FDA 510(k) clearances — page 967
clearances on record, most recent first.
Clearances — page 967
96,601–96,700 of 175,890- K963186 — ORTHO 8000
- K963309 — APEX HOLE ELIMINATOR PS
- K963464 — RESTRAINT NET
- K963477 — PEDIATRIC MITTENS
- K963489 — WHEEL CHAIR ACCESSORY
- K963490 — PROTECTIVE RESTRAINT - BELTS
- K963492 — PROTECTIVE RESTRAINT
- K963618 — SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
- K963656 — FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING
- K963812 — LM BONE ANCHOR (ORTHOPEDICS)
- K963905 — RADIOGRAPHIC ITT TABLE
- K963921 — PULPDENT SEAL-RITE UDMA
- K964265 — CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
- K964266 — BIAD NUCLEAR IMAGING SYSTEM
- K964267 — MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
- K964268 — TRIAD 88 NUCLEAR IMAGING SYSTEM
- K954679 — THERAPLAN PLUS
- K961582 — EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100
- K961834 — PHILIPS EASYGUIDE NEURO
- K962068 — LIGHTSTIC MODEL 180
- K962364 — CODONICS MEDICAL PRINTER (NP-1600M,NP1600MD)
- K963098 — PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)
- K963112 — MMG MULTI LUMON EXTENSION SET
- K963124 — PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)
- K963172 — SYNTHES STERILE 4.5 MM CANNULATED SCREWS
- K963192 — SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS
- K963370 — CINCH STRAP WITH BUCKLE
- K963374 — TORSO/WAIST RESTRAINT
- K963387 — DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP
- K963497 — GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
- K963579 — PACE-1A CARDIAC STIMULATOR
- K963617 — SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120
- K963687 — AIA-PACK FT3 ASSAY
- K963909 — HEMOCUE GLUCOLIN
- K963915 — TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION
- K963986 — STP SYSTEM PVA WITH ZINC
- K955110 — NAVARRE PERCUTANEOUS BILIARY DRAINAGE
- K960855 — PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS & PRESTIGE HIGH AND LOW GLUCOSE CONTROL
- K961484 — CASS SYSTEM (MODIFICATION)
- K961593 — INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
- K962180 — CATH SEAL
- K962366 — HEARTPORT CABLE BULLDOG CLAMP
- K963171 — CINCH QR SGW EXTENSION
- K963179 — MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
- K963247 — VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR
- K963371 — BEST STRAP RESTRAINT
- K963372 — HEELBO ER WRIST RESTRAINT
- K963426 — KARL STORZ CONTACT MICRO-LARYNGOSCOPES
- K963513 — CARDIAC STATUS TROPONIN I
- K963525 — DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT
- K963592 — IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000
- K963594 — IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)
- K963628 — IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE
- K963893 — FIBRE INTERSPACED X-RAY GRID
- K964002 — NATURALE HCG PREGNANCY TES
- K964026 — STP SYSTEM - SAF
- K964113 — IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL
- K964263 — EXPERT-KL AND HAND ACQUISITION AND ANALYSIS SOFTWARE
- K961062 — FLEXSURE OBT
- K961292 — WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL
- K961797 — WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE
- K961891 — WLP SINGLE-SEGMENT VERSION WLP SOLO VII
- K962511 — MITEK MICRO ANCHOR
- K963089 — TRUZONE PEAK FLOW METER
- K963117 — P.F.C. CRUCIATE RETAING KNEE SYSTEM
- K963138 — SPIDER STRAP
- K963298 — FIRST AID KIT(S)
- K963399 — MORRISON MEDICAL STRETCHER/COT AND BACKBOARD RESTRAINTS
- K963416 — ANKLE RESTRAINT SYSTEM
- K963431 — POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER
- K963433 — THREADED FIXATION PIN
- K963435 — ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE
- K963494 — MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP
- K963614 — MONOTUBE CARBON TUBE
- K963867 — NEO-CARE CATHETERIZATION TRAY
- K963897 — STERI-OSS SINUS AUGMENTATION KIT
- K963912 — TYCO BABY SESAME STREET SOFT TEETHER
- K964052 — HEMOCUE HEMOTROL
- K964065 — N/T PROTEIN CONTROL SL
- K950853 — OPTIONAL DISPLAY AND SOFTWARE FOR DRAGER VENTILATORS
- K960267 — TBM SPONGE
- K960287 — HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM
- K962089 — DERMAMEND GEL
- K962113 — ANTHOS PHACTS VERSION MICROPLATE READER
- K962559 — ACS CORTISOL IMMUNOASSAY
- K963121 — FIXTURE MOUNT KIT
- K963229 — SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS
- K963401 — TPS APICAL IMPLANT
- K963815 — REUSABLE TROCAR WITH SLEEVE (COMMON)
- K964000 — BISFIL 2B
- K964051 — NEEDLE, ACUPUNCTURE
- K964140 — GLUMA CONDITIONER
- K955122 — INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
- K955274 — BOOSTER LITE 3 MOTORIZED SCOOTER
- K955275 — BOOSTER TROPHY 5 MOTORIZED SCOOTER
- K955276 — BOOSTER LITE 4 MOTORIZED SCOOTER
- K955854 — LIFEPAK 500
- K961668 — MICROFERRET CATHETER
- K961895 — FLEXILOG LS 13921
- K962584 — ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE
Data sourced from openFDA. This site is unofficial and independent of the FDA.