meddevicedb.com FDA Device Reference

Review Panel

General Hospital FDA 510(k) Clearances & Devices

Cleared Devices
15,723
Product Codes (page)
21
Latest Decision
1996-11-21

Clearances · page 83 of 158

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K963557 SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030 Tecnol Medical Products, Inc. FMQ Class I 1996-11-21
K963773 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT Tecnol Medical Products, Inc. FMQ Class I 1996-11-21
K963556 SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030) Tecnol Medical Products, Inc. FMQ Class I 1996-11-21
K963554 24448-010 SECURE-ALL FINGER CONTROL MITT Tecnol Medical Products, Inc. FMQ Class I 1996-11-21
K960512 GEMINI PC-ITX Imed Corp. FRN Class II 1996-11-21
K963462 COMFOR FOAM LIMB HOLDERS- SINGLE STRAP Bird & Cronin, Inc. FMQ Class I 1996-11-21
K963561 ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040) Tecnol Medical Products, Inc. FMQ Class I 1996-11-21
K963742 LATEX EXAMINATION GLOVES, POWDERED Arista Medi Prima LYY Class I 1996-11-20
K960315 FLAVORED LATEX PATIENT EXAMINATION P.T. Irama Dinamika Latex LYY Class I 1996-11-20
K963439 PEDIATRIC LIMB HOLDERS J. T. Posey Co. FMQ Class I 1996-11-19
K962096 MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES Medline Industries, Inc. LYY Class I 1996-11-19
K964286 ZOMED PASSIVE TEMPERATURE PROBE Zomed Intl. FLL Class II 1996-11-19
K963411 POSEY LAPTOP TRAYS J. T. Posey Co. FMQ Class I 1996-11-19
K963437 PELVIC HOLDERS J. T. Posey Co. FMQ Class I 1996-11-19
K955775 SAFECONNECT VALVE (CATALOG NO. XXXX) Faulding Medical Device Co. FPA Class II 1996-11-15
K963453 CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) Contour Fabricators, Inc. FMQ Class I 1996-11-15
K963471 SUPER SECURITY RESTRAINT Deroyal Industries, Inc. FMQ Class I 1996-11-14
K963478 SLEEVED/SLEEVELESS VEST RESTRAINT Deroyal Industries, Inc. FMQ Class I 1996-11-14
K963473 REUSABLE LIMB HOLDER Deroyal Industries, Inc. FMQ Class I 1996-11-14
K963491 STUCKEY STRAP-3 FINGER RESTRAINTS Stuckey Ent., Inc. FMQ Class I 1996-11-14
K963413 MULTIPLE LIMB HOLDERS J. T. Posey Co. FMQ Class I 1996-11-14
K963215 CLAMPLESS VALVED CATHETER - MIDLINE (CVC-ML) Bmw Medical, Inc. LJS Class II 1996-11-14
K963470 CRISS-CROSS VEST RESTRAINT Deroyal Industries, Inc. FMQ Class I 1996-11-14
K963472 PEDIATRIC VEST RESTRAINT Deroyal Industries, Inc. FMQ Class I 1996-11-14
K963409 POSEY HUGGER J. T. Posey Co. FMQ Class I 1996-11-14
K963469 MITTENS Deroyal Industries, Inc. FMQ Class I 1996-11-14
K963210 VAIL 100 PEDIATRIC CRIB Vail Products, Inc. FMS Class II 1996-11-13
K963464 RESTRAINT NET Deroyal Industries, Inc. FMQ Class I 1996-11-12
K963490 PROTECTIVE RESTRAINT - BELTS Smith and Nephew Donjoy, Inc. FMQ Class I 1996-11-12
K963489 WHEEL CHAIR ACCESSORY Smith and Nephew Donjoy, Inc. FMQ Class I 1996-11-12
K963492 PROTECTIVE RESTRAINT Smith and Nephew Donjoy, Inc. FMQ Class I 1996-11-12
K963656 FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING Adri KMF Class I 1996-11-12
K963049 STERI-AID KIT Steri-Aid, Inc. FQZ Class I 1996-11-12
K963477 PEDIATRIC MITTENS Deroyal Industries, Inc. FMQ Class I 1996-11-12
K963387 DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP Morrison Medical Products FMQ Class I 1996-11-08
K963370 CINCH STRAP WITH BUCKLE Morrison Medical Products FMQ Class I 1996-11-08
K963112 MMG MULTI LUMON EXTENSION SET Mmg Healthcare, Inc. FPA Class II 1996-11-08
K963374 TORSO/WAIST RESTRAINT Morrison Medical Products FMQ Class I 1996-11-08
K963371 BEST STRAP RESTRAINT Morrison Medical Products FMQ Class I 1996-11-07
K963372 HEELBO ER WRIST RESTRAINT Heelbo, Inc. FMQ Class I 1996-11-07
K963431 POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER Zimmer, Inc. FMQ Class I 1996-11-06
K963399 MORRISON MEDICAL STRETCHER/COT AND BACKBOARD RESTRAINTS Morrison Medical Products FMQ Class I 1996-11-06
K963435 ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE Zimmer Patient Care Division FMQ Class I 1996-11-06
K963867 NEO-CARE CATHETERIZATION TRAY Klein-Baker Medical, Inc. FOZ Class II 1996-11-06
K963416 ANKLE RESTRAINT SYSTEM Morrison Medical Products FMQ Class I 1996-11-06
K963494 MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP Morrison Medical Products FMQ Class I 1996-11-06
K963138 SPIDER STRAP Bdm Medical, Inc. FMQ Class I 1996-11-06
K964051 NEEDLE, ACUPUNCTURE S-Tcm Enterprises, Inc. MQX Class II 1996-11-05
K963060 HEELBO SECURITY BELT Heelbo, Inc. FMQ Class I 1996-11-04
K963199 HEELBO PELVIC RESTRAINT Hollister, Inc. FMQ Class I 1996-11-01
K963099 HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET Heelbo, Inc. FMQ Class I 1996-11-01
K963419 MORRISON MEDICAL WRIST RESTRAINT Morrison Medical Products FMQ Class I 1996-10-31
K960590 TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE Aladan Corp. LYY Class I 1996-10-31
K963527 UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS Alimed, Inc. FMQ Class I 1996-10-31
K963041 HEELBO LIFE JACKET WITH CROTCH SUPPORT Heelbo, Inc. FMQ Class I 1996-10-31
K963393 MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT Depuy, Inc. FMQ Class I 1996-10-31
K963602 BIODERM PVP FOAM WOUND DRESSING Bioderm, Inc. KMF Class I 1996-10-30
K963504 MEDLINE OPEN END FINGER CONTROL MITT Medline FMQ Class I 1996-10-29
K963751 PT SYNTHETIC MEDICAL GLOVES, POWDER FREE Shanghai PT Plastics Enterprise Company, Ltd. LYZ Class I 1996-10-29
K963797 PM SYNTHETIC MEDICAL GLOVES, POWDER FREE Shanghai PM Plastics Enterise Co., Ltd. LYZ Class I 1996-10-29
K963378 MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER Medline Industries, Inc. FMQ Class I 1996-10-29
K960431 PRESSURE STOPCOCK/MANIFOLD Scientific Device Manufacturer, LLC FPA Class II 1996-10-29
K963528 ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) Alimed, Inc. FMQ Class I 1996-10-29
K963526 STRAP WEDGE Alimed, Inc. FMQ Class I 1996-10-28
K954448 VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM Schiff & Co. FRA Class II 1996-10-28
K961677 ACUPUNCTURE NEEDLES K.S. Choi Corp. MQX Class II 1996-10-28
K962938 EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE) Excelsior Medical Corp. FOZ Class II 1996-10-25
K963096 ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING Smith & Nephew United, Inc. KMF Class I 1996-10-25
K963684 A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED) Arrow Intl., Inc. LJT Class II 1996-10-24
K962963 CHECKMATE ANKLE RESTRAINT SYSTEM Hollister, Inc. FMQ Class I 1996-10-24
K963710 PACER PLUS SYNTHETIC MEDICAL VINYL PATIENT EXAMINATION GLOVE POWDER FREE Canopus Medical Supply Co., Ltd. LYZ Class I 1996-10-24
K962964 HEELBO JOHNNY GRAIT BELT SECURITY BELT Hollister, Inc. FMQ Class I 1996-10-24
K963560 MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE Pwa Industries Sdn. Bhd. LYY Class I 1996-10-24
K963514 PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVES (POWDERED) Shanghai PM Plastics Enterise Co., Ltd. LYZ Class I 1996-10-24
K950686 I.V. START KIT James J. Schramm FMI Class II 1996-10-24
K962920 RENTON SUCTION DEVICE U.S. PATENT*4,767,404 R&S Surgical, LLC GCX Class II 1996-10-21
K962250 CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED Carroll Healthcare, Inc. FNL Class II 1996-10-21
K963452 MEDLINE ZIPPER SLEEVED VEST Medline FMQ Class I 1996-10-18
K962893 INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE Baxter Healthcare Corp FPA Class II 1996-10-18
K963570 SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) Smiths Industries Medical Systems, Inc. FMJ Class II 1996-10-18
K963569 WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH Medline Industries, Inc. FMQ Class I 1996-10-18
K962831 THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE Heelbo, Inc. FMQ Class I 1996-10-18
K952001 GEON ELECTRONIC THERMOMETER Geon Corp. FLL Class II 1996-10-18
K963360 MEDLINE BODY HOLDER Medline Industries, Inc. FMQ Class I 1996-10-18
K963362 MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT Medline Industries, Inc. FMQ Class I 1996-10-18
K963458 PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS Skil-Care Corp. FMQ Class I 1996-10-18
K963404 MEDLINE PELVIC HOLDER Medline Industries, Inc. FMQ Class I 1996-10-18
K962839 HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP Heelbo, Inc. FMQ Class I 1996-10-18
K963353 LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46) Reckitt Benckiser, Inc. LRJ Class I 1996-10-18
K963009 DELTEC SUBCUTANEOUS INFUSION SET Sims Deltec, Inc. FPA Class II 1996-10-18
K962832 HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP Heelbo, Inc. FMQ Class I 1996-10-18
K962834 HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP Heelbo, Inc. FMQ Class I 1996-10-18
K963097 CLAMPLESS VALVED CATHETER-PICC (CVC-PICC) Bmw Medical, Inc. LJS Class II 1996-10-18
K963463 STRAIT JACKET Deroyal Industries, Inc. FMQ Class I 1996-10-16
K963769 SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES Seirin-America, Inc. MQX Class II 1996-10-16
K963573 ELVAREX Jobst A Beiersdorf Co. DWL Class II 1996-10-16
K963012 BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM) Bioject, Inc. LHI Class II 1996-10-15
K954416 POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES Hartalega Sdn Bhd LYY Class I 1996-10-11
K963294 HEELBO WRAP AROUND VEST Heelbo, Inc. FMQ Class I 1996-10-11
K962149 SAFETY CRADLE Specialized Health Products, Inc. FMI Class II 1996-10-11

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