meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
44
Latest Decision
1977-09-06

Clearances · page 156 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K771611 PROTECTOR Richard-Allan Medical Ind., Inc. MMK Class II 1977-09-06
K770933 BIO-SHIELD CSR WRAP Convertors FRG Class II 1977-09-02
K771146 STEOILITY TESTING VESSEL Tower Products, Inc. JOJ Class II 1977-08-26
K771458 INFUSION ACCELERATOR Terumo America, Inc. KZD Class I 1977-08-26
K771519 SPECIALIST ARM & LEG PROTECTOR Johnson & Johnson Professionals, Inc. FMP Class I 1977-08-26
K771463 AERO PULSE ALTERNATING PRES. PUMP Medline Industries, Inc. FNM Class II 1977-08-26
K771387 MONITORING LINES & FLUID ADMIN. Norton Performance Plastics Corp. FPK Class II 1977-08-22
K771362 FLU VEN 0150 Venospital, Inc. FPA Class II 1977-08-22
K771453 FLUID HANDLING DEVICE W/INPUT TUBING Imed Corp. FPA Class II 1977-08-22
K771478 INFUSION PUMP #6202 Roche Medical Electronics, Inc. FRN Class II 1977-08-22
K771359 ALLERGIST PACK SYRINGES Pharmaseal Div., Baxter Healthcare Corp. FMF Class II 1977-08-22
K771498 CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET Travenol Laboratories, S.A. FPB Class II 1977-08-19
K771321 HYDRON BURN BANDAGE Abbott Laboratories KMF Class I 1977-08-03
K771121 EMPTY ADMIXTURE CONTAINERS Medi, Inc. KPE Class II 1977-08-03
K771125 POLYURETHANE PROD. FOR I.V. NEEDLES Devon Industries, Inc. FPX Class I 1977-08-02
K771228 LIFECARE EMPTY CONTAINER Abbott Laboratories KPE Class II 1977-08-02
K771229 STERILIZERS, 3100 SERIES TRIM LINE Castle Co. FLE Class II 1977-08-02
K771348 ECONOWRAP PAPER C.S.R. WRAP Tower Products, Inc. FRG Class II 1977-08-02
K771339 MALE LUER LOCK PLUG American Viggo FPA Class II 1977-08-02
K770983 CATHETER THORACIC, AXIOM Axiom Medical, Inc. JOL Class II 1977-07-29
K770944 INSTATEMP H.I. Silverman, D.Sc. KDP Class II 1977-07-27
K771209 TERUFUSION BLOOD ADMIN. SET Terumo America, Inc. FMI Class II 1977-07-26
K770850 TRAY, BLOOD GAS, ARTERIAL, #4014 Concord Laboratories, Inc. FMF Class II 1977-07-15
K770517 NF DEVICE Rpr, Inc. KPD Class II 1977-07-15
K770849 VOLUMET INFUSION PUMP, MODIFI. OF Sigmamotor, Inc. FRN Class II 1977-07-14
K770851 SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016 Concord Laboratories, Inc. FMF Class II 1977-07-14
K771207 TERUFUSION DONOR SET Terumo America, Inc. FMI Class II 1977-07-14
K770953 MONITOR, AERATION, TEC-TEST Castle Co. FRC Class II 1977-07-14
K770695 MONITOR, BED, TECHNOLICS Technolics, Inc. KMI Class I 1977-07-14
K770852 SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015 Concord Laboratories, Inc. FMF Class II 1977-07-14
K771080 STEAM STERILIZATION INDICATOR Info-Chem FRC Class II 1977-07-14
K771204 SURFLO WINGED INFUSION SET Terumo America, Inc. FPA Class II 1977-07-14
K771070 DRY HEAT STERILIZER Cpac, Inc. KMH Class II 1977-07-14
K771032 POUCHES, PEEL OPEN, BREATHABLE Surgicot, Inc. FRG Class II 1977-07-14
K771132 KENWOOD BIOLOGICAL STEOILIZ. INDICATOR Will Ross Co. FRC Class II 1977-07-14
K771205 HYPODERMIC SYRINGE Terumo America, Inc. FMF Class II 1977-07-14
K771203 DISP. HYPODERMIC NEEDLE Terumo America, Inc. FMI Class II 1977-07-14
K770730 PUMP, INFUSION, DYNATECH/HANDLEY Dynatech Medical Products FRN Class II 1977-07-11
K770797 TRAY, CATHETERIZATION W/FOLEY, STERILE Lukens Corp. FRG Class II 1977-07-11
K770912 TIPROTECTOR Tower Products, Inc. KCT Class II 1977-06-29
K770945 POUCH, TYVEK-POLYMYLON Medical Disposables Intl., Inc. FPK Class II 1977-06-29
K770911 MEDISHIELD JORDON LIFTING FRAME Fraser Sweatman, Inc. FPP Class I 1977-06-27
K771037 THERMOMETER, SINGLE USE, STRIP, TEMPADOT Info-Chem FQZ Class I 1977-06-27
K771038 THERMOMETER, SINGLE USE, STRIP, TEMPADOT Organon, Inc. FQZ Class I 1977-06-27
K770920 THORACIC DRAINAGE SET, ARGYLE DUAL Sherwood Medical Industries GAZ Class II 1977-06-24
K770743 SOLUSET FOR IV FAT EMULSION Abbott Laboratories FPA Class II 1977-06-24
K770498 PRESERVE LUBRICANT CODE NO. 43=4035 Codman & Shurtleff, Inc. KMJ Class I 1977-06-20
K770596 CONNECTORS Abco Dealers, Inc. FPK Class II 1977-06-20
K770916 TYGON PAC-MONITORING LINES & FLUID ADMIN Norton Performance Plastics Corp. FMG Class II 1977-06-17
K770362 TAPE, DERMICEL, CLOTH Johnson & Johnson Professionals, Inc. KGX Class I 1977-06-15
K770843 IV PUMP FILTERSET, UNIVERSAL Abbott Laboratories FPB Class II 1977-06-14
K770703 FILTER UNIT, SINGLE USE Millipore Corp. FPB Class II 1977-06-14
K770958 BANDAGE, UNIPRESS, CLARION Sherwood Medical Industries FQM Class I 1977-06-14
K770863 FLU VEN 0160 Venospital, Inc. FPA Class II 1977-06-14
K770708 TYGON PAC-STOPCOCKS Norton Performance Plastics Corp. FMG Class II 1977-06-08
K770763 BURETTE SET, 2C0132 Travenol Laboratories, S.A. FPA Class II 1977-06-08
K770848 DAILY-WEIGHT Sr Instruments, Inc. FRI Class I 1977-06-08
K770847 PORTA-SCALE Sr Instruments, Inc. FRI Class I 1977-06-08
K770533 BAND-AID BRAND ADHES. BAND.-SHEER STRIPS Johnson & Johnson Professionals, Inc. FPX Class I 1977-06-07
K770707 TYGON PAC-MONITORING LINES & FLUID ADMIN Norton Performance Plastics Corp. FMG Class II 1977-06-03
K770649 VAC-RITE Medical Development Co. KDQ Class II 1977-06-02
K770751 CATHETERS, OVER-THE-NEEDLE Cutter Laboratories, Inc. FOZ Class II 1977-05-26
K770744 IV SET THAT REVERTS TO KVO RATE Abbott Laboratories FPA Class II 1977-05-26
K770583 MEDI-PAK LEMON GLYCEOIN SWABS General Medical Co. KXF Class I 1977-05-26
K770853 STERILE COTTON Stat Medical Corp. FRL Class I 1977-05-23
K770588 COTTON BALL KIT American Hospital Supply Corp. FRL Class I 1977-05-23
K770589 FILTER, INTRAVENOUS W/AUTO AIR VENT Jelco Laboratories FPA Class II 1977-05-23
K770635 PROTECTOR, HEEL & ELBOW Tecnol New Jersey Wound Care, Inc. FMP Class I 1977-05-23
K770595 SUTURE REMOVAL SET Abco Dealers, Inc. JOK Class I 1977-05-23
K770758 INJECTION SYSTEM, MDC I.V. Medical Development Co. KZD Class I 1977-05-20
K770682 STERILIZER, SERIES 3000, MODIFICATION TO Castle Co. FLE Class II 1977-05-20
K770510 CANNULA, INTRAVENOUS, TEFLON Sherwood Medical Industries FOZ Class II 1977-05-10
K770476 EXAM GOWN General Medical Co. FME Class I 1977-05-06
K761255 DIGITAL THERMOMETER Texas Instruments, Inc. FLL Class II 1977-05-04
K770777 THERMOMETER, ELECTRONIC, DIGIMED HOL Elmed, Inc. FLL Class II 1977-05-03
K770486 SHEET KIT, STRETCHER, DISPOSABLE American Hospital Supply Corp. KME Class I 1977-04-29
K770499 PATIENT TURNING AND REPOSITIONING G DEV. Patient Healthguards Corp. FMR Class I 1977-04-29
K770511 CANNULA, INTRAVENOUS, HEPARINIZED Sherwood Medical Industries FOZ Class II 1977-04-29
K770528 NEEDLE, MEMBRANE American Viggo FMI Class II 1977-04-29
K770479 LACERATION KIT American Hospital Supply Corp. FMC Class I 1977-04-29
K770536 STEAM STERILIZER, 3000 Castle Co. FLE Class II 1977-04-29
K770481 SHEAR, PLASTIC HANDLE UTILITY S-475-7 Acme United Corp. JOK Class I 1977-04-29
K770518 PIGGYBACK VENOSET W/0.22 FILTER Abbott Laboratories FPA Class II 1977-04-29
K770409 STERI-STOR TM Research Surgical Systems FRG Class II 1977-04-15
K770425 NEEDLES, STERILE, AIRWAY Pfizer Pharmaceuticals FMI Class II 1977-04-15
K770665 VALVE, PRESSURE, DEMAND Mcgaw Respiratory Therapy CBD Class II 1977-04-15
K770433 Q-TIPS Chesebrough-Pond'S U.S.A. Co. KXF Class I 1977-04-15
K770590 SURGI-KIT Ethox Corp. KCT Class II 1977-04-14
K770514 STERILIZER WRAP C.R. Bard, Inc. FRG Class II 1977-04-07
K770381 ISOLATION KIT American Hospital Supply Corp. LDQ 1977-04-05
K770238 OVERDOSE KIT American Hospital Supply Corp. FMF Class II 1977-04-05
K770361 TRAY, BLOOD GAS, CAT. NO. 4010 Concord Laboratories, Inc. FMF Class II 1977-04-05
K770253 MICROFILTRATION SET MF10 Biotest-Serum-Institut CAK Class II 1977-04-05
K770233 STERILE SUCTION CATHETER W/CONTROL Chesire Laboratories JOL Class II 1977-04-05
K770372 STERILIZER, STEAM, CASTLE 3000 Castle Co. FLE Class II 1977-04-05
K770163 SUTURE CUTTER Concept, Inc. JOK Class I 1977-03-30
K770174 LUER-LOCK EXTENSION SET American Viggo FPK Class II 1977-03-30
K770171 ERIKA I.V. ADMINISTRATION SET Erika, Inc. FPA Class II 1977-03-30
K770181 I.V. CATHETER PLACEMENT UNIT American Viggo FOZ Class II 1977-03-30
K770370 CONVENIENCE TRAY Johannah Medical Services, Inc. FMI Class II 1977-03-16

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