meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
39
Latest Decision
1985-11-18

Clearances · page 135 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K854346 MEDIFLEX DISPOSABLE TUBING CLAMP Mediflex Intl. FPA Class II 1985-11-18
K853393 INSULIN PUMP INSUMAT 229 Medix Medical Electronics (U.S.A.), Inc. FRN Class II 1985-11-18
K854257 COMBO 36 Kg Engineering, Inc. FNJ Class I 1985-11-18
K852254 I.V. STAT MASTER The Master Medical Corp. FPA Class II 1985-11-18
K852167 ISOVOL-EXCHANGE TRAY Rocky Mountain Medical Corp. BRZ Class II 1985-11-18
K853270 CENTERCOM CONTROL Carrom Healthcare, Inc. FNL Class II 1985-11-13
K853653 SANA-LUBE Huntington Laboratories, Inc. KMJ Class I 1985-11-13
K852503 R.R. PRONTO SIRINGA Medical Hospital Equipment FMF Class II 1985-11-13
K854008 STATLOCK Healthtek, Inc. LHI Class II 1985-11-13
K850792 ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP Janssen Pharmaceutica, Inc. FRN Class II 1985-11-13
K853584 CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP Deltec Systems, Inc. FRN Class II 1985-11-12
K853019 NITROGLYCERIN INFUSION SET Lyphomed, Inc. FPA Class II 1985-11-12
K853604 ACE-KYLE DYE INJECTION NEEDLE P/N 14082 Today'S Machining & Design, Inc. FMI Class II 1985-11-12
K854255 SPAN / AID SYRINGE Span-America Medical Systems, Inc. FMF Class II 1985-11-12
K854035 MICRO THERM MT-500 & MT-600 Medequi, Division of King Yip Co., Inc. FLL Class II 1985-11-12
K853549 MCGAW/DROP WATCH FLOW MONITOR American Mcgaw FLN Class II 1985-11-12
K854304 KEYMED OFFICE COUCH Keymed, Inc. FPO Class II 1985-11-12
K853970 ALPHA CHUCK Rocky Mountain Medical Corp. KME Class I 1985-11-08
K854007 MICROTHERM MT-501 & MT-502 Medequi, Division of King Yip Co., Inc. FLL Class II 1985-11-08
K852943 NEO SHIELD Gaymar Industries, Inc. FMT Class II 1985-11-08
K853130 INTEGRATED DISPLAY TECHNOLOGY LTD. Integrated Display Technology, Ltd. FLL Class II 1985-11-08
K854348 CHURCHILL 3-WAY STOPCOCK SET Churchill Corp. FMG Class II 1985-11-08
K853824 DIGITAL THERMOMETER Epson America, Inc. FLL Class II 1985-11-08
K854031 SNAP-LOCK ADDITIVE CAP #SL100 Williams Medical Co. KPE Class II 1985-11-06
K854034 SNAP-LOCK ADDITIVE CAP #SL 300 Williams Medical Co. KPE Class II 1985-11-06
K853830 SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST Travenol Laboratories, S.A. LHI Class II 1985-11-06
K854033 SNAP-LOCK ADDITIVE CAP #SL400 Williams Medical Co. KPE Class II 1985-11-06
K853322 MEDTRONIC ACCESS PORT MODEL 8500 Medtronic Vascular LJT Class II 1985-11-06
K853134 NATIONAL MED CARE INFUSION PUMP ADM SET #95-0001-8 Erika, Inc. FRN Class II 1985-11-06
K854082 PORTA-POLE TM MEDICAL EQUIPMENT POLE W/FOLD Gray Wave Corp. FOX Class I 1985-11-01
K852115 ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER Ars Enterprises, Inc. FLF Class II 1985-11-01
K854032 SNAP-LOCK ADDITIVE CAP #SL 200 Williams Medical Co. KPE Class II 1985-11-01
K842905 TRAVENOL MULTIDAY INFUSOR 2C1080 Travenol Laboratories, S.A. FRN Class II 1985-11-01
K852192 DISPOSABLE STEAM BIOLOGICAL TEST PACK Parke-Davis Co. FRC Class II 1985-11-01
K854120 MURRAY CHAIR LIFT J.B. Murray Enterprises, Inc. FNG Class II 1985-11-01
K853713 FIRST TEMP Intelligent Medical Systems FLL Class II 1985-11-01
K854063 MICROVASIVE SILICONE SPRAY Microvasive KCT Class II 1985-10-25
K853731 HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX Gish Biomedical, Inc. FMI Class II 1985-10-18
K850884 ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER Sherwood Medical Co. FOS Class II 1985-10-17
K853287 HUBOUT I M, Inc. FPA Class II 1985-10-17
K852467 VIAL VENT FILTER Baxter Healthcare Corp LHI Class II 1985-10-17
K853701 JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL Critikon Company, LLC FOZ Class II 1985-10-17
K853351 OHMEDA HEAT REFLECTING PATCH Ohmeda Medical FMT Class II 1985-10-17
K852443 PHARMA-PLAST CLINIPAK Pharma-Plast USA, Inc. FMF Class II 1985-10-16
K853880 ATTENDS DISPOS. UNDERPAD Procter & Gamble Mfg. Co. KME Class I 1985-10-16
K853515 PEE WEE THERMOMETERS Joel R.L. Ehren Kranz FQZ Class I 1985-10-16
K853794 NEOGUARD REFLECTOR Cas Medical Systems, Inc. FMT Class II 1985-10-16
K852444 ASIK 'ONCE' SYRINGE Pharma-Plast USA, Inc. FMF Class II 1985-10-16
K853075 MEDNOVA SAFETY BAG Mednova Corp. LHI Class II 1985-10-16
K853155 BOEHRINGER LAB SUCTION INTERRUPTER Boehringer Laboratories KDP Class II 1985-10-16
K853838 JMS LCC INSULIN SYRINGE Jms Co., Ltd. FMF Class II 1985-10-16
K853820 SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE Abco Dealers, Inc. KGX Class I 1985-10-16
K852938 TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK Northern Customfab, Inc. KPE Class II 1985-09-30
K852114 ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000 Ars Enterprises, Inc. FLE Class II 1985-09-27
K852113 ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 Ars Enterprises, Inc. FLE Class II 1985-09-27
K853527 JUFREY CORP. UNIV. DISPOS. SCALP VEIN INFUSION SET Jufrey Multimed Corp. FPA Class II 1985-09-23
K853355 N.K. PEDIATRIC CRIBS N.K. Medical Products, Inc. FMS Class II 1985-09-20
K852893 VIAL DECANTER Advance Medical Designs, Inc. KPE Class II 1985-09-20
K852990 PAO VALUE Ackard Laboratories FMF Class II 1985-09-20
K852304 SAFE-N-JECT Gerstner Intl. Trade FMF Class II 1985-09-20
K852442 PHARMA-PLAST NEEDLE Pharma-Plast USA, Inc. FMI Class II 1985-09-20
K853418 SAFTI-BRACELET Advanced Biosearch Assn. KMK Class I 1985-09-20
K852819 STERILE DISPOSABLE SYRINGE(3 PIECES) Fabersanitas, S.A. FMF Class II 1985-09-20
K852996 DYNA GARD SYRINGE FILTER Microgon, Inc. FPB Class II 1985-09-19
K853421 THE KEYMED VARI-HEIGHT PATIENT COUCH Keymed, Inc. FPO Class II 1985-09-19
K853212 FLOW EASE(PLASTIC VENTED NEEDLE) Acacia, Inc. LHI Class II 1985-09-19
K853645 NITTO SURGICAL CLOTH TAPE ST-330 Nitto Denko America, Inc. KGX Class I 1985-09-19
K853646 NITTO SURGICAL NON-WOVEN TAPE ST-320 Nitto Denko America, Inc. KGX Class I 1985-09-19
K852606 FLEBOSET 1401(60 DROPS/MI) AND FLEBOSET1400(20) Infarkem Corp. FPA Class II 1985-09-19
K853644 NITTO SURGICAL PLASTIC TAPE ST-356 Nitto Denko America, Inc. KGX Class I 1985-09-19
K852831 NON-KOR ACCESS KITS Creative Care Systems, Inc. FMI Class II 1985-09-19
K853647 NITTO SURGICAL PAPER TAPE ST-310 Nitto Denko America, Inc. KGX Class I 1985-09-19
K853551 YSI MODEL 790 TELE-THERMOMETER Yellow Springs Instrument Co., Inc. FLL Class II 1985-09-19
K852335 STERILIZATION CONTAINER Bemis Mfg. Co. FRG Class II 1985-09-16
K853475 GRAM-MA NEONATAL SC Kentec Medical, Inc. FRW Class I 1985-09-05
K853204 CHURCHILL VENTED IV SET Churchill Corp. FPA Class II 1985-09-05
K852949 WELCH ALLYN #48100 TASK LITE W/ACCESSORIES AS LIST Welch Allyn, Inc. KZF Class I 1985-09-04
K853145 KENDALL CURITY BURN PAD The Kendal Co. FPY Class I 1985-08-30
K851516 CHERMEL SCALP VEIN SET Cher Mel Corp. FPA Class II 1985-08-23
K853255 OMNIMED I.V. SOLUTION ADMIN. SET Omni Intl., Inc. FPA Class II 1985-08-23
K853385 I.A.S.S., IV SET W/AIR VENT & I.A.P.S. W/O AIRVENT Migada, Ltd. FPA Class II 1985-08-23
K853095 BOEHRINGER LABORATORIES SUCTION INTERMITTOR Boehringer Laboratories GCX Class II 1985-08-23
K853176 CANNON BABYSAFE NIPPLE SHIELDS Medela, Inc. HFS Class I 1985-08-22
K853386 MULTISET 40 Migada, Ltd. BRZ Class II 1985-08-22
K853387 ET - EXTENSION SETS Migada, Ltd. FPA Class II 1985-08-22
K853188 TRANSFER DEVICE Advance Medical Designs, Inc. LHI Class II 1985-08-21
K852965 ENTERAL FEEDING PUMP Empire Industries, Inc. FRN Class II 1985-08-21
K853327 JUFREY CORP. UNIVERSAL DISPOS. SCALP VEIN INFUSION Jufrey Multimed Corp. FPA Class II 1985-08-21
K853185 CUDDLE CUSHION The Cuddle Co. LDQ 1985-08-20
K851816 SARTORIUS MINISART FH 16534 Sartorius Filters, Inc. FPB Class II 1985-08-19
K853086 SECONDARY ADMINISTRATION SET Lyphomed, Inc. FPA Class II 1985-08-19
K851817 SARTORIUS MINI-SART FH 16555 Sartorius Filters, Inc. FPB Class II 1985-08-19
K851818 SARTORIUS MINI SART FH 16592 Sartorius Filters, Inc. FPB Class II 1985-08-19
K852777 BAG DECANTER Advance Medical Designs, Inc. KPE Class II 1985-08-16
K853275 CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD Icu Medical, Inc. FMG Class II 1985-08-16
K852454 CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM Gambro, Inc. FLL Class II 1985-08-16
K852882 MAXIFILL TRANSFER SET Lyphomed, Inc. LHI Class II 1985-08-16
K852881 VENTED SECONDARY IV ADMINISTRATION SET Lyphomed, Inc. FPA Class II 1985-08-16
K852778 BOTTLE DECANTER Advance Medical Designs, Inc. KPE Class II 1985-08-16
K853296 EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN Parexel Intl. Corp. BYY Class II 1985-08-15

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