meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
27
Latest Decision
1990-01-12

Clearances · page 114 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K896428 SEMPERMED LATEX EXAMINATION GLOVES Semperit Industrial Products LYY Class I 1990-01-12
K895993 VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE Vitaphore Corp. KMK Class I 1990-01-11
K896177 SKED STRETCHER Skedco, Inc. FPP Class I 1990-01-11
K891277 PATIENT EXAMINATION GLOVES (LATEX) Grace River Ent., Inc. LYY Class I 1990-01-11
K896333 CMS IV FILTERS Churchill Medical Systems, Inc. FPB Class II 1990-01-11
K896046 VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE Vitaphore Corp. KMK Class I 1990-01-11
K894752 PVC EXAMINATION GLOVES Dan Dong Linsen Plastic Industrial Co., Ltd. LYZ Class I 1990-01-11
K896179 SKED FLOTATION SYSTEM Skedco, Inc. FPP Class I 1990-01-11
K896320 CENTURION KLEEN-NEEDLE SYSTEM Tri-State Hospital Supply Corp. FMI Class II 1990-01-11
K892180 PATIENT EXAMINATION GLOVES (VINYL) Singfar Ent. Co. , Ltd. LYZ Class I 1990-01-11
K896161 AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA. 3M Company FPA Class II 1990-01-11
K895674 MEDICOOL, CONTAINER FOR STORING INSULIN Medicool, Inc. LDQ 1990-01-11
K892078 SENSI TOUCH PATIENT EXAM GLOVES (VINYL) Taiwan Old Shop Corp. LYZ Class I 1990-01-11
K892702 PATIENT EXAMINATION GLOVES (LATEX) P.T. Daifatex Indah LYY Class I 1990-01-10
K892287 PATIENT EXAMINATION GLOVES (LATEX) Supermax Sdn Bhd LYY Class I 1990-01-10
K892562 PATIENT EXAMINATION GLOVES (LATEX) Yiu Tsun Industrial Co., Ltd. LYY Class I 1990-01-10
K894437 PEEL-VUE AUTOCLAVE/CHEMICALVE POUCH Clive Craig Co. FRG Class II 1990-01-10
K894376 LATEX EXAMINATION GLOVES P.T. Haluwiko Pratita LYY Class I 1990-01-10
K896944 CN CARE STERILE LATEX EXAMINATION GLOVES C.N. Technocrats LYY Class I 1990-01-10
K895237 LATEX PATIENT EXAMINATION GLOVES China Shanghai SI DA Latex & Plastics Co. , Ltd. LYY Class I 1990-01-10
K896043 MATTRESS COVER FOR MEDICAL PURPOSES Keystone Veterinary Supplies, Inc. KME Class I 1990-01-10
K895228 PATIENT EXAMINATION GLOVES Ray Intl. Co. LYY Class I 1990-01-10
K896023 OHMEDA 9000 SYRINGE PUMP Ohmeda Medical FRN Class II 1990-01-04
K896076 L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R) Advance Medical Designs, Inc. LZC Class I 1990-01-04
K893233 DISPOSABLE NEEDLE, ASPIRATION AND INJECTION Pioneer Intl. Co. FMF Class II 1990-01-04
K895797 IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE Imed Corp. FRN Class II 1990-01-02
K894121 PATIENT EXAMINATION GLOVES Pro-Tex Products, Inc. LYY Class I 1990-01-02
K895660 ANSELL DENTA GLOVES Ansell, Inc. LYY Class I 1990-01-02
K892779 PATIENT EXAMINATION GLOVES Jamuri Sdn. Bhd. LYY Class I 1990-01-02
K896604 MAL LATEX EXAMINATION GLOVES Pt. Maja Agung Latexindo LYY Class I 1990-01-02
K896962 TINY HALOGEN EXAM LIGHT Jedmed Instrument Co. KZF Class I 1989-12-29
K891986 MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE Mark One Healthcare Products KME Class I 1989-12-29
K895291 IV DISPESNSING SPIKE The Medi-Dose Group FPA Class II 1989-12-27
K896774 STREAMLINE VASCULAR ACCESS DEVICE Menlo Care, Inc. FOZ Class II 1989-12-27
K895290 CHEMO-SPIKE RECONSTITUTION DEVICE The Medi-Dose Group FPA Class II 1989-12-27
K896593 BECTON DICKINSON RATE INFUSER II SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic FRN Class II 1989-12-27
K893461 LATEX EXAMINATION GLOVES Zhum Heng Development , Ltd. LYY Class I 1989-12-27
K895426 AMBULATORY INFUSION PUMP Bionica, Inc. FRN Class II 1989-12-27
K895884 BANDAGE REMOVAL STRIP Kut-Guard, Inc. KGX Class I 1989-12-27
K895689 LIFEPORT VASCULAR ACCESS PORT Strato Medical Corp. LJT Class II 1989-12-27
K896003 LATEX EXAMINATION GLOVES Jiea Chao Ent. Co., Ltd. LYY Class I 1989-12-27
K896261 THE SMITHCOT Ram Marketing, Inc. FPP Class I 1989-12-22
K894028 AMBULATORY INFUSION SYSTEM AND ACCESSORIES Patient Solutions, Inc. FRN Class II 1989-12-22
K895875 MODEL 4070 TEMPERATURE MONITOR Mallinckrodt Anesthesia Products FLL Class II 1989-12-21
K892633 PATIENT EXAMINATION GLOVES (LATEX) Gobo Intl. LYY Class I 1989-12-21
K895754 LATEX PATIENT EXAMINATION GLOVES Frontline Latex Products Pvt. , Ltd. LYY Class I 1989-12-21
K893632 PATIENT EXAMINATION GLOVES Pro Asia, Inc. LYY Class I 1989-12-21
K892194 PATIENT EXAMINATION GLOVES (LATEX) Pao Chen Industrial Co., Ltd. LYY Class I 1989-12-20
K896489 TOYOSUYA LATEX EXAMINATION GLOVES Toyosuya Sdn Bhd LYY Class I 1989-12-20
K896411 REVISED PATIENT EXAMINATION GLOVES Pt. Trihasta Loka Persada LYY Class I 1989-12-20
K894900 LATEX PATIENT EXAMINATION GLOVES Fujian Ming Sheng Chemistry LYY Class I 1989-12-20
K896275 JEDMED J-II CHAIR Jedmed Instrument Co. FRK Class I 1989-12-18
K895807 STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC' Safeskin Corp. LYY Class I 1989-12-18
K894611 CATHETER CARE KITS L H M Ent., Inc. FOZ Class II 1989-12-15
K895712 PERCUTANEOUS INTRAVENOUS CATHETERS Pharmacia Deltec, Inc. LJS Class II 1989-12-15
K895408 OPSITE*WOUND (FLEXIGRID APPLICATION SYSTEM) Smith & Nephew United, Inc. KGX Class I 1989-12-14
K895848 PRESSURE STEAM STERILIZERS Scientific Device Laboratory, Inc. FLE Class II 1989-12-11
K892636 PATIENT EXAMINATION GLOVES (LATEX) P.T. Latexindo Parama LYY Class I 1989-12-11
K896306 GLOVE N GEL Ems Medical, Inc. LYY Class I 1989-12-11
K895637 LATEX EXAM GLOVES (MFG. SUPER GLOVE INDUSTRY CO.) Transcontinental Fertilizer Co. LYY Class I 1989-12-11
K896399 WHITE MAGNOLIA DENUDATE LATEX EXAMINATION GLOVES Prime Horizon, Inc. LYY Class I 1989-12-11
K895657 PATIENT EXAMINATION GLOVES (NON STERILE) Ka Hung Development , Ltd. LYY Class I 1989-12-11
K892091 PATIENT EXAMINATION GLOVES (LATEX) Rising Crown Industries , Ltd. LYY Class I 1989-12-11
K894213 SPRING LATEX EXAMINATION GLOVES Brandywine Surgical, Inc. LYY Class I 1989-12-11
K893513 PATIENT EXAMINATION GLOVE/MANUF. KUN SHAN FACTORY Pioneer Sundries Products , Ltd. LYY Class I 1989-12-11
K896292 1.2 MICRON FILTER WITH IV SET Kendall Mcgaw Laboratories, Inc. FPB Class II 1989-12-08
K895630 B-D PEND NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1989-12-08
K895550 K-1 INFANT TRANSPORT SYSTEM K-1 Medical Products, Inc. FMZ Class II 1989-12-07
K895703 DIATEK MODEL 700 THERMOMETER Diatek, Inc. FLL Class II 1989-12-07
K895782 NEONATAL INCUBATOR (ACCESSORY) Air-Shields Vickers, Inc. FMZ Class II 1989-12-07
K896093 A-PORT IMPLANT. VASCULAR ACCESS SYSTEM - A2PORT Therex Corp. LJT Class II 1989-12-06
K893646 VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY Baxter Healthcare Corp FPA Class II 1989-12-06
K891237 MODEL 600 SYRINGE PUMP 3M Company FRN Class II 1989-12-06
K895322 LATEX EXAMINATION GLOVES Advantage Resources LYY Class I 1989-12-05
K893357 LATEX EXAMINATION GLOVES M.M. Rubber Co. , Ltd. LYY Class I 1989-12-05
K895642 LATEX PATIENT EXAMINATION GLOVES Siam Sempermed Corp., Ltd. OPE 1989-12-05
K891719 TRU-TOUCH VINYL, NON-STERILE Bd Becton Dickinson Vacutainer Systems Preanalytic LYZ Class I 1989-12-05
K892327 TRU-TOUCH VINYL, STERILE Bd Becton Dickinson Vacutainer Systems Preanalytic LYZ Class I 1989-12-05
K896220 NON-STERILE LATEX EXAMINATION GLOVES Allstar Sdn. Bhd. LYY Class I 1989-12-05
K892073 TAGUM LATEX EXAMINATION GLOVES Tagum Rubber Industries, Ltd. LYY Class I 1989-12-05
K892926 DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS Vas-Cath, Inc. LJS Class II 1989-12-05
K892328 FEATHERWEIGHT VINYL, NON-STERILE EXAM GLOVES Bd Becton Dickinson Vacutainer Systems Preanalytic LYZ Class I 1989-12-05
K894308 PATIENT EXAMINATION GLOVES Xing Huao Co. , Ltd. LYY Class I 1989-12-05
K892279 PATIENT EXAMINATION GLOVES Aek Rubber Product Sdn. Bhd. LYY Class I 1989-12-01
K896207 OSBON PERSONAL LUBRICANT Osbon Medical Systems, Ltd. KMJ Class I 1989-12-01
K895488 LATEX PATIENT EXAMINATION GLOVES Zhong YI Latex Products Factory LYY Class I 1989-12-01
K883400 OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE Abbott Laboratories KPE Class II 1989-12-01
K891493 PATIENT EXAMINATION GLOVES (LATEX) Cinderella Ent. Co., Ltd. LYY Class I 1989-12-01
K896291 INJECTION PORT II --- FOR INTERMITTENT INJECTION The Medi-Dose Group FPA Class II 1989-12-01
K896135 STRAWBERRY SCENTED LATEX EXAMINATION GLOVES Arista Latindo Industrial Ltd. P.T LYY Class I 1989-12-01
K895480 BLUNT NEEDLE PORT/I.V. PORT Applied Medical Technologies FPA Class II 1989-12-01
K895831 NEEDLEPOINT GUARD Needlepoint Guard, Inc. FMF Class II 1989-12-01
K895406 OSBON PERSONAL LUBRICANT Osbon Medical Systems, Ltd. KMJ Class I 1989-12-01
K892584 TON-SU'S VINYL EXAM GLOVES Ton SU Co. , Ltd. LYZ Class I 1989-11-30
K895422 TOWER SELF SEAL STERILIZATION POUCH Baxter Healthcare Corp JOJ Class II 1989-11-29
K894999 LATEX PATIENT EXAMINATION GLOVES Pushpaman Processors, Div. Kanjur Bleaching Co. PV LYY Class I 1989-11-28
K894713 LATEX PATIENT EXAMINATION GLOVES Vailwood Products, L.P. LYY Class I 1989-11-28
K896195 NEEDLE SYRINGE DISPOSAL DEVICE Advanced Medical Components, Inc. MMK Class II 1989-11-27
K893366 LATEX EXAMINATION GLOVES Jinshan Caojing Latex Factory LYY Class I 1989-11-27
K895491 LATEX PATIENT EXAMINATION GLOVES Big Rubber Co., Ltd. LYY Class I 1989-11-27

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