meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
30
Latest Decision
1995-05-03

Clearances · page 91 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K945845 MICOS MICROPULSE(TM) OR TABLE PATIENT SUPPORT Micos Medical Systems FNM Class II 1995-05-03
K940951 RW RESUCITAIRE INFANT RADIANT WARMER Air-Shields, Inc. FMT Class II 1995-05-03
K942784 NORFOLK OMEGA PORT-LP SUBCUTANEOUSLY IMPLANTED Norfolk Medical Products, Inc. LJT Class II 1995-05-02
K934066 NEPHRETECT Alden Scientific, Inc. JOJ Class II 1995-05-02
K944692 C-SERIES HOMEPUMP Block Medical, Inc. FPA Class II 1995-05-02
K946250 STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS Strato Medical Corp. LJS Class II 1995-05-02
K936040 HYPO(R) SAFETY CARTRIDGE SYRINGE Smith & Nephew, Inc. MEG Class II 1995-05-01
K951468 COMFIT Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-04-28
K951327 COMFEEL PLUS CONTOUR DRESSING Richard Hamer Assoc., Inc. KMF Class I 1995-04-28
K951455 SCIPOTEX (PINK) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-04-28
K943692 SMART DOSE(TM) River Medical, Inc. FRN Class II 1995-04-28
K945785 SCIPOTEX Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-04-28
K951456 SCIPOTEX (BLUE) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-04-28
K951467 ULTIMAX Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-04-28
K942159 NOVOPEN 1.5 Novo Nordisk Pharmaceuticals, Inc. FMF Class II 1995-04-26
K950367 IV SHUTTLE Equipment Concepts, Inc. FOX Class I 1995-04-26
K946111 PROSHIELD PLUS MULTIPLE Sino (U.S.A.) Co. LYY Class I 1995-04-25
K950619 BIODERM MEDICAL FOAM WOUND DRESSING Bioderm, Inc. KMF Class I 1995-04-25
K950467 POWDER FREE PATIENT EXAMINATION GLOVES Intl. Trade Management Co. LYY Class I 1995-04-25
K951317 PHENO-CEN SPRAY DISINFECTANT DEODORANT Central Solutions, Inc. LRJ Class I 1995-04-25
K950464 SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES Sscor GCX Class II 1995-04-25
K951342 Q4.5-5.0PB-4.5 Central Solutions, Inc. LRJ Class I 1995-04-25
K951123 CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER Micro-Aseptic Products, Inc. LRJ Class I 1995-04-25
K925056 SAFESHARPE (TM) DISPOSAL SYSTEM Life Medical Technologies, Inc. FMI Class II 1995-04-21
K943695 SURETEMP Advanced Bioresearch Assoc. FLL Class II 1995-04-21
K945551 CELSITE(TM) DUAL VENOUS SYSTEM B. Braun of America, Inc. LJT Class II 1995-04-21
K940382 LYSOL I.C. BRAND DISINFECTANT National Laboratories LRJ Class I 1995-04-21
K950341 BARNARD & ASSOCIATES REMANUFACTURED GENERAL PURPOSE, VACUUM OR LABORATORY STERILIZER Barnard and Assoc. FLE Class II 1995-04-19
K934874 STERIGAGE EO 100% Pymah Corp. JOJ Class II 1995-04-18
K950301 ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS Becton Dickinson Vascular Access, Inc. FOZ Class II 1995-04-18
K946201 STAND, INFUSION Medical Specialties, Inc. FOX Class I 1995-04-18
K951499 DERMAGRAN HYDROPHILIC OINTMENT Derma Sciences, Inc. KMF Class I 1995-04-18
K945629 MICOS MICROPULSE(TM) ALTERNATING PRESSURE MATTRESS Micos Medical Systems FNM Class II 1995-04-14
K950159 SURESHARP Gainor Medical U.S.A., Inc. FMI Class II 1995-04-14
K936266 COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-04-13
K950212 A2 DETACHED DUAL PORT SYSTEM Therex Corp. LJT Class II 1995-04-13
K935466 CLINICAL VOICE THERMOMETER Blazie Engineering, Inc. FLL Class II 1995-04-13
K951137 COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC) Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-04-13
K951171 SCIPOTEX Wembley Rubber Products (M) Sdn Bhd LYY Class I 1995-04-13
K950677 ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN Atrium Medical Corp. KDQ Class II 1995-04-13
K950133 HYPODERMIC SYRINGE PISTON Ispg, Inc. FMF Class II 1995-04-13
K946245 TIELLE* HYDROPOLYMER DRESSING Johnson & Johnson International KMF Class I 1995-04-11
K945825 SECURE SAFETY INSERT Syncor Intl. Corp. FMI Class II 1995-04-10
K943038 STATLOCK-IPIDURAL Venetec, Inc. FPA Class II 1995-04-10
K943770 LOW VOLUME MULTIPORT B. Braun of America, Inc. FPA Class II 1995-04-10
K944302 THE FLEX-SET SUBCUTANEOUS INFUSION SET Cathco, Inc. FOZ Class II 1995-04-10
K943661 STERILE PHYSIOLOGICAL SALINE/STERILE WATER Medcare Custom Packaging, Inc. JOL Class II 1995-04-10
K945521 CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY Menlo Care, Inc. FOZ Class II 1995-04-06
K944367 CATCO POLYURETHANE UMBILICAL VESSEL CATHETER Catco Medical, Inc. FOZ Class II 1995-04-05
K944410 CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER Catco Medical, Inc. FOZ Class II 1995-04-05
K944368 CATCO SILICONE UMBILICAL VESSEL CATHETER Catco Medical, Inc. FOZ Class II 1995-04-05
K944336 CATCO UMBILICAL VESSEL CATHETER Catco Medical, Inc. FOZ Class II 1995-04-05
K950033 POLYDERM Wilshire Technologies LZA Class I 1995-04-04
K950775 CURASORB ZN ALGINATE WOUND DRESSING Kendall Healthcare Products Co. Div.Of Tyco Health KMF Class I 1995-04-03
K945224 GRX FOAM DRESSING Geritrex Corp. KMF Class I 1995-04-03
K950254 CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE Cypress Medical Products, Ltd. LYY Class I 1995-03-31
K926364 ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X 3M Health Care, Ltd. FRC Class II 1995-03-31
K944685 CATO FIRST PICC-DUAL LUMEN Catco Medical, Inc. LJS Class II 1995-03-31
K944873 TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES Baxter Healthcare Corp LYZ Class I 1995-03-31
K944504 CATCO FIRST PICC Catco Medical, Inc. FOZ Class II 1995-03-31
K944968 LANDMARK MIDLINE CATHETER Menlo Care, Inc. FOZ Class II 1995-03-29
K944824 SUREWING Gainor Medical U.S.A., Inc. FPA Class II 1995-03-29
K950737 LANDMARK MIDLINE CATHETER Menlo Care, Inc. FOZ Class II 1995-03-29
K942483 CLINICAL GLASS THERMOMETER Makol Medical Instruments Corp. FLK Class II 1995-03-28
K942931 STATLOCK SECUREMENT DEVICES Venetec, Inc. FPA Class II 1995-03-28
K950200 IVID Scott/Ross Designs, Inc. FPK Class II 1995-03-24
K946078 HOSPITAL BROAD BAND CLEANDR - DISINFECTANT-DEODORANT Clariant Corporation LRJ Class I 1995-03-24
K944293 SABRATEK SABSIL SETS Sabratek Corp. FPA Class II 1995-03-23
K950131 1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL Therex Corp. LJT Class II 1995-03-23
K945227 OCIDE HOSPITAL CLEANER-DISINFECTANT Clariant Corporation LRJ Class I 1995-03-23
K945885 PATIENT EXAMINATION GLOVES Hartalega Sdn Bhd LYY Class I 1995-03-23
K943349 MAHURKAR DUAL LUMEN CATHETER Quinton, Inc. FOZ Class II 1995-03-22
K943658 CHEMOTHERAPY WASTE DISPOSAL CONTAINERS Sage Products, Inc. MMK Class II 1995-03-22
K943660 PHLEBOTOMY SHARPS DISPOSAL CONTAINERS Sage Products, Inc. MMK Class II 1995-03-22
K950766 SIGMA 8000 AND SIGMA 8002 Sigma Intl. General Medical Apparatus, Inc. FRN Class II 1995-03-22
K943659 ANCILLARY AND LARGE VOLUME SHARPS DISPOSAL CONTAINERS Sage Products, Inc. MMK Class II 1995-03-22
K944179 CONTROL III DISINFECTANT GERMICIDE Maril Products, Inc. LRJ Class I 1995-03-22
K950324 MULTI-WASH Multi-Wash Medical, Ltd. LRJ Class I 1995-03-22
K950516 COLDCIDE-10 Metrex Research Corp. LRJ Class I 1995-03-22
K944037 DIACIDE HD DISINFECTING SOLUTION Gulfstream Medical LRJ Class I 1995-03-22
K950553 COLDCIDE-2 Metrex Research Corp. LRJ Class I 1995-03-22
K940383 LYSOL I.C. BRAND INSTRUMENT DISINFECTANT PRESOAK National Laboratories LRJ Class I 1995-03-22
K930884 MEDICAL PROCEDURE TRAY, MODIFICATION Enpak Medical Corp. LDQ 1995-03-21
K946019 SURGICLA INSTRUMENT KIT Medical Action Industries, Inc. FRG Class II 1995-03-20
K946190 DRUG DISPENSING SPIKE Gelman Sciences, Inc. FMF Class II 1995-03-17
K944580 FLEXSYS MOBILEMATE EQUIPMENT STAND Hill-Rom, Inc. FOX Class I 1995-03-17
K944310 PEGASUS BIWAVE PLUS SYSTEM Pegasus Airwave, Inc. FNM Class II 1995-03-17
K945041 PARAGON PORTABLE Pegabus Egerton, Ltd. FNM Class II 1995-03-16
K945042 ELITE 3 LOW AIR LOSS BED Pegabus Egerton, Ltd. FNL Class II 1995-03-16
K943992 SILCLEAR TUBING Degania Silicone , Ltd. FPK Class II 1995-03-16
K945809 MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT) Sherwood Medical Co. FMI Class II 1995-03-15
K950184 B. BRAUN IV START KITS B. Braun of America, Inc. LRS Class II 1995-03-15
K950438 SAFEDWEEL DRESSING CHANGE TRAY Becton Dickinson Vascular Access, Inc. FRG Class II 1995-03-15
K950850 GENT-L-KARE LACERATION TRAYS Premium Plastics, Inc. FRG Class II 1995-03-14
K946208 VOLKER NURSING BED MODEL 2080E & 2090E Volker Healthcare, Inc. FNL Class II 1995-03-14
K946149 STRYKER AGILITY INTENSIVE CARE BED Stryker Medical FNL Class II 1995-03-14
K950304 DESERET (R) T-PORT (R) MULTI FLO(TM) AND DESERET (R)PRN ADAPTER Becton Dickinson Vascular Access, Inc. FPA Class II 1995-03-14
K950303 DESERET(R) I.V. LOOP AND DESERET (R) J LOOP Becton Dickinson Vascular Access, Inc. FPA Class II 1995-03-14
K944511 ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC) Neostar Medical Technologies, Inc. FOZ Class II 1995-03-13
K946082 BEECH PRO LOK FIXED Beech Medical Products, Inc. FPA Class II 1995-03-13

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