FDA 510(k) clearances — page 977
clearances on record, most recent first.
Clearances — page 977
97,601–97,700 of 176,637- K963627 — (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
- K963664 — DENTAL HANDPIECE AND ACCESSORY
- K963684 — A2 PORT, DUAL LUMEN SYSTEM WITH DETACHED CATHETER, CATALOG # AP-01518 (MODIFIED)
- K963710 — PACER PLUS SYNTHETIC MEDICAL VINYL PATIENT EXAMINATION GLOVE POWDER FREE
- K963734 — ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS
- K960056 — USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC
- K961247 — AS/3 LIGHT MONITOR
- K961844 — OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]
- K961888 — PILLAR 4-WHEEL SCOOTER
- K962034 — SC, CEMENTLESS HIP SYSTEM
- K962268 — CHROME COBALT BALL HEAD
- K962713 — DPAP STEALTH SLEEPNET MODEL NUMBER 84000
- K962846 — EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM
- K962869 — GSP1 - GAS SELECTION PANEL
- K962871 — ODS1 - HOOD DRIVER
- K962907 — SKINNY,FRANSEEN,WESCOTT NEEDLES
- K962944 — TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
- K962945 — CORDIS OPTA PTA BALLOON CATHETER
- K962990 — RADIONICS SIPHON LIMITING DEVICE (SLD)
- K963213 — BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
- K963222 — MICROGYN PLUS STIMULATION DEVICE
- K963227 — WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175
- K963301 — STANDARD WHEELCHAIR
- K963772 — SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225)
- K954651 — ELECTRODE RECORDING CATHETER
- K955470 — ACTION POTENTIAL SIMULATION THERAPY DEVICE
- K962426 — CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
- K962645 — ISOLA TWISTER CONNECTOR
- K962879 — SALTERLABS 8660 SERIES NEBULIZER
- K962881 — KSEA CULDOCENTESIS SET
- K963333 — OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)
- K952083 — TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE
- K954492 — MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
- K955299 — DPS 4 DIALYZER PREPARATION SYSTEM
- K960810 — BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X 35MM,2MM X 35MM
- K961126 — PULSE DOSE SERIES
- K962250 — CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED
- K962611 — BARD EAGLE INFLATION DEVICE
- K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404
- K962931 — SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
- K963031 — GENXCATHETER
- K963234 — STAPLE REMOVAL KIT
- K963338 — UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH
- K951014 — ISOLAB'S T4 TEST KIT
- K952001 — GEON ELECTRONIC THERMOMETER
- K954994 — TRUST
- K960491 — MICRO HAEMATOCRIT CENTRIFUGE
- K960972 — DISPOSABLE GAS SAMPLING INTERFACE KITS
- K961439 — ABBOTT CELL-DYN 4000 SYSTEM
- K961624 — FLEXART TMJ COIL
- K961838 — RESPIRGARD II, SPIROGARD
- K961904 — AQ HYDROPHILIC DILATORS
- K962014 — 3I SINGLE USE, DISPOSABLE DRILLS,TAPS,BURS, ETC.
- K962176 — TPP
- K962409 — OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT
- K962582 — OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT
- K962610 — DUAL INTEGRATOR DENTAL IMPLANT ACCESSORIES
- K962831 — THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE
- K962832 — HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP
- K962834 — HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP
- K962839 — HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP
- K962844 — REPLACE TPS COATED IMPLANTS
- K962845 — REPLACE HA COATED IMPLANTS
- K962877 — MIDWEST 300 SE
- K962893 — INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE
- K962919 — VITROS IMMUNODIAGNOSTIC SYSTEM
- K963009 — DELTEC SUBCUTANEOUS INFUSION SET
- K963097 — CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)
- K963345 — ADVANTAGE WINDOWS TISSUE VOLUME OPTION
- K963353 — LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46)
- K963360 — MEDLINE BODY HOLDER
- K963362 — MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT
- K963404 — MEDLINE PELVIC HOLDER
- K963408 — VISUALINE D HCG
- K963452 — MEDLINE ZIPPER SLEEVED VEST
- K963458 — PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS
- K963569 — WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH
- K963570 — SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)
- K963630 — C.O.L.D.A.
- K963856 — RAND NASAL PACKING
- K950197 — MICROCO
- K952790 — LOG-A-RYTHM MODEL 100 AND MODEL 1001
- K955064 — SPETZLER TI 100 ANEURYSM CLIP
- K960434 — INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
- K960479 — ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
- K961499 — LAGUNA SOFTIP DIAGNOSTIC CATHETERS
- K962822 — OPTICHAMBER
- K962830 — VISTA BRITE TIP CATHETERS
- K963206 — S-ROM HIP SYSTEM - LOCKING PLUG
- K963443 — PROD. NO. 02-031 - LACERATION TRAY
- K960074 — CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR
- K960567 — HF MEGA EAR
- K962848 — HANS RUDOLPH NASAL CPAP MASK
- K963463 — STRAIT JACKET
- K963573 — ELVAREX
- K963769 — SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES
- K963908 — HEMOCUE HEMOLIN
- K940643 — OSMED EPI-GUIDE
- K961290 — IUP - TIP TRANS, IUP - PROXI TRANS
- K961688 — MICROSPAN HYSTEROSCOPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.