meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
56
Latest Decision
1977-03-16

Clearances · page 157 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K770422 CATHETER, SURFLO, I.V. Terumo America, Inc. FOX Class I 1977-03-16
K770353 DISPOSABLE TEMPERATURE PROBE Inhal-O-Tech Medical Plastic KPD Class II 1977-03-16
K770403 CATHETER-THRU-NEEDLE DEVICE Abbott Laboratories FOZ Class II 1977-03-16
K770182 0.22/UM FILTERSET W/Y-INJECTION SITE Abbott Laboratories FPB Class II 1977-03-15
K770119 I.V. LOK TM Jelco Laboratories KMK Class I 1977-03-14
K770125 DISPOS-A-CARE THERMOMETER SHEATH Chesebrough-Pond'S U.S.A. Co. FLK Class II 1977-03-14
K770108 TUBE HOLDING DEVICE Pharmaseal Div., Baxter Healthcare Corp. FPK Class II 1977-03-10
K770081 BAND-AID BRAND OF ADHESIVE BANDAGES Johnson & Johnson Professionals, Inc. FPX Class I 1977-03-09
K770369 VACON TM Diemolding Corp. CBD Class II 1977-03-01
K761192 DRESSING CHANGE KIT Superior Plastic Products Corp. JOK Class I 1977-02-28
K761341 PORTAGAS AERATOR Amsco Co. FLI Class II 1977-02-28
K770078 CASTLE TEC-TEST STEAM STERI. INTEGRATOR Castle Co. JOJ Class II 1977-02-28
K770339 BANDAGE, PLASTIC & SHEER Johnson & Johnson Professionals, Inc. FPX Class I 1977-02-28
K761268 SKIN PRESSURE PROTECTORS Mark One Healthcare Products FMP Class I 1977-02-16
K770180 SUB. OF DIACETONE ACRYLAMIDE Johnson & Johnson Professionals, Inc. FPX Class I 1977-02-15
K770087 I.V. PUMP, ABBOTT/SHAW LIFECARE Abbott Laboratories FRN Class II 1977-02-14
K770162 MATERNITY SUPPORTER R.G. Moore FSD Class I 1977-02-09
K770183 O.22/UM FILTERSET W/FLASHBACK Abbott Laboratories FPB Class II 1977-02-09
K770051 VENOSET FOR I.V. FAT EMULSION Abbott Laboratories FPA Class II 1977-02-08
K761327 IV SETS 2000 SERIES (HS-200,2L0,220) Extracorporeal Medical Specialities, Inc. FPA Class II 1977-01-31
K761098 FILTER DEVICES Arrow Intl., Inc. FMI Class II 1977-01-28
K761147 RELIANCE MOD-U-LINE M-700 F. & F. Koenigkramer FPO Class II 1977-01-28
K761099 DOVER HYPERALIMENTATION DRESSING CHNG KT Will Ross Co. FRL Class I 1977-01-28
K770120 MOUTH WASH TRAY Pharmaseal Div., Baxter Healthcare Corp. FMA Class I 1977-01-28
K761158 FLUID DISPENSING SYSTEM Pharmaseal Div., Baxter Healthcare Corp. FMF Class II 1977-01-26
K760966 CATHETER, UMBILICAL ARTERY Sherwood Medical Industries FOS Class II 1977-01-26
K760972 TYCOS DIAGNOSTIC PENLIGHT Taylor Instrument Analytics Co. KYT Class I 1977-01-26
K761032 CRADLING SYSTEM Medin Corp. FLE Class II 1977-01-26
K761015 MARKET CASTLE UNISPHERE Castle Co. FRC Class II 1977-01-21
K761307 AUTO SYRINGE MODEL AS-3A Baxter Healthcare Corp FRN Class II 1977-01-06
K761336 BAND-AID BRAND PLASTIC BANDAGES Johnson & Johnson Professionals, Inc. KGX Class I 1977-01-05
K760931 I.V. DRIP MONITOR ALARM DEVICE, MONIFLO Diemolding Corp. FLN Class II 1977-01-05
K761335 BAND-AID BRAND SHEER BANDAGES Johnson & Johnson Professionals, Inc. KGX Class I 1977-01-05
K760951 DEVON COOL FACE Devon Industries, Inc. KYR Class I 1976-12-30
K760954 CROWNTEX EXAM. CAPE & GOWN Graham Manufacturing Co. FME Class I 1976-12-30
K760699 MULTI-TEST Lincoln Laboratories, Inc. SCL Class II 1976-12-30
K760880 ADDITIVE CAP (2B8905) Travenol Laboratories, S.A. KPE Class II 1976-12-30
K760662 STERIL.WRAP(#221901,2,3,4,5,6,7,8,9) C.R. Bard, Inc. FRG Class II 1976-12-30
K760921 AIR PURIFIER Vitaire Corp. FRF Class II 1976-12-29
K761244 SERIES 700 PATIENT MONITORS Spacelabs, Inc. FLL Class II 1976-12-23
K760694 ARNCO I.V. MONITOR A.R. Nelson Co., Inc. FLN Class II 1976-12-23
K760879 ROOM AIR PURIFIER (TEX-DYN) Texas Dynamics FRF Class II 1976-12-16
K761079 FLEXIBLE TIP ASPIRATING TUBES Pilling Co. BYY Class II 1976-12-09
K760895 AUTOMATIC SHUT-OFF VALVE Delta Medical Industries KZD Class I 1976-12-09
K761202 AQUA-SEAL Respiratory Care, Inc. KDQ Class II 1976-12-09
K760948 THERMO FINER CORETEMP Terumo America, Inc. FLL Class II 1976-12-09
K761151 INFUSION PUMP Travenol Laboratories, S.A. FRN Class II 1976-12-09
K761012 ALPHABED ALTERNATING PRESSURE PAD Nlowtron-Aire , Ltd. FNM Class II 1976-12-09
K760876 ARGYLE IV STARTER KIT (W/O DRUG) Sherwood Medical Industries LRS Class II 1976-12-09
K761011 CASTLE TEC-TEST AERATION MONITOR Castle Co. JOJ Class II 1976-12-02
K760678 4-WAY STOPCOCK W/100 CM TUBING, LUER-LK American Viggo FMG Class II 1976-12-02
K761109 TERRYCLOTH BIBS Fred Sammons, Inc. KME Class I 1976-12-02
K760679 4-WAY STOPCOCK W/7CM TUBING, American Viggo FMG Class II 1976-12-02
K761108 PLASTIC DISPOSABLE BIB Fred Sammons, Inc. KME Class I 1976-12-02
K761110 BED TRAY Fred Sammons, Inc. KMN Class I 1976-12-02
K760661 STERILIZER WRAP (CAT#221831,2,3,4,5,6) C.R. Bard, Inc. FRG Class II 1976-12-02
K760667 4-WAY STOPCOCK W/10 CM EXTEN. TUBING American Viggo FMG Class II 1976-12-02
K760666 4-WAY STOPCOCK W/LUER-LOCK FITTING American Viggo FMG Class II 1976-12-02
K760758 STERILIZATION PACKAGING MATERIALS Paper Manufacturers Co. FRG Class II 1976-12-02
K760720 MON-A-THERM TEMPARATURE MONITOR SYS Labarge, Inc. FLL Class II 1976-11-30
K760618 PATIENT RESTRAINT Encompass Group, LLC FMQ Class I 1976-11-24
K760963 DECUBITUS MATTRESS Arco Medical Products Co. IKY Class I 1976-11-18
K760780 DOUBLE-ENDED NEEDLE Travenol Laboratories, S.A. FMI Class II 1976-11-16
K760494 BASIN, ROUND WASH Landmark Plastics FNY Class I 1976-11-12
K760552 THERMOMETER STAND AND DUST COVER Landmark Plastics FLK Class II 1976-11-12
K760490 BEDPAN, GENERAL MEDICAL MEDI-PAK Landmark Plastics FOB Class I 1976-11-12
K760517 CUP, DISPOSABLE MEDICINE Landmark Plastics KYX Class I 1976-11-12
K760545 WEIGHING STATION, MOBILE PATIENT Gaymar Industries, Inc. FRW Class I 1976-11-12
K760586 SUCTION KIT Bd Becton Dickinson Vacutainer Systems Preanalytic JOL Class II 1976-11-12
K760492 BASIN, LARGE OR SMALL Landmark Plastics FNY Class I 1976-11-12
K760495 BASIN, RECTANGULAR WASH Landmark Plastics FNY Class I 1976-11-12
K760733 SKIN STAPLE EXTRACTOR ETHICON, Inc. GAG Class II 1976-11-03
K760732 SKIN STAPLING INSTRUMENT ETHICON, Inc. GAG Class II 1976-11-03
K760814 HEPARINIZED PENROSE TUBING Sherwood Medical Industries GCX Class II 1976-11-03
K760772 DISPOSABLE ABDOMINAL BINDER Tecnol New Jersey Wound Care, Inc. FSD Class I 1976-11-03
K760812 HEPARINIZED WOUND SUCTION TUBING Sherwood Medical Industries GCX Class II 1976-11-03
K760813 HEPARINIZED SARATOGA SUMP DRAIN Sherwood Medical Industries GCX Class II 1976-11-03
K760392 SYRINGES B. Braun Instruments FMF Class II 1976-11-02
K760872 PHOTOTHERAPY LIGHT Air-Shields, Inc. LBI Class II 1976-11-02
K760870 HEEL/ELBOW FLOTATION CUSHION Medpro, Inc. FMP Class I 1976-11-01
K760333 JAR, COLLECTOR FOR SUCTION SYSTEMS Harris-Lake, Inc. GCX Class II 1976-10-27
K760360 SHIRT, MITTEN CUFF INFANT Precept, Inc. FME Class I 1976-10-20
K760718 PERISTALTIC INFUSION PUMP (2100,2101) Extracorporeal Medical Specialities, Inc. FRN Class II 1976-10-14
K760320 PROTECTOR, SURGICAL INSTRUMENT Devon Industries, Inc. KCT Class II 1976-09-30
K760683 ALARM, THERMAL, THERM-ALERT Respiratory Care, Inc. KPD Class II 1976-09-27
K760491 TUMBLER, GENERAL MEDICAL MEDI-PAK Landmark Plastics LDR Class II 1976-09-15
K760481 FILTER, PARTICULATE ARRESTING Miles Laboratories, Inc. FRF Class II 1976-09-15
K760505 SOLUTION ADMINISTRATION SET (#2C0631) Travenol Laboratories, S.A. KZD Class I 1976-09-03
K760483 BLOOD-SOLUTION ADMINISTRATION SET, SURG. Travenol Laboratories, S.A. KZD Class I 1976-09-03
K760393 BED PAN, STACKABLE (AUTOCLAVABLE) Bemis Health Care FOB Class I 1976-08-23
K760217 SUCTION INSTRUMENT, MACBICK DIS. FRAZ. C.R. Bard, Inc. GCX Class II 1976-08-23
K760216 SUCTION INSTRUMENT, MACBICK POOLE TIP C.R. Bard, Inc. GCX Class II 1976-08-23
K760370 INFUSION EQUIPMENT, INTRAVENOUS Valleylab, Inc. FRN Class II 1976-08-23
K760005 SYRINGE, DISPOSABLE, GLASS & PLASTIC Stewart-Naumann Laboratories FMF Class II 1976-08-23
K760421 THERMOMETER, SURVALENT-ELECTRONIC Arbrook Mfg. Corp. FLL Class II 1976-08-23
K760004 SYRINGE, DISPOSABLE, ALL PLASTIC Stewart-Naumann Laboratories FMF Class II 1976-08-23
K760319 KIT, CATHETER Jelco Laboratories FOZ Class II 1976-08-11
K760342 RAZOR, SCHICK DISPOSABLE Parke-Davis Co. LDQ 1976-08-11
K760365 BLANKET, BURN Winn Hirsch & Assoc. FPY Class I 1976-08-11
K760328 RAZOR, DISPOSABLE Devon Industries, Inc. LDQ 1976-08-11

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