meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
24
Latest Decision
1989-11-24

Clearances · page 115 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K895191 ANTI-THROMBOGENIC COATING FOR CATHETERS Burron Medical, Inc. FOZ Class II 1989-11-24
K895419 DISPOSABLE DISC FILTER The Medi-Dose Group FMF Class II 1989-11-24
K896251 HWA TEH EXAMINATION GLOVES Hwa Teh Industrial Sdn. Bhd. LYY Class I 1989-11-21
K896217 SAS LATEX EXAMINATION GLOVES Sas Rubber Products Co., Ltd. LYY Class I 1989-11-21
K893937 LATEX EXAMINATION GLOVES Sai Latex Private , Ltd. LYY Class I 1989-11-21
K894751 CARIBBEAN LATEX PRODUCTS EXAMINATION GLOVES Caribbean Latex Products, Inc. LYY Class I 1989-11-21
K892892 NET STRETCHER PAD (TM) North East Technology FPP Class I 1989-11-21
K895497 LATEX PATIENT EXAMINATION GLOVE Plymouth , Ltd. LYY Class I 1989-11-21
K895871 LIFEPORT POLYURETHANE CATHETER Strato Medical Corp. LJT Class II 1989-11-17
K891259 MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD Diamond Medical Equipment, Inc. FNM Class II 1989-11-17
K895716 LATEX PATIENT EXAMINATION GLOVES Lizhu Sanitary Materials Factory LYY Class I 1989-11-17
K895557 PATIENT EXAMINATION GLOVES Moeller Chemicals, Inc. LYY Class I 1989-11-17
K890754 SPORVIEW CULTURE MEDIA Spsmedical Supply Corp. FRC Class II 1989-11-17
K893351 LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX) China National Medicines & Health Prod. I/E Corp. LYY Class I 1989-11-17
K895023 LATEX PATIENT EXAMINATION GLOVE Beijing Latex Factory LYY Class I 1989-11-16
K895194 LATEX PATIENT EXAMINATION GLOVES Waterwide Sdn. Bhd. LYY Class I 1989-11-16
K895499 POLY-FLEX LATEX EXAMINATION GLOVES Pacific Delta Medical Supply LYY Class I 1989-11-16
K894497 LATEX EXAMINATION GLOVES (POWDER-FREE/HYPO-ALLER.) Safeskin Corp. LYY Class I 1989-11-16
K895340 ABTEX OR JUTAMAL LATEX EXAMINATION GLOVES Jutamal Industry LYY Class I 1989-11-16
K895227 SKINTEX LATEX EXAMINATION GLOVES Fabrica DE Plasticos Mexicanos Del Sur. S.A. LYY Class I 1989-11-16
K895459 LATEX PATIENT EXAMINATION GLOVES The Emulision Glove Factory of the Thirteenth LYY Class I 1989-11-16
K894367 LEUKOSPORT(TM) ADHESIVE TAPE Beiersdorf, Inc. KGX Class I 1989-11-15
K894954 .22 & 1.2 MICRON IV FILTERS Churchill Medical Systems, Inc. FPB Class II 1989-11-13
K893350 LATEX EXAMINATION GLOVES Pan Africa Exports , Ltd. LYY Class I 1989-11-08
K895804 SHANNON LATEX MEDICAL GLOVES Cashmor Mfg. , Ltd. LYY Class I 1989-11-08
K895220 THE ON-GARD RECAPPER On-Gard Systems, Inc. FMF Class II 1989-11-08
K895552 LATEX EXAMINATION GLOVES Jung Hua Co. LYY Class I 1989-11-08
K894194 LATEX EXAM GLOVES (MFG: CHINA NAT CHEM CONST CORP) Invent Ent. (U.S.A.) Corp. LYY Class I 1989-11-07
K894967 LATEX PATIENT EXAMINATION GLOVES Yan Ling Rubber Products Co. LYY Class I 1989-11-07
K892076 PATIENT EXAMINATION GLOVES (LATEX) M/S Shanghai Knitwear Import & Export Corp. LYY Class I 1989-11-07
K893075 PATIENT EXAMINATION GLOVES Quality Latex Corp. Sdn Bhd LYY Class I 1989-11-07
K892571 PATIENT EXAMINATION GLOVES (LATEX) Sinopac Marketing, Inc. LYY Class I 1989-11-07
K891182 PATIENT EXAMINATION GLOVES Raystar Engineering & Construction Sdn Bhd LYY Class I 1989-11-07
K893804 LATEX EXAMINATION GLOVES S-P Pantec Co., Ltd. LYY Class I 1989-11-07
K891256 PATIENT EXAMINATION GLOVES (LATEX) Raewiks, Inc. LYY Class I 1989-11-03
K892167 PATIENT EXAMINATION GLOVES (LATEX) Raewiks, Inc. LYY Class I 1989-11-03
K895432 SAFE-T-CAP Ausmedics Pty , Ltd. FMI Class II 1989-11-03
K894352 PATIENT EXAMINATION GLOVES Rego Latex Progressive Corp. LYY Class I 1989-11-03
K892561 PATIENT EXAMINATION GLOVES (LATEX) Maxicare Mfg. Corp. LYY Class I 1989-11-03
K894292 BARD LIBERATOR DISPOSABLE INFUSION SYSTEM C.R. Bard, Inc. FRN Class II 1989-11-02
K895819 MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL Medi-Tech, Inc. KMF Class I 1989-11-02
K893546 OPTICALLY CLEAR RADIOPAQUE CATHETER Critikon Company, LLC FOZ Class II 1989-11-01
K891794 DISPOSABLE LATEX EXAMINATION GLOVES Cn Asia Sdn Bhd LYY Class I 1989-10-31
K894449 PATIENT EXAMINATION GLOVES Pascorp Newmarket Sdn. Bhd. LYY Class I 1989-10-31
K895438 S.M.P.U. LATEX EXAMINATION GLOVES P.T. Surya Milani Plastic Utama LYY Class I 1989-10-31
K894552 'MED-TECH' LATEX EXAMINATION GLOVE Med-Tech Rubber & Engineering Industries LYY Class I 1989-10-31
K892163 PATIENT EXAMINATION GLOVES (LATEX) Canada Packers, Inc. LYY Class I 1989-10-31
K893488 PULSATILE PUMP FOR GONADORELIN ACETATE Ortho Pharmaceutical Corp. FRN Class II 1989-10-31
K892769 PATIENT EXAMINATION GLOVES Glw Intl. Corp. LYY Class I 1989-10-31
K891670 HEDY PATIENT EXAMINATION GLOVES (VINYL) Hedd Industry Corp. LYZ Class I 1989-10-31
K892138 PATIENT EXAMINATION GLOVES (LATEX) Shanghai Latex Factory LYY Class I 1989-10-31
K895075 ACCI-GUARD REUSABLE HOLDER Medical Safety Products, Inc. FMI Class II 1989-10-31
K894908 LATEX PATIENT EXAMINATION GLOVES Shanghai Shen Hua Rubber and Plastics Co. , Ltd. LYY Class I 1989-10-27
K894206 INTOPO Acacia, Inc. FMF Class II 1989-10-27
K890204 AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR Stedim, Inc. LHI Class II 1989-10-27
K891671 HEDY PATIENT EXAMINATION GLOVES (LATEX) Hedd Industry Corp. LYY Class I 1989-10-27
K893693 H.U. I.V. DROP COUNTER Li-Lien Corp. FLN Class II 1989-10-27
K890205 AUTOMIX COMPOUNDER Y - ADAPTOR SET Stedim, Inc. LHI Class II 1989-10-27
K895046 REMOTE RESERVOIR ADAPTER CASSETTE W/BAG SPIKE Pharmacia Deltec, Inc. FPA Class II 1989-10-25
K894371 NIPRO SAFELET CATH Pharma-Plast USA, Inc. FOZ Class II 1989-10-25
K890039 KLEEN TEST BASIN SET Kleen Test Products JOL Class II 1989-10-24
K891301 PATIENT EXAMINATION GLOVES (LATEX) Taiping Leasing Corp. Sdn. Bhd. LYY Class I 1989-10-20
K895606 EXUSORB(TM) GEL DRESSING Controlled Therapeutics Corp. KMF Class I 1989-10-19
K895203 EN-TRAP SYRINGE The Medtech Group, Inc. FMF Class II 1989-10-18
K894071 COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE Sara Lee Corp. DWL Class II 1989-10-18
K892313 PATIENT EXAMINATION GLOVES (LATEX) Glove Lines Private , Ltd. LYY Class I 1989-10-13
K894570 UNIVERSAL LIGHT CABLE Expanded Optics, Inc. LDQ 1989-10-13
K895722 CITREX LATEX EXAMINATION GLOVES Pt Citra Latex Lestari LYY Class I 1989-10-13
K895431 JOHNSON & JOHNSON TUBE SECUREMENT DEVICE Johnson & Johnson Patient Care, Inc. KMK Class I 1989-10-13
K895743 LATEX PATIENT EXAMINATION GLOVES Rubbertech Industry Co., Ltd. LYY Class I 1989-10-13
K891160 MIC NON-STERILE LATEX GLOVES Asia Dynamics, Inc. LYY Class I 1989-10-13
K891210 POCKETED WRAPS #3009 A,B,C Pro-Safe Professional Linens, Inc. KCT Class II 1989-10-13
K892311 PATIENT EXAMINATION GLOVES Southern Rubber Industries Co., Ltd. LYY Class I 1989-10-13
K892450 MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS Quinton, Inc. KGX Class I 1989-10-11
K894502 AMMEL PATIENT EXAMINATION GLOVES Mauricio Menconi LYY Class I 1989-10-10
K895705 SHAMROCK SAFETY BLOOD COLLECTION SET Ryan Medical, Inc. FMI Class II 1989-10-10
K893597 HYDRAULIC IV POLE Arthro-Medic, Inc. FOX Class I 1989-10-10
K895481 SHAMROCK SAFETY WINGED INFUSION SET Ryan Medical, Inc. FPA Class II 1989-10-10
K895367 INTRAVENOUS EXTENSION SET Medical Product Specialists FPA Class II 1989-10-06
K894827 AUTOMIX 3+3 COMPOUNDER Baxter Healthcare Corp LHI Class II 1989-10-06
K891315 ATTENUATING SURGICAL GLOVE F & L Medical Products Co. LZC Class I 1989-10-05
K894453 LATEX PATIENT EXAMINATION GLOVES Mittal Meditex Pvt. , Ltd. LYY Class I 1989-10-05
K894321 MODEL 285 INFUSION PUMP 3M Company FRN Class II 1989-10-05
K895332 LATEX EXAMINATION GLOVES Ever Glory Intl., Inc. LYY Class I 1989-10-04
K892996 PATIENT EXAMINATION GLOVES Multiplus Trading , Ltd. LYY Class I 1989-10-04
K894360 MODEL 280 INFUSION PUMP 3M Company FRN Class II 1989-10-04
K892608 PATIENT EXAMINATION GLOVES (LATEX) Grand Design Sdn. Bhd. LYY Class I 1989-10-04
K892998 PATIENT EXAMINATION GLOVES Shen Yunn Plastics Corp. LYY Class I 1989-10-04
K895641 NIL PATIENT EXAMINATION GLOVES United Lion Rubber Industries Sdn. Bhd. LYY Class I 1989-10-04
K894320 MODEL 480 INFUSION PUMP 3M Company FRN Class II 1989-10-04
K894587 MASCOT EXAMINATION GLOVES Mascot, Inc. LYY Class I 1989-10-04
K894677 LATEX EXAMINATION GLOVES Kumpulan Santra (Penang) Sdn. Bhd. LYY Class I 1989-10-04
K892609 PATIENT EXAMINATION GLOVES (LATEX) Commfields (M) Sdn. Bhd. LYY Class I 1989-10-04
K895039 STERILE SALINE - FOR SUCTION CATHETER LUBRICATION Aplicare, Inc. GCX Class II 1989-10-03
K891341 PATIENT EXAMINATION GLOVES (LATEX) A.P. Rubber Co., Ltd. LYY Class I 1989-09-29
K893696 PATIENT EXAM GLOVES(MFG: JIN DING ZAI JIE LATEX GL Double Scores , Ltd. LYY Class I 1989-09-29
K895494 EXCEL LATEX PATIENT EXAMINATION GLOVES Alpha Glove Sdn. Bhd. LYY Class I 1989-09-29
K893726 LATEX GLOVE, EXAMINATION Lixin Hygienical Products Factory Co., Ltd. LYY Class I 1989-09-29
K894374 BLOOD DRAWING NEEDLE Pharma-Plast USA, Inc. FMI Class II 1989-09-28
K892586 PATIENT EXAMINATION GLOVES (LATEX) Modlook Industries , Ltd. LYY Class I 1989-09-28

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