meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
46
Latest Decision
1993-05-11

Clearances · page 102 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K922551 SOLACE POWDER FREE LATEX EXAMINATION GLOVES Wembley Rubber Products (M) Sdn Bhd LYY Class I 1993-05-11
K915514 DENTA SAFE LATEX EXAMINATION GLOVES Dental Care Intl., Inc. LYY Class I 1993-05-07
K925373 THEREX LOW-PROFILE PORT/1.0MM I.D./1.8MM O.D Therex Corp. LJT Class II 1993-05-06
K923957 NASAL CAVITY WOUND DRESSING Smith & Nephew Richards, Inc. KMF Class I 1993-05-05
K925449 REPLACEMENT RECHARGEABLE BATTERY PACK'S Portable Power Systems, Inc. FRN Class II 1993-04-29
K923127 NEEDLE-PRO CARTRIDGE Concord/Portex FMI Class II 1993-04-29
K924669 FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W Ferno FPP Class I 1993-04-29
K921766 OHIO INFANT WARMER SYSTEM Ohmeda Medical FMT Class II 1993-04-23
K920736 IVEX-HP96 EXTENDED LIFE FILTER SET Abbott Laboratories FPB Class II 1993-04-23
K921168 ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 Allen Medical Systems, Inc. KZD Class I 1993-04-21
K925384 ISOPORE(TM) TAPE, MODIFICATION Lectec Corp. KGX Class I 1993-04-21
K923019 PHARMACIA DELTEC WINGED INFUSION SET Pharmacia Deltec, Inc. LJT Class II 1993-04-21
K930225 K-LOK CATHETER SECUREMENT DEVICE K-Lok, Inc. KMK Class I 1993-04-21
K924064 INTERLINK UNIVERSAL VIAL ADAPTER Baxter Healthcare Corp LHI Class II 1993-04-21
K921471 BURNSHIELD TRAUMA DRESSING Levtrade Intl. (Pty) , Ltd. FPY Class I 1993-04-20
K926264 MEDICOTEST SKIN FIX Medicotest, Inc. KGX Class I 1993-04-20
K921899 INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET Baxter Healthcare Corp FPA Class II 1993-04-20
K921470 BURNSHIELD FIRE BLANKET Levtrade Intl. (Pty) , Ltd. FPY Class I 1993-04-20
K926290 BURN SHEET Gam Industries, Inc. FPY Class I 1993-04-20
K930197 KWIK BOARD Astral, Ltd. KMK Class I 1993-04-20
K925949 PEDICRAGT BASSINET Pedicraft, Inc. FMS Class II 1993-04-20
K923662 INGROWN TOENAIL PAD Many Bee Co. KGX Class I 1993-04-20
K925817 HEAD & FOOT END DROP PEDI-CRIB Pedicraft, Inc. FMS Class II 1993-04-20
K923068 AVI MODEL 3100 INFUSION PUMP 3M Health Care, Ltd. FRN Class II 1993-04-20
K925358 DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES Colonial Surgical Supply, Inc. LYY Class I 1993-04-12
K925924 NEAL WRIST CONES Neal & Assoc., Inc. FMQ Class I 1993-04-08
K926044 MPM WET DRESSING (SALINE) Mpm Medical., Inc. KMF Class I 1993-04-08
K923408 WRAPPEL T Standard Textile Co., Inc. FRG Class II 1993-04-08
K920965 STRAIGHT-LINES I.V. ORGANIZER Taylor Bio-Medical, Inc. FRA Class II 1993-04-07
K930342 BECTON DICKINSON ARTERIAL BLOOD GAS KITS Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1993-04-07
K923829 LIFECARE 175 INFUSER -- MODIFICATION Abbott Laboratories FRN Class II 1993-04-07
K922809 GENERAL PROCEDURAL STRETCHERS (P880- P886) Hill-Rom, Inc. FPO Class II 1993-03-31
K920930 MDT/CASTLE 10/90 DUAL LOAD STATION Mdt Corp., Inc. FLF Class II 1993-03-31
K926411 SAF-LIFT/SAF-KARY Arjo-Century, Inc. FNG Class II 1993-03-31
K922808 HILL-ROM VIA STRETCHER (P1300 - P1303) Hill-Rom, Inc. FPO Class II 1993-03-31
K920638 BIO-MATE PIC CATHETER Medevice, Inc. FOZ Class II 1993-03-26
K922214 EMPTY VIAFLEX PLASTIC CONTAINER Baxter Healthcare Corp KPE Class II 1993-03-26
K922533 IV START KIT CUSTOM SMP # A-Z Specialty Medical Products Co. LRS Class II 1993-03-23
K924577 MEDIVAC Medisonic U.S.A., Inc. GCX Class II 1993-03-23
K922896 VITAL-PORT VASCULAR ACCESS SYSTEM W/ INJECTROL Med Institute, Inc. LJT Class II 1993-03-20
K926011 A-PORT IMPLANT VASCU ACCESS SYST PROD LIN EXT-MODI Therex Corp. LJT Class II 1993-03-19
K924297 DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER Air-Shields Vickers, Inc. FMZ Class II 1993-03-18
K921761 SHAWNEE PRODUCTS KIT II Absentee Shawnee Bandage Group KGX Class I 1993-03-18
K924070 B-D PEN NEEDLE Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1993-03-18
K925376 COMFEEL(R) WOUND DRESSING SD Coloplast A/S KMF Class I 1993-03-16
K924180 I.V. PRO I.V. - Pro Tek, Inc. KMK Class I 1993-03-16
K926118 LIFE TRACE(R) BILIRUBIN MASK Graphic Controls Corp. FOK Class I 1993-03-15
K924265 DOCTOR'S CHOICE LATEX EXAMINATION GLOVES Chesire Laboratories LYY Class I 1993-03-15
K922469 PRO-LOK EXTENSION SET(S) Vlv Associates, Inc. FPA Class II 1993-03-15
K924233 SAVACARE LATEX EXAMINATION GLOVES Preventive Care, Inc. LYY Class I 1993-03-12
K913766 ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES Ansell, Inc. LYY Class I 1993-03-11
K921190 ADAP-TEMP TEMPERATURE SENSOR ADAPTER Respiratory Support Products, Inc. FLL Class II 1993-03-09
K922817 PM3000 & PM3100 VACUUM REGULATOR Precision Medical, Inc. KDP Class II 1993-03-04
K915607 PATIENT EXAMINATION GLOVES Seal Polymer Industries Bhd. LYY Class I 1993-03-04
K922282 ILLUMINATOR VIII ULTRA/SPOT Medical Illumination, Inc. KZF Class I 1993-03-04
K922278 ILLUMINATOR III Medical Illumination, Inc. KZF Class I 1993-03-04
K924959 STERLING LATEX EXAM GLOVE, HYPO-ALLERGENIC Perlink USA, Inc. LYY Class I 1993-03-03
K925401 IV FLUID TRANSFER PIN B. Braun of America, Inc. LHI Class II 1993-03-03
K926007 ACCESSORY TO PISTON SYRINGE Martech Medical Products, Inc. FMF Class II 1993-02-23
K915574 COMFORT PERSONAL LUBRICANT Hyman, Phelps & McNamara, P.C. KMJ Class I 1993-02-19
K922903 HYGIENEX EXAMINATION GLOVES Hygienex Corp. LYY Class I 1993-02-18
K926013 SPORICIDIN BRAND DISINFECT TOWEL, SPRAY/SOLUT MODI Sporicidin Intl. LRJ Class I 1993-02-12
K924439 BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA Bd Becton Dickinson Vacutainer Systems Preanalytic FMI Class II 1993-02-12
K924266 DOCTOR'S CHOICE POWDER FREE LATEX EXAM GLOVES Chesire Laboratories LYY Class I 1993-02-10
K924419 CIR LATEX GLOVES Crocker Industrial Resources Sdn. Bhd. LYY Class I 1993-02-10
K924807 REUSABLE INCONTIENT UNDERPAD Perfect Fit Industries, Inc. FMW Class I 1993-02-10
K923862 LATEX PATIENT EXAMINATION GLOVE (POWDER FREE) Siam Sempermed Corp., Ltd. LYY Class I 1993-02-10
K922280 ILLUMINATOR VII MINI/LUM LIGHT Medical Illumination, Inc. KZF Class I 1993-02-05
K922382 INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE Baxter Healthcare Corp MEB Class II 1993-02-05
K924170 ISOLETTE INCUBATOR HUMIDITY METER Air-Shields, Inc. FMZ Class II 1993-02-05
K922281 ILLUMINATOR VII MINI/SPOT LIGHT Medical Illumination, Inc. KZF Class I 1993-02-05
K922277 ILLUMINATOR II Medical Illumination, Inc. KZF Class I 1993-02-05
K924369 ILS(TM) - INVASIVE LINE SEPARATOR 2-Rn Corp. KMK Class I 1993-02-05
K921450 NON-INVASIVE TUBING Specialty Medical Sales, Inc. FPK Class II 1993-02-05
K925412 ELECTROMEDICS TISSUE TRAP/ #TT280 Electromedics, Inc. BYZ Class II 1993-02-05
K924249 DERMASSIST TRANSPARENT SITE DRESSING Wilshire Medical Products KMK Class I 1993-02-03
K922119 MODEL 5002 LIFT WEIGH-SCALE Acme Medical Scale Co. FRW Class I 1993-02-03
K915157 POWDER FREE EXAMINATION GLOVE American Pro Latex, Inc. LYY Class I 1993-02-02
K922083 RMI SURGICCAL SITE VISUALIZATION WAND Research Medical, Inc. FQH Class II 1993-01-29
K915824 HOLE PUNCH American Biomaterials Corp. FOZ Class II 1993-01-29
K921613 STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510 Dept. of the Army FLE Class II 1993-01-29
K924477 WIPEABLE PILLOW Perfect Fit Industries, Inc. FMW Class I 1993-01-29
K925532 POWDER FREE EXAMINATION GLOVES Mbf Health Products Bhd. Sdn. LYY Class I 1993-01-29
K921955 QUIK FLOW California Medical Equipment, Inc. FOZ Class II 1993-01-29
K915780 RACK AND SYRINGES Normeca Corp. FMF Class II 1993-01-27
K922968 VINYL EXAM GLOVES Normandin Pacific Holdings Corp. LYZ Class I 1993-01-27
K924633 HYPOALLERGENIC LATEX GLOVES Pan-Century Rubber Products Sdn. Bhd. LYY Class I 1993-01-27
K922786 THERM O DRUG MODEL HT-747 C.F. Electronics, Inc. LGZ Class II 1993-01-27
K915306 THE KAUFMANN LIFT-AND-TURN MATTRESS Kaufmann Sjukvardsartiklar FNM Class II 1993-01-27
K922074 DCR VOLUMETRIC INFUSION PUMP W/ NEW MAINS POWER PK Danby Medical , Ltd. FRN Class II 1993-01-22
K915251 PATIENT EXAMINATION LATEX GLOVES, HYPOALLERGENIC Supermax Sdn Bhd LYY Class I 1993-01-22
K923577 BREAST SHELLS Medela, Inc. HFS Class I 1993-01-22
K920637 PRIME PCA AND PCA/CONTINUOUS SYSTEMS Prime Medical Products, Inc. MEA Class II 1993-01-15
K923981 IVAC SYRINGE PUMP - 740 SERIES Y FRN Class II 1993-01-15
K923358 LC STRIP Genetic Laboratories Wound Care, Inc. KGX Class I 1993-01-13
K925502 TRACE MODEL# 840, 841,842 & 845 ARM BOARD Trace Medical Equipment, Inc. KMK Class I 1993-01-12
K925001 CURITY CALCIUM ALGINATE WOUND DRESSING Kendall Healthcare Products Co. Div.Of Tyco Health KMF Class I 1993-01-11
K921347 CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER Medi-Flex Hospital Products, Inc. MCY Class II 1993-01-08
K921327 NATURE'S CRADLE HM-10 Infant Advantage, Inc. FMS Class II 1992-12-29
K922845 BASIC DRESSING CHANGE TRAY SMP 102A Specialty Medical Products Co. FRG Class II 1992-12-29

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