meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
35
Latest Decision
1996-01-30

Clearances · page 87 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K954823 VENIPUNCTURE KIT Winfield Industries FPA Class II 1996-01-30
K952837 DARWIN HYPODERMIC SAFETY SYSTEM (DHSS) Emk Enterprises, LLC FMI Class II 1996-01-30
K954729 PEN-INJECT 2.25 Scandinavian Health , Ltd. KZH Class II 1996-01-29
K950518 MIELE G 7781 DENTAL THERMAL DISINFECTOR Miele Professional LDS Class II 1996-01-26
K953529 STRATO/INFUSAID LIFE & INFUSE-A-PORT IMPLANTABLE PORT SYSTEM Strato/Infusaid, Inc. LJT Class II 1996-01-26
K953746 ARROW HIGH FLOW FLUID ADMINSITRATION SET W/BLOOD FILTER & EXTENSION SET Arrow Intl., Inc. FPA Class II 1996-01-26
K954153 ARISTA VINYL EXAMINATION GLOVES Arista Latindo Industrial Ltd. P.T LYZ Class I 1996-01-26
K955658 LACERATION TRAY Transidyne General Corp. FRG Class II 1996-01-25
K955151 MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR Bio-Medical Devices, Inc. BYY Class II 1996-01-24
K955149 MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL Bio-Medical Devices, Inc. BYY Class II 1996-01-24
K953500 HEMO-BARRIER Asia Dynamics, Inc. KMF Class I 1996-01-24
K954887 STERILE WATER O.9% STERILE SALINE Lockett Medical Corp. FOZ Class II 1996-01-24
K953068 OXBORO-MEDICAL FOAM INSTRUMENT HOLDER Oxboro Medical Intl., Inc. KCT Class II 1996-01-23
K923693 KLORMAN Matrix Medica, Inc. LRJ Class I 1996-01-23
K955029 POWDER-FREE LATES EXAM GLOVES WITH PROTEIN CLAIM Shen Wei (Usa), Inc. LYY Class I 1996-01-23
K954984 MINIBORE STOPCOCK SET Distronic Sterile Products, Inc. FMG Class II 1996-01-23
K955055 NULIFE Med-Tech Rubber & Engineering Industries LYY Class I 1996-01-23
K955150 MAXI-FLOW Bio-Medical Devices, Inc. BYY Class II 1996-01-23
K953335 MICRO THERAPEUTICS VARIABLE INFUSION LENGTH CATHETER Micro Therapeutics, Inc. FOZ Class II 1996-01-23
K954983 EXTENSION SET WITH CHECK VALVE Distronic Sterile Products, Inc. FPA Class II 1996-01-23
K940832 I.V. ADMINISTRATION SET CONNECTING DEVICE Sierra Medical Devices FPA Class II 1996-01-23
K954869 MEDCARE YANKAUER SUCTION DEVICE Medcare Custom Packaging, Inc. GCX Class II 1996-01-19
K952799 ABBOTT XL3M INFUSION PUMP Abbott Laboratories FRN Class II 1996-01-18
K954500 HOSPITEC MEDI-BUTLER Hospitec, Inc. FMI Class II 1996-01-18
K943314 ADHESIVE BANDAGES WITH OTC DRUG Johnson & Johnson Consumer Products, Inc. KGX Class I 1996-01-17
K954766 PRESSURE GUARD ALTERNATING PRESSURE MATTRESS Span-America Medical Systems, Inc. FNM Class II 1996-01-11
K955053 NIPRO SCALP VEIN SET (DISPOSABL PSV SET) Nissho Corp. FOZ Class II 1996-01-04
K953462 PATIENT EXAMINATION GLOVES P.T. Irama Dinamika Latex LYY Class I 1996-01-04
K954720 STRATO/INFUSAIF INFUSE-A-CATH CENTRAL VENOUS CATHETERS Strato/Infusaid, Inc. LJS Class II 1996-01-04
K952541 PACIFIER THERMOMETER Regitar U.S.A., Inc. FLL Class II 1996-01-02
K955142 DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A Salutron, Inc. FLL Class II 1995-12-29
K946219 POP-N-LOK SYRINGE Retractable Technologies, Inc. MEG Class II 1995-12-28
K952787 FOAM INSTRUMENT GUARD Oxboro Medical Intl., Inc. KCT Class II 1995-12-28
K954855 POWDER FREE PLUS PATIENT EXAMINATION GLOVE Tillotson Healthcare Corp. LYY Class I 1995-12-28
K954275 MEPORE PLUS (9X15CM) Scott Health Care KMF Class I 1995-12-27
K950621 BIOFILL BIOCELLULOSE DRESSING STERILE The Purdue Frederick Co. KMF Class I 1995-12-26
K954918 COMBIDERM ACD Convatec, A Bristol-Myers Squibb Co. KMF Class I 1995-12-26
K951429 FLEXIFLO 6.1 ENTERAL NUTRITION PUMP Ross Products LZH Class II 1995-12-22
K953098 VOLUMETRIC INFUSION PUMP Baxter Healthcare Corp FRN Class II 1995-12-22
K954442 STERILE ISOTONIC SALINE & STERILE WATER Medcare Custom Packaging, Inc. JOL Class II 1995-12-21
K952606 TARGETT PATCH Cutting Edge Technologies, Inc. KGX Class I 1995-12-21
K954574 PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES Tillotson Healthcare Corp. LZA Class I 1995-12-21
K954573 PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES Tillotson Healthcare Corp. LZA Class I 1995-12-21
K954434 OLYMPIC INFANT THERMOMETER Olympic Medical Corp. FLL Class II 1995-12-20
K954274 MEPORE (6X7) Scott Health Care KMF Class I 1995-12-19
K950970 INFUSION SET Surgiplast , Ltd. FPA Class II 1995-12-18
K954409 PS MEDICAL IPI VASCULAR ACCESS CATHETER Pudenz-Schulte Medical Research Corp. LJS Class II 1995-12-18
K952073 PACI-TEMP, PACIFIER WITH DIGITAL THERMOMETER Intelligent Product Limited Co. FLL Class II 1995-12-18
K954870 SIMS DELTEC ANTI-SIPHON VALVE Sims Deltec, Inc. FPA Class II 1995-12-15
K952051 SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES) Wembley Rubber Products (M) Sdn Bhd LZA Class I 1995-12-15
K955030 SQUARE ONE SAFETY SYRINGE Square One Medical, LP MEG Class II 1995-12-15
K951938 SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES Wembley Rubber Products (M) Sdn Bhd LZA Class I 1995-12-15
K955091 DISPOSABLE POWDER FREE VINYL SYNTHETIC GLOVES Safehealth Medical Supply Corp. LYZ Class I 1995-12-15
K952154 SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES Wembley Rubber Products (M) Sdn Bhd LZA Class I 1995-12-15
K953465 KENTEMP Kentron Health Care, Inc. FLK Class II 1995-12-15
K954422 PER-Q-CATH MID-LINE Gesco Intl., Inc. LJS Class II 1995-12-15
K950201 ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER Sherwood Medical Co. JOL Class II 1995-12-15
K955177 OLYMPIC SMART SCALE Olympic Medical Corp. FRW Class I 1995-12-14
K954846 OLYMPIC SMART SCALE Olympic Medical Corp. FRW Class I 1995-12-14
K955138 ANTI-EM/GP STOCKINGS Jobst Institute, Inc. DWL Class II 1995-12-13
K954300 ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY Sherwood Medical Co. FOS Class II 1995-12-13
K952645 VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE Vital Signs, Inc. FOZ Class II 1995-12-13
K953731 PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION) Abbott Laboratories FRN Class II 1995-12-13
K953120 VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE Vital Signs, Inc. FOZ Class II 1995-12-13
K954533 ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVES Eci Medical Technologies, Inc. LZA Class I 1995-12-11
K954381 SHANGHAI POSEDON PLASTIC PRODUCTS VINYL EXAM GLOVES Shanghai Poseidon Plastic Products Co., Ltd. LYZ Class I 1995-12-11
K954841 MODEL D-285N ADMINISTRATION SET Patient Solutions, Inc. FPA Class II 1995-12-11
K952155 SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES Wembley Rubber Products (M) Sdn Bhd LZA Class I 1995-12-11
K954365 POWDER FREE LATEX EXAMINATION GLOVES Perusahaan Getah Asas Sdn. Bhd. LYY Class I 1995-12-11
K954216 OLYMPIC WARM-BASSINET Olympic Medical Corp. FOH Class I 1995-12-08
K934014 VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT Biotrol, USA, Inc. LRJ Class I 1995-12-06
K934150 BIOCIDE CLEANER/DISINFECTANT Juan Sierra LRJ Class I 1995-12-06
K950245 UNIQUE NEEDLE Unique Management Ent., Inc. FMF Class II 1995-12-06
K954185 RE-BAG MULTI-USE POUCH, LARGE & SMALL Miltex, Inc. KCT Class II 1995-12-04
K954297 CELSITE VENOUS ACCESS SYSTEM OTW B.Braun Medical, Inc. LJT Class II 1995-12-01
K954611 DRAGER PT4000 PHOTOTHERAPY SYSTEM Drager, Inc. LBI Class II 1995-12-01
K953626 SYRINGE MAGNIFIER Innovative Premiums, Inc. FMF Class II 1995-12-01
K954726 STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) Stryker Endoscopy GCX Class II 1995-11-29
K954813 ICU EXTENSION KIT Icu Medical, Inc. FPA Class II 1995-11-29
K953254 STRATO/INFUSAID INFUSE-A-KIT Strato/Infusaid, Inc. LJT Class II 1995-11-29
K954181 CANYONS BI-DIRECTIONAL CHECK VALVE Canyon Medical Products KYX Class I 1995-11-29
K950969 DISPOSABLE SYRINGE Surgiplast , Ltd. FMF Class II 1995-11-29
K953797 SHARPS DISPOSAL CONTAINERS Bemis Mfg. Co. MMK Class II 1995-11-27
K954090 AUTO SUTURE* STERILIZATION TRAY** United States Surgical, A Division of Tyco Healthc KCT Class II 1995-11-22
K952447 HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER Hill-Rom, Inc. FPO Class II 1995-11-22
K954007 PARALLEL Johnson & Johnson Consumer Products, Inc. KGX Class I 1995-11-22
K954104 PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES C.R. Bard, Inc. LJS Class II 1995-11-21
K954064 BECTON DICKINSON SYRINGSE Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1995-11-21
K954123 LOW PROFILE SAFSITE Y-SITE B.Braun Medical, Inc. FPA Class II 1995-11-21
K940645 KEY-LOK(TM) SYSTEM St. Paul Medical FMI Class II 1995-11-20
K945548 MEDIVAX Vitajet Corp. KZE Class II 1995-11-20
K944351 SMARTDOSE IV PREFILLED INFUSION CONTAINER River Medical, Inc. FRN Class II 1995-11-15
K954433 VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEM Gish Biomedical, Inc. LJT Class II 1995-11-15
K935767 SIMS SILO NEEDLE DE-ACCESS ENCLOSURE Sims Deltec, Inc. LJT Class II 1995-11-15
K954051 SIME POWDERFREE PLUS Sime Health, Ltd. LYY Class I 1995-11-15
K954880 LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION) Siam Sempermed Corp., Ltd. LYY Class I 1995-11-15
K952219 SUCTION TIP CLEANER CUP Moore/Gobel GCX Class II 1995-11-15
K944352 SMARTDOSE III INFUSION CONTAINER River Medical, Inc. FRN Class II 1995-11-15
K942855 NON-CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES Evergrade Healthcare Products Sdn Bhd LYY Class I 1995-11-15
K954919 MEROCEL SOFT WOUND DRESSING Merocel Corp. KMF Class I 1995-11-14

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