meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
34
Latest Decision
1995-09-01

Clearances · page 89 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K953781 INNOVATIVE TECHNOLOGIES CALCIUM ALGINATE WOUND DRESSINGS Innovative Technologies , Ltd. KMF Class I 1995-09-01
K951561 DYNASORB Dermarx Corp. KMF Class I 1995-09-01
K951939 TENDER TEMP Investech, Ltd. FLL Class II 1995-09-01
K950895 HARMAC EXTENSION INFUSION SET Harmac Medical Products, Inc. FPA Class II 1995-09-01
K953069 AMERIMED AS110 Amerimed Systems L.C. FNM Class II 1995-08-31
K951814 TRIUMPH-1 PORT Horizon Medical Products, Inc. LJT Class II 1995-08-29
K952274 CHEMOGUARD, P2 HIRISK Biosafety Systems, Inc. FMI Class II 1995-08-29
K944931 BECTON DICKINSON BLUNT STEEL CANNULA Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1995-08-29
K951018 LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER Siam Sempermed Corp., Ltd. LYY Class I 1995-08-28
K952405 CITRACE HOSPITAL GERMICIDAL DEODORIZER Caltech Industries, Inc. LRJ Class I 1995-08-28
K951020 TRI-CEN GERMICIDAL DETERGENT Central Solutions, Inc. LRJ Class I 1995-08-28
K944305 FRIEDRICH ELECTRONIC AIR CLEANER Friedrich Air Conditioning Co., Inc. FRF Class II 1995-08-28
K952336 DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH Caltech Industries, Inc. LRJ Class I 1995-08-28
K952626 MAPWIRE J-TIP SENSOR GUIDEWIRE Navion Biomedical Corp. LJS Class II 1995-08-25
K950824 STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS Stryker Corp. FMF Class II 1995-08-25
K950898 BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE) Biosystems MMK Class II 1995-08-24
K950153 VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES Imed Corp. FPA Class II 1995-08-24
K950897 BIOBOX TRAPTOP (SMALL, MEDIUM, LARGE AND X-LARGE) Biosystems MMK Class II 1995-08-24
K952760 FIXED FLOW RATE GRAVITY ADMINISTRATION SETS I-Flow Corp. FPA Class II 1995-08-18
K951281 R&D BATTERIS, INC. PART NUMBER 5024, 5027, 5033 AND 5035 R & D Batteries, Inc. FLL Class II 1995-08-18
K951402 R&D BATTERIES PART NOS. 5167, 5221, 5244 AND 5247 R & D Batteries, Inc. FLL Class II 1995-08-18
K951283 R&D BATTERIES, INC. PART NUMBERS 5075-B, 5076, 5122 AND 5123 R & D Batteries, Inc. FLL Class II 1995-08-18
K951735 JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL Joerns Healthcare, Inc. FNL Class II 1995-08-18
K951276 R&D BATTERIES, INC. PART NUMBERS 5412, 5420, 5436 AND 5438 R & D Batteries, Inc. FLL Class II 1995-08-18
K951278 R&D BATTERIES, INC. PART NUMBERS 5213, 5222, 5268 AND 5284 R & D Batteries, Inc. FLL Class II 1995-08-18
K951279 R&D BATTEERIES, INC. PART NUMBERS 5173, 5178, 5197 AND 5199 R & D Batteries, Inc. FLL Class II 1995-08-18
K951277 R&D BATTERIES, INC. PART NUMBERS 5295, 5334, 5344 AND 5410 R & D Batteries, Inc. FLL Class II 1995-08-18
K945873 HYPEX(TM) JET INJECTOR Equidyne Systems, Inc. KZE Class II 1995-08-18
K951403 R&D BATTERIES PART NOS. 5164, 5252, 5634 AND 5650 R & D Batteries, Inc. FLL Class II 1995-08-18
K951275 R&D BATTERIES, INC. PART NUMBERS 5453, 5474, 5513 AND 5595 R & D Batteries, Inc. FLL Class II 1995-08-18
K951399 R&D BATTERIES PART NOS. 5041 & 5655 R & D Batteries, Inc. FLL Class II 1995-08-18
K951274 R&D BATTRIES, INC. PART NUMBERS 5601, 5602, 5624 AND 5626 R & D Batteries, Inc. FLL Class II 1995-08-18
K951280 R&D BATTERIES, INC. PART NUMBERS 5003, 5006, 5008 AND 5012 R & D Batteries, Inc. FLL Class II 1995-08-18
K951284 R&D BATTERIES, INC. PART NUMBERS 5137, 5140, 5142 AND 5155 R & D Batteries, Inc. FLL Class II 1995-08-18
K951285 R&D BATTERIES, INC. PART NUMBERS 5158, 5168, 5171 AND 5172 R & D Batteries, Inc. FLL Class II 1995-08-18
K950012 DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES International Regulatory Consultants FMI Class II 1995-08-18
K951400 R&D BATTERIES PART NOS. 5064, 5157, 5489 AND 5536 R & D Batteries, Inc. FLL Class II 1995-08-18
K951401 R&D BATTERIES PART NOS. 5015, 5016, 5037 AND 5051 R & D Batteries, Inc. FLL Class II 1995-08-18
K951282 R&D BATTERIES, INC. PART NUMBERS 5039, 5052, 5056 AND 5061 R & D Batteries, Inc. FLL Class II 1995-08-18
K951404 R&D BATTERIES PART NOS. 5096, 5115, 5128 AND 5131 R & D Batteries, Inc. FLL Class II 1995-08-18
K945504 ACRYLIC DIPPED LATEX EXAMINATION GLOVES - STERILE Ganz Industries Sdn. Bhd. LYY Class I 1995-08-18
K952671 RATESAVER PLUS Entracare Corp. LZH Class II 1995-08-18
K942353 CENTURION UMBILICAL CATHETER Tri-State Hospital Supply Corp. FOS Class II 1995-08-15
K952649 WARM-SCALE Olympic Medical Corp. FRW Class I 1995-08-15
K952547 COVERSAN, ISLESAN Medical Device Development Co. KMF Class I 1995-08-14
K952197 GLOVETEX (MULTIPLE) Pt Mbf Buana Multicorpora LYY Class I 1995-08-14
K952590 ROYAL SHIELD NON-STERILE PINK COLOERED, STRAWBERRY SCENTED LATEX EXAMINATION GLOVES Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. LYY Class I 1995-08-14
K952526 CUTINOVA CAVITY Beiersdorf, Inc. KMF Class I 1995-08-14
K953011 FORMULATION HWS-64 EPA REG. NO. 47371-131 Huntington Laboratories, Inc. LRJ Class I 1995-08-11
K952591 ROYAL SHIELD NON-STERILE BLUE COLORED BUBBLE GUM SCENTED LATEX EXAMINATION GLOVES Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. LYY Class I 1995-08-11
K944721 9000 INFUSION PUMP Graseby Medical , Ltd. FRN Class II 1995-08-11
K952695 BOSTON MEDICAL LATEX EXAM GLOVES Shun Thai Rubber Gloves Industry Co., Ltd. LYY Class I 1995-08-11
K952851 SAFESKIN Safeskin Corp. LYY Class I 1995-08-11
K953009 FORMULATION HWS-128 EPA REG. NO. 47371-130 Huntington Laboratories, Inc. LRJ Class I 1995-08-11
K952589 ROYAL SHIELD PINK & BLUE COLORED NON-STERILE LATEX EXAMINATION GLOVES Shield Gloves Manufacturer (M) Sdn Bhd LYY Class I 1995-08-11
K953010 FORMULATION HWS-256 EPA REG. NO. 47371-129 Huntington Laboratories, Inc. LRJ Class I 1995-08-11
K952793 SAFESKIN Safeskin Corp. LYY Class I 1995-08-11
K945660 AUTOJECT 2 Owen Mumford USA, Inc. KZH Class II 1995-08-11
K952748 AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM** United States Surgical, A Division of Tyco Healthc LJT Class II 1995-08-10
K914749 WAVICIDE(R) -01 Wave Energy Systems, Inc. MED Class II 1995-08-10
K945374 ACU-HALT Eva-Health USA, Inc. LDQ 1995-08-09
K941098 SECURE-SITE Op-Co Medical Products , Ltd. KMK Class I 1995-08-09
K951273 BUXTON BUILT STERILIZER, BUXTON BUILT RECONDITIONED STERILIZER Buxton Medical Servic Corp. FLE Class II 1995-08-08
K952664 SOLUTION ADMINISTRATION SET Distronic Sterile Products, Inc. FPA Class II 1995-08-07
K953299 POLYKOTE Intl. Trade Management Co. LYY Class I 1995-08-07
K952407 REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER Contour Fabricators of Florida, Inc. KYZ Class I 1995-08-07
K952406 REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION Contour Fabricators of Florida, Inc. KYZ Class I 1995-08-07
K944961 PERSONAL ALARM SYSTEM (PAS) Cytoprobe Corp. LDQ 1995-08-07
K952392 MLI SET Medical Technologies of Georgia FPA Class II 1995-08-07
K945766 HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES Ansell, Inc. LYY Class I 1995-08-07
K951512 PRECISE HOSPITAL FOAM CLEANER DISINFECTANT Caltech Industries, Inc. LRJ Class I 1995-08-07
K943654 HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS Mdt Biologic Co. MLR Class II 1995-08-02
K951325 COMFEEL PLUS PRESSURE RELIEF DRESSING Richard Hamer Assoc., Inc. FMP Class I 1995-07-31
K952256 PICC LINE KIT Medi-Flex Hospital Products, Inc. FOZ Class II 1995-07-31
K951077 VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM Med Institute, Inc. LJT Class II 1995-07-31
K952757 ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE CATHETER Becton Dickinson Vascular Access, Inc. FOZ Class II 1995-07-31
K951078 CATHETER, INTRAVASCULAR OR PERCUTANEOUS Sims Deltec, Inc. LJS Class II 1995-07-31
K952861 ANGIOCATH & INSYTE AUTOGUARD CATHETERS Becton Dickinson Vascular Access, Inc. FOZ Class II 1995-07-31
K952196 IV POLE/STAND Valentine Intl. , Ltd. FOX Class I 1995-07-31
K952518 SAFE CAP NEEDLE RECAPPING/UNCAPPING DEVICE Medi-Dose, Inc. FMI Class II 1995-07-28
K952074 SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER Baxter Healthcare Corp FPA Class II 1995-07-27
K952302 AMUCHINA Amuchina Intl., Inc. LRJ Class I 1995-07-26
K951007 MORE CHAIN POWDER FREE VINYL EXAMINATION GLOVES Allerderm Laboratories, Inc. LYZ Class I 1995-07-26
K952093 ERGOMAT 5000 SYSTEM Ergo-Air, Inc. FNM Class II 1995-07-26
K952092 ERGOMAT 8000 SYSTEM Ergo-Air, Inc. FNM Class II 1995-07-26
K952243 EXTENSION SET/I.V. SET Coast Medical, Inc. FPK Class II 1995-07-26
K950597 CORE-RESISTANT HUBER INFUSION SET WITH Y-SITE Distronic Sterile Products, Inc. FPA Class II 1995-07-26
K952947 DELPORE SKIN CLOSURE Bitco Intl. FPX Class I 1995-07-24
K944669 FLEXIFLO QUANTUM ENTERAL PUMP Abbott Mfg., Inc. FRN Class II 1995-07-24
K952548 CELSITE VENOUS SYSTEM B.Braun Medical, Inc. LJT Class II 1995-07-21
K951431 AQUAGEL LUBRICATING JELLY Depuy Healthcare KMJ Class I 1995-07-21
K951918 SURGICAL TECHNOLOGIES, INC. SYRINGE Surgical Technologies, Inc. FMF Class II 1995-07-20
K941809 VINYL PATIENT EXAMINATION GLOVES Cheer & Merit Co., Ltd. LYZ Class I 1995-07-20
K952786 TRIFLEX STERILE SYNTHETIC EXAMINATION GLOVES Baxter Healthcare Corp LYZ Class I 1995-07-20
K946056 ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE) Ampri Rubberware Industries Sdn Bhd LYY Class I 1995-07-20
K952404 SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE Aladan Corp. LYY Class I 1995-07-20
K946046 DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP Deroyal Critical Care, Div. Deroyal Technologies FQZ Class I 1995-07-19
K943010 MAXILUBE Mission Pharmacal Co. KMJ Class I 1995-07-19
K951922 ADMINISTRATION SETS WITH BALL FLOAT Imed Corp. FPA Class II 1995-07-19
K941418 INFUSION PUMP I-Flow Corp. MEB Class II 1995-07-18

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