meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
31
Latest Decision
1989-03-29

Clearances · page 125 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K891369 COMPLE-SAFE VINYL EXAMINATION GLOVES Universal Gloves Corp. LYZ Class I 1989-03-29
K891366 BIOSIGN BIOLOGICAL INDICATOR (EIGHT MONTH EXP.) Mdt Corp., Inc. FRC Class II 1989-03-29
K890012 HUNTLEIGH DYNAMIC FLOTATION SYSTEM Huntleigh Technology, Inc. FNM Class II 1989-03-29
K891291 PATIENT EXAMINATION GLOVES (LATEX) Cp Products, Inc. LYY Class I 1989-03-29
K890985 VINYL PATIENT EXAMINATION GLOVE Am Gloves Co., Ltd. LYZ Class I 1989-03-29
K885140 MULTI-PURPOSE CONTROL SYSTEM Colliers Sterilizer Sales & Service Co., Inc. FLE Class II 1989-03-29
K890435 VITAACCESS CATHETER INTRODUCER KIT Vitaphore Corp. FOZ Class II 1989-03-29
K891425 PATIENT EXAMINATION GLOVES (LATEX) Encore Technology, Inc. LYY Class I 1989-03-29
K891298 AMBIDERM(TM) PATIENT EXAMINATION GLOVE (LATEX) Medi Tex, Inc. LYY Class I 1989-03-29
K885205 AQUADERM Laivan Corp. KGX Class I 1989-03-29
K891511 PATIENT EXAMINATION GLOVES (LATEX) Oon Corp. Resources LYY Class I 1989-03-29
K890816 PATIENT EXAMINATION GLOVES Dan Co., Ltd. LYY Class I 1989-03-29
K890880 ALADAN STERILE LATEX MEDICAL GLOVE Aladan Corp. LYY Class I 1989-03-29
K891378 PATIENT EXAMINATION GLOVES (LATEX) Sri Johani Sdn. Bhd. LYY Class I 1989-03-29
K884612 FRANKLIN COLLECTOR(R) Franklin Diagnostics, Inc. FQZ Class I 1989-03-27
K891434 PATIENT EXAMINATION GLOVES (LATEX) Sime Darby USA LYY Class I 1989-03-24
K891424 PATIENT EXAMINATION GLOVES (LATEX) Oon Corp. Resources LYY Class I 1989-03-24
K891120 TEXMED LATEX EXAMINATION GLOVE Transcorp LYY Class I 1989-03-24
K890462 LATEX EXAMINATION GLOVE C.R. Trading, Inc. LYY Class I 1989-03-24
K890847 LATEX EXAMINATION GLOVES Prime Merit Intl. Corp. LYY Class I 1989-03-23
K891447 PATIENT EXAMINATION GLOVES (LATEX) Lily Corp. LYY Class I 1989-03-23
K890857 PATIENT EXAMINATION GLOVES (STERILE & NON-STERILE) Health & Hospital Intl. LYY Class I 1989-03-23
K891206 LATEX EXAMINATION GLOVES Charug Fang Ent. LYY Class I 1989-03-23
K891170 PATIENT EXAMINATION GLOVE (LATEX) Ching Pax Trading Co., Ltd. LYY Class I 1989-03-23
K891446 PATIENT EXAMINATION GLOVES (LATEX) Felda Rubber Corp. LYY Class I 1989-03-23
K890456 PTI - LATEX EXAMINATION GLOVES Precision Trading Intl., Inc. LYY Class I 1989-03-23
K891443 PATIENT EXAMINATION GLOVES (LATEX) Sukas Sdn Bhd LYY Class I 1989-03-23
K890627 UNSTERILE PATIENT EXAMINATION GLOVE Aladan Corp. LYY Class I 1989-03-23
K890062 CADD-PCA MODEL 5800 AMBULATORY INFUSION PUMP Pharmacia Deltec, Inc. FRN Class II 1989-03-23
K891181 PATIENT EXAMINATION GLOVES (LATEX) Behn Meyer & Co. (M) Sdn Bhd LYY Class I 1989-03-23
K891067 PATIENT EXAMINATION GLOVE, VINYL Sun Flower Gloves Co., Ltd. LYZ Class I 1989-03-23
K891205 LATEX EXAMINATION GLOVES Ming Hsien Rubber Industrial Co. LYY Class I 1989-03-22
K891207 LATEX EXAMINATION GLOVES Chung Yuan Rubber & Plastics Co. LYY Class I 1989-03-22
K890149 SURGIMAX (LATEX EXAM GLOVES) National Dental Supply, Inc. LYY Class I 1989-03-22
K891153 PATIENT EXAMINATION GLOVES (LATEX) K.B. Latex Products Sdn. Bhd. LYY Class I 1989-03-22
K891209 PATIENT EXAMINATION GLOVES (LATEX) Chung Yuan Trading Co., Ltd. LYY Class I 1989-03-22
K891257 DEFEND LATEX EXAMINATION GLOVES Carl Parker Associates, Inc. LYY Class I 1989-03-22
K891245 PATIENT EXAMINATION GLOVES (LATEX) Terang Nusa Sdn Bhd LYY Class I 1989-03-22
K891232 PATIENT EXAMINATION GLOVES Supergrade Healthcare Products Sdn. Bhd. LYY Class I 1989-03-22
K891271 PATIENT EXAMINATION GLOVE (LATEX) Dr. Boo Co., Ltd. LYY Class I 1989-03-22
K884657 LILY I.V. SET Modec Co., Inc. FPA Class II 1989-03-22
K891220 SINTON LATEX EXAMINATION GLOVE Sinton Latex Chemical Industries Co., Ltd. LYY Class I 1989-03-22
K891132 PATIENT EXAMINATION GLOVE Phoenix Medical Technology, Inc. LYZ Class I 1989-03-22
K891204 LATEX EXAMINATION GLOVES Advance Rubber, Inc. LYY Class I 1989-03-21
K891242 PATIENT EXAMINATION GLOVES (LATEX) Dr. Boo Co., Ltd. LYY Class I 1989-03-21
K891208 PATIENT EXAMINATION GLOVES (LATEX) Cho FU Industrial Co., Ltd. LYY Class I 1989-03-21
K885208 RECEPTAL SAF-GARD(TM) SYSTEM Abbott Laboratories GCX Class II 1989-03-17
K891003 LATEX EXAMINATION GLOVES Ruhn Chang Industrial Co., Ltd. LYY Class I 1989-03-17
K885308 ELECTRONIC DIGITAL THERMOMETER Ewig Industries Co. , Ltd. FLL Class II 1989-03-16
K891157 DEFEND LATEX EXAMINATION GLOVES Carl Parker Associates, Inc. LYY Class I 1989-03-16
K884660 BIOSONIC ULTRASONIC CLEANING SYSTEM Whaledent Intl. Div. Ipco FLG Class I 1989-03-16
K891065 LATEX EXAMINATION GLOVES Modern Rubber Industrial Co., Ltd. LYY Class I 1989-03-16
K885122 NEEDLE STICK Poncy, Inc. FMI Class II 1989-03-14
K891103 STERILE PATIENT EXAMINATION GLOVE Boston Medical Corp. LYY Class I 1989-03-14
K885270 PERSONAL TRANSFER SYSTEM Columbus Mckinnon Corp. FNG Class II 1989-03-14
K890272 BAG DECANTER Superior Medical Products KPE Class II 1989-03-14
K890538 GUARDS LATEX & SAFE-CONTACT EXAMINATION GLOVES Boston Medical Corp. LYY Class I 1989-03-10
K890457 MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP Medtronic Minimed FRN Class II 1989-03-08
K884133 PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP Preemicare Corp. LBI Class II 1989-03-08
K885187 MODEL 1000 ELECTRONIC CLINICAL THERMOMETER Mon-A-Therm, Inc. FLL Class II 1989-03-08
K885334 VAC-RITE Bd Becton Dickinson Vacutainer Systems Preanalytic GCX Class II 1989-03-08
K884103 REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES Boehringer Laboratories GCX Class II 1989-03-03
K884141 MONOPLACE HYPERBARIC EXTENSION SET (L 11055) Abbott Laboratories FPA Class II 1989-02-28
K890620 STICK-GARD SAFETY NEEDLE Ziehm International, Inc. FMI Class II 1989-02-28
K882249 M.I.P. - PUMP Intro-Med, Inc. FRN Class II 1989-02-28
K883796 LIFECARE MICRO PUMP Abbott Laboratories FRN Class II 1989-02-28
K890685 BARD UMBILICAL VESSEL CATHETER C.R. Bard, Inc. FOS Class II 1989-02-28
K881759 BT-1 INFUSION PUMP Ferring Laboratories, Inc. FRN Class II 1989-02-28
K883873 INFUSION FLUID WARMER Pmt Corp. LGZ Class II 1989-02-28
K883073 N.M.D.C. USER PROTECTIVE HYPODERMIC SYRINGE SYSTEM National Medical Device Corp. FMF Class II 1989-02-28
K890314 PROTECTOR (SURGICAL INSTRUMENT) Richard-Allan Medical Ind., Inc. MMK Class II 1989-02-27
K885083 INFUSA-PLATE(TM) EX Kalayjian Ent. FRN Class II 1989-02-27
K885241 BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT King Mfg. Co. FNJ Class I 1989-02-24
K890155 MDP DISPOSABLE SYRINGE Mediplas Marketing FMF Class II 1989-02-24
K883986 CRIS ADAPTER Y FPA Class II 1989-02-24
K884765 CLINICAL ELECTRONIC THERMOMETERS Sheridan Catheter Corp. FLL Class II 1989-02-16
K884921 HEMO-SANITAS SYRINGE Hemo-Sanitas, Inc. C/O Greenberg Irwin & Weisinger FMF Class II 1989-02-09
K884806 LUMED EXPANDO-CATH, ACTIV Luther Medical Products, Inc. FOZ Class II 1989-02-08
K883660 DERMASTRIP Bd Becton Dickinson Vacutainer Systems Preanalytic KGX Class I 1989-02-08
K890127 INTRAVASCULAR ADMINISTRATION SET Multi-Med, Inc. FMI Class II 1989-02-03
K884701 CATH-FINDER SYSTEM Pharmacia Deltec, Inc. FOZ Class II 1989-02-01
K882544 CUDDLE UP PILLOW Ohio Medical Instrument Co., Inc. FRP Class I 1989-01-31
K883805 ROCKET SEX CRIME KIT A & A Medical, Inc. FMC Class I 1989-01-31
K885264 WINGED INFUSION SET E-Z-Em, Inc. FPA Class II 1989-01-31
K884102 MODIFIED 7 INCH CONTINUOUS INFUSION SETS Quinton, Inc. FPA Class II 1989-01-31
K890082 DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN Bd Becton Dickinson Vacutainer Systems Preanalytic FMF Class II 1989-01-31
K884792 VASCULAR ACCESS PORT HUBER POINT INFUSION NEEDLES Infucare Products, Inc. FMI Class II 1989-01-30
K883718 MERIT HI-FLEX(TM) Merit Medical Systems, Inc. FPK Class II 1989-01-30
K884233 QUADROJECT(TM) Ellis Pharmaceutical Consulting, Inc. FMF Class II 1989-01-30
K873200 KARLSON OZONE STERILIZER MODEL 100B Life Enhancement Technologies, LLC FLF Class II 1989-01-27
K882975 RE-VENT ARTERIAL BLOOD SAMPLER AND/OR BIOSAMPLER Richmann Laboratories FMF Class II 1989-01-25
K885019 BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI. Bemis Health Care FRG Class II 1989-01-25
K885030 STANDARD ADMINISTRATION SETS 3M Company FPA Class II 1989-01-24
K884615 ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK Pymah Corp., Ati Div. FRC Class II 1989-01-19
K883905 ARROW PNEUMOTHORAX KIT, AK-01500 Arrow Intl., Inc. JOL Class II 1989-01-19
K884472 AIR-ELECTRONIC AIR CLEANER (FILTER) White-Rodgers, Div. Emerson Electric Co. FRF Class II 1989-01-19
K885346 NON-STERILE VINYL GLOVES Daw Shin Industrial Co., Ltd. FMC Class I 1989-01-18
K883214 THORACIC SUPPORT SYSTEM Storer Medical Products KMO Class I 1989-01-17
K884767 ATI-PYMAH DISPOSABLE BIOLOGICAL TEST PACK Pymah Corp., Ati Div. FRC Class II 1989-01-10
K884463 CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS Ohmeda Medical FMG Class II 1989-01-09

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