FDA 510(k) clearances — page 975
clearances on record, most recent first.
Clearances — page 975
97,401–97,500 of 176,637- 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
- K962633 — VEGA HEMATOLOGY ANALYZER
- K962668 — AMR-ACV CLAMPS
- K962690 — E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE
- K962987 — EZ-FIX SMALL CANNULATED SCREW SYSTEM
- K963048 — IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
- K963060 — HEELBO SECURITY BELT
- K963061 — IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
- K963095 — TRUPEAK PEAK FLOW METER
- K963187 — MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
- K963402 — INNOVASIVE 2.8MM ROC SUTURE BONE FASTENER AND 3.5MM ROC SUTURE BONE FASTENER
- K963901 — ELECTROSURGICAL PROBE
- K964115 — RESOUND CC4 PERSONAL HEARING SYSTEM
- K943824 — GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
- K961272 — NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
- K961705 — AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM
- K961710 — AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM
- K961836 — MAXIMA FORTE HARDSHELL VENOUS RESERVOIR
- K961935 — SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER
- K962028 — WELLCOLEX E-COLI OI57 ZC60
- K962081 — COMBILINES HEMODIALYSIS BLOOD TUBING SET
- K962083 — KARL STORZ REMORGIDA FORCEPS
- K962482 — SCUBA SYSTEM
- K963025 — SLEEPNET HUMIDIFIER,(84200 PACKAGED)
- K963034 — FEMTEX GENTLE TOUCH TAMPONS
- K963035 — MICRO SPIROMETER
- K963042 — INNOSAN TRAVELAIR S PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853
- K963046 — ENDOCAM
- K963099 — HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET
- K963199 — HEELBO PELVIC RESTRAINT
- K963550 — RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM
- K963911 — ALPCO/MERCODIA INSULIN ELISA
- K964027 — STP SYSTEM-PVA WITH MERCURY
- K964053 — HEMOCUE GLUCOTROL
- K960590 — TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE
- K961361 — ASTA-CATH
- K961364 — AUTOMATIC TUBING CLAMP SYSTEM (ATC)
- K961621 — THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM
- K961645 — MRS-2D
- K961784 — COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS
- K962764 — NEUROMAG-122
- K962993 — CYNOSURE PHOTOAPPEAL CO2 SURGICAL LASERS
- K963041 — HEELBO LIFE JACKET WITH CROTCH SUPPORT
- K963233 — EZ-SCREEN PROFILE
- K963274 — V-LINK 3.2 FOR WINDOWS
- K963292 — COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
- K963393 — MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT
- K963419 — MORRISON MEDICAL WRIST RESTRAINT
- K963527 — UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS
- K963766 — 3M PROPLUS SYSTEM
- K954850 — BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR
- K962726 — BARD QUANTUM CVR
- K962795 — CEDIA DAU OPIATE 2K ASSAY
- K962988 — COULTER GEN-S SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.