inc., Sub. C.R.Bard, Inc. LJS Class II 1983-01-05
K823373 BENZING RETROGRADE ADMIN. SET Beech Medical, Inc. FMG Class II 1982-12-30
K823469 TERUFUSION THREE-WAY STOPCOCK Terumo Medical Corp. FMG Class II 1982-12-30
K823690 IVFLO-HP & IVFIL-HP Tri-Med, Inc. FPB Class II 1982-12-28
K823406 GUARDIAN 110, VOL. CONTROL DELIV. SYS Avi, Inc. FRN Class II 1982-12-22
K823404 VOLUMERIC CONTROLLER Quest Medical, Inc. LDR Class II 1982-12-22
K823565 MULTI-LUMEN INTRAVENOUS CATHETER Mcpherson Enterprises, Inc. FOZ Class II 1982-12-16
K823351 CENTRAL VENOUS CATHETER Plasmedics, Inc. FOZ Class II 1982-12-09
K823208 MYSTIK AUTOCLAVE TAPE Mystik Corp. JOJ Class II 1982-12-09
K823350 ELASTIC COMPRESSION ANKLET Podiatry Products Corp. FQL Class I 1982-12-03
K823063 FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB Travenol Laboratories, S.A. FRN Class II 1982-11-30
K823204 BETATRON II Cardiac Pacemakers, Inc. FRN Class II 1982-11-30
K823346 ACCUSET ADMINISTRATION SET Imed Corp. FPA Class II 1982-11-30
K823193 AMBULATORY INSULIN INFUSION PUMP 9205 Cpi, Inc. FRN Class II 1982-11-30
K822891 FLO CONTROL Dna Medical, Inc. LDR Class II 1982-11-24
K823347 MACRODOT ADD-I-MED ADMIN. SET Imed Corp. FPA Class II 1982-11-24
K822939 HEART RATE & TEMP. MEASUREMENT SYSTEM Camino Laboratories, Inc. FLL Class II 1982-11-24

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