meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
41
Latest Decision
1981-06-16

Clearances · page 149 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K811269 GLASS VIALS Medi-Plast Intl., Inc. KPE Class II 1981-06-16
K811463 AUTO-SYRINGE MICRO VOLUME EXTENSION SET Baxter Healthcare Corp FPA Class II 1981-06-12
K810795 INSTAFIL Instafil, Inc. KPE Class II 1981-06-12
K811446 HYDRON WOUND DRESSING KIT National Patent Development Corp. KMF Class I 1981-06-12
K811247 CATHETER MAINTENANCE KIT Clinipad Corp. FRG Class II 1981-06-12
K811009 PREFILLED PULSATOR SYRINGE Concord Laboratories, Inc. FMF Class II 1981-06-12
K811107 IV SETS Critikon Company, LLC FPA Class II 1981-06-12
K811408 STERILIZATION INDICATOR/SEAL PROTECTOR Beacon Converters, Inc. JOJ Class II 1981-06-12
K811110 MODELS: 52-01-0, 52-01-1 Y FPA Class II 1981-06-11
K803183 OFFENBACK REVERSIBLE BARIUM PUMP The Offenback Co. FRN Class II 1981-06-09
K811238 MODEL 560 SERIES VOLUMETRIC INFUSION Y FRN Class II 1981-06-02
K811006 SOLUTION ADMINISTRATION SET Suru Chemicals & Pharmaceuticals, Ltd. FPA Class II 1981-06-02
K811291 TEGADERM TRANSPARENT DRESSING 3M Company KGX Class I 1981-06-02
K811192 VAC-RITE SUNCTION COLLECTION Bd Becton Dickinson Vacutainer Systems Preanalytic KDQ Class II 1981-06-02
K810469 STERILEDGE SELF SEAL POUCH Beacon Converters, Inc. KCT Class II 1981-06-01
K810239 VENTED PRIMARY PIGGYBACK VENOSET DUAL Abbott Laboratories FPA Class II 1981-05-29
K811030 APPOSE SKIN STAPLER Davis & Geck, Inc. GAG Class II 1981-05-27
K811171 VASCULON II I.V. CATHETER Pioneer Viggo, Inc. FOZ Class II 1981-05-27
K810317 NITROGLYCERINE IV SET Abbott Laboratories FPA Class II 1981-05-27
K811167 FOCUS STERILE SYRINGES Stanford Laboratories FMF Class II 1981-05-21
K811242 DISPOSABLE STERILIZATION WRAP Amsco Co. FRG Class II 1981-05-21
K811232 DISPOSABLE UNDERPADS Burina KME Class I 1981-05-21
K810995 PREFILLED PULSATOR SYRINGE Concord Laboratories, Inc. FMF Class II 1981-05-21
K803249 FLUID WARMER Datachem, Inc. LGZ Class II 1981-05-21
K810918 ROLL-A-SET Principle Business Ent. FRG Class II 1981-05-21
K810921 MALE LUER LOCK PLUGS Procedure Products, Inc. FPA Class II 1981-05-21
K811184 SPENCO DERMAL PADS Spenco Medical Corp. FMP Class I 1981-05-20
K810868 ARALUEN HEAD SHIELD Araluen, Inc. FPP Class I 1981-05-13
K811088 DRESSING TRAY MERCY HOSPITAL Cunningham Woodland, Inc. LDQ 1981-05-08
K811091 MINOR DRESSING TRAY Cunningham Woodland, Inc. LDQ 1981-05-08
K811089 ONE STEP PREP KIT Cunningham Woodland, Inc. LDQ 1981-05-08
K811090 MAJOR DRESSING TRAY Cunningham Woodland, Inc. LDQ 1981-05-08
K811065 PISTON SYRINGE Sherwood Medical Co. FMF Class II 1981-05-05
K811085 VENES II Jung Products, Inc. DWL Class II 1981-05-01
K810792 NEOCARE TEMPERATURE MONITOR Vickers America Medical Corp. FMZ Class II 1981-04-29
K810922 ARALUEN SKY GRAB BRIDLE Araluen, Inc. FPP Class I 1981-04-29
K803238 INTRAVASCULAR CATHETER G.D. Searle and Co. FOZ Class II 1981-04-23
K810721 PROCESS CHANGE Medlon, Inc. FPA Class II 1981-04-23
K810953 MODEL 533 PHOTOTHERAPY UNIT Narco Air-Shields LBI Class II 1981-04-23
K810574 SUCTION COLLECTION BOTTLE, DISPOSABLE Harvard Laboratories KDQ Class II 1981-04-21
K810049 PEDICAT* Pollak (Intl.), Ltd. KMJ Class I 1981-04-21
K810954 NORFOLK/NORWICH PRESSURE INFUSION BOX Medical Innovations Corp. KZD Class I 1981-04-21
K810855 INTERFACE 20 MICRON TRANSFUSION BLD. F. Abbott Laboratories CAK Class II 1981-04-21
K810310 K-Y LUBRICATING JELLY Johnson & Johnson Professionals, Inc. KMJ Class I 1981-04-21
K802918 ANTHRON CATHETER SET National Catheter Co. Div. Mallinckrodt FOZ Class II 1981-04-21
K810892 ELECTRO-SUCTION UNIT Jedmed Instrument Co. KDQ Class II 1981-04-17
K810846 SWEEN UNIVERSAL BED RAIL PADS Sween Corp. FNJ Class I 1981-04-17
K810311 STERI-VERS The Hilrad Co. LDS Class II 1981-04-17
K810896 VENTI-GARD JR. Con Med Equipment, Inc. KGX Class I 1981-04-17
K810242 UTENSIL & PROCEDURE TRAYS American Hospital Supply Corp. FRL Class I 1981-04-15
K810814 THERMOMETER, ELECTRONIC CLINICAL Her-Mar, Inc. FLL Class II 1981-04-10
K803302 PREHEPARINZED SYRINGE The University of Chicago FMF Class II 1981-04-08
K802170 SURU BLOOD COLLECTION SET Suru Chemicals & Pharmaceuticals, Ltd. FPA Class II 1981-04-06
K802169 SURU INFUSION SET TYPE J Suru Chemicals & Pharmaceuticals, Ltd. FPA Class II 1981-04-06
K810728 TAB PEDIATRIC CRIB Cambridge Scientific FMS Class II 1981-04-03
K810474 PROBE COVER Narco Air-Shields FLL Class II 1981-03-31
K810365 HAEMONETICS 170 Y INFUSION SET Haemonetics Corp. FPA Class II 1981-03-31
K810570 DRESSING CHANGE TRAY-MEDIUM Associated Medical Products Co. LDQ 1981-03-30
K810113 TERFUSION FINAL FILTER SET Terumo Medical Corp. FPB Class II 1981-03-27
K810653 VINYL ICE BAG First Industries, Inc. KYR Class I 1981-03-27
K810050 VECAFIX* Pollak (Intl.), Ltd. KGX Class I 1981-03-26
K810623 BAND-AID KITCHEN ASSORTMENT Johnson & Johnson Professionals, Inc. KGX Class I 1981-03-26
K810579 ADHESIVE I.V. CATHETER DRESSING Johnson & Johnson Professionals, Inc. KMK Class I 1981-03-26
K810295 COMPUTER INTERFACE MODULE Y FRN Class II 1981-03-20
K810646 OR/CS WRAP American Threshold Industries, Inc. FRG Class II 1981-03-20
K810609 PEDIATRIC POSITION HOLDER Kaye Products, Inc. FRP Class I 1981-03-20
K810580 SCOTCH BRAND ADHESIVE TAPE 3M Company KGX Class I 1981-03-20
K810252 STUMARK INFUSOR Stumark Corp. FRN Class II 1981-03-17
K810067 140 NEOCARE AIR CONTROLLED INCUBATOR Vickers America Medical Corp. FMZ Class II 1981-03-11
K810251 SYRINGE, ENT Megaplast, Inc. KYZ Class I 1981-03-11
K810379 EARETTE HEARING AID SEARS #8054 Oticon Corp. FSD Class I 1981-03-04
K810134 KEEP-ACCOUNT SHARPS DISPOSAL SYSTEM Info-Chem MMK Class II 1981-02-26
K810375 CENTURION STOPCOCK 3 WAY Tri-State Hospital Supply Corp. FMG Class II 1981-02-26
K810240 CLINIGUARD STERILE Clinipad Corp. KMF Class I 1981-02-19
K810209 IRRIJET Ackrad Laboratories KYZ Class I 1981-02-17
K810137 SOF-BAND HIGH STRETCH BANDAGES Johnson & Johnson Professionals, Inc. FQM Class I 1981-02-17
K810208 BLADE SAFE Instranetics, Inc. MMK Class II 1981-02-12
K810264 DISPOSABLE PILLOW Anago, Inc. KME Class I 1981-02-09
K810126 CURITY CURAD BANDAGES The Kendal Co. KGX Class I 1981-02-06
K810005 SAFEED EXTENSION TUBES Terumo Medical Corp. FPK Class II 1981-02-05
K803306 ALOFT STERILIZATION WRAP American Hospital Supply Corp. FRG Class II 1981-02-05
K803294 GUARDIAN STERILIZATION WRAP Kimberly-Clark Corp. FRG Class II 1981-02-02
K810173 TEMPERATURE FUNCTION BLOCK Honeywell, Inc. FLL Class II 1981-02-02
K802919 ISO-BAC INSTRUMENT WRAP American Convertors Div., American Pharmaseal FRG Class II 1981-02-02
K803153 ELASTIC ADHESIVE BANDAGES Abco Dealers, Inc. KGX Class I 1981-01-28
K803293 GUARDIAN PEEL POUCHES Kimberly-Clark Corp. FRG Class II 1981-01-28
K810053 JOHNSON & JOHNSON ADHESIVE FILM DRESSING Johnson & Johnson Professionals, Inc. KGX Class I 1981-01-28
K803078 SIMPLICITY INFUSION PUMP MODEL 2100A Critikon Company, LLC FRN Class II 1981-01-28
K802765 ACRODISC FILTER ASSEMBLY Gelman Sciences, Inc. FPB Class II 1981-01-21
K803200 IRRIGATION SET W/BULB SYRINGE Walpak Co. KYZ Class I 1981-01-21
K803204 IRRIGATION PISTON Walpak Co. FMF Class II 1981-01-21
K803206 SUCTION PROBE Bemis Health Care JOL Class II 1981-01-21
K802406 CYTOTRAN I BONE MARROW ASPIRATION SYSTEM Applied Medical Devices, Inc. FMF Class II 1981-01-15
K802829 SCANLAN VASCU-STATT Scanlan Intl., Inc. FMP Class I 1981-01-15
K803198 IRRIGATION SET W/PISTON SYRINGE Walpak Co. FMF Class II 1981-01-15
K803307 MATTRESS, AIR FLOATATION, ALTERN. PRESS. Intl. Medical Equipment Corp. FNM Class II 1981-01-13
K803187 ARGYLE UNIVERSAL POOLE SUCTION TUBE Sherwood Medical Co. JOL Class II 1981-01-09
K802778 LIQUID CRYSTAL THERM. 8 EVENT MONITOR Djinnii Industires, Inc. KPD Class II 1981-01-09
K803190 ETHOX/BARRON #2000 FOOD PUMP-ENTERAL FED Ethox Corp. FRN Class II 1981-01-09
K802966 I.V. ADDITIVE CAP Baxa Corp., Sub. of Cook Group, Inc. KPE Class II 1981-01-07

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