FDA 510(k) clearances — page 824
clearances on record, most recent first.
Clearances — page 824
82,301–82,400 of 175,890- K001323 — NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
- K001375 — ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
- K001608 — BLAINE SCARCARE PATCH
- K001942 — SL-PLUS AND SLR-PLUS STEMS
- K001957 — MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
- K001989 — COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
- K002115 — A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS
- K000580 — ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
- K001032 — RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
- K001391 — BONUS MECHANICAL WHEELCHAIR
- K001407 — SURGITRON IEC II
- K001558 — SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)
- K001777 — MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
- K001890 — SHERPA/KODIAK CUB MOBILITY SYSTEM (MANUAL WHEELCHAIR)
- K001929 — WAKO AUTOKIT LP(A) AND LP(A) CALIBRATOR/COBAS FARA
- K001931 — WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET
- K001933 — WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/COBAS BIO
- K001934 — WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/BECKMAN CX
- K002071 — SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES
- K002093 — ATRIUM LITE MESH
- K993706 — ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
- K994158 — MACROSORBOS PROTECTIVE SHEET
- K001919 — WAKO AUTOKIT LP(A)/DADE DEMENSION
- K001920 — WAKO AUTOKIT LP(A)/ RA,500/1000,
- K001921 — WAKO AUTOKIT LP(A)/EXPRESS 550
- K000610 — RESOLUTION CHOLESTEROL MONITOR
- K001050 — CALCIJECT
- K001317 — ARIA
- K001390 — BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
- K001423 — KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
- K001424 — KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
- K001426 — KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
- K001446 — LIGHT-CURED ORTHODONTIC BAND CEMENT
- K001530 — THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
- K001541 — MINICAM
- K001750 — MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM
- K001876 — TAKE 1 BITE
- K002046 — MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100
- K992414 — PROTON BEAM THERAPY SYSTEM (PBTS)
- K994141 — CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000
- K001087 — PTA BALLOON CATHETER
- K001288 — DR180-II
- K001306 — STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX
- K001318 — CPAP SYSTEM, MODEL 102001
- K001357 — MODIFICATION TO OMEGA 21 SYSTEM
- K001376 — TI-MAX PROTRUSIO CAGE
- K001864 — SYNTHES CERVIFIX SYSTEM
- K001885 — VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
- K001930 — MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
- K001932 — TORNIER CEMENT RESTRICTOR
- K001966 — REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND
- K002126 — ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
- K991279 — MEDI-CULT UNIVERSAL IVF-MEDIUM
- K993205 — BOOKER BOX, MODEL PAD 5010
- K000869 — LA PERSONAL SCOOTER
- K000944 — THERMAGE THERMACOOL SYSTEM
- K001361 — JILCO TRACTION-FLEXION CHAIR
- K001511 — O-LAS OPHTHALMIC PHOTODISRUPTOR
- K001630 — KSEA BIPOLAR COAGULATING ELECTRODES
- K001716 — REDON SET
- K001723 — COOL-TEC ELECTRODES
- K001746 — LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)
- K001751 — MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
- K001752 — MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
- K001754 — MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM
- K001844 — MODIFICATION TO CENTAUR SPINAL SYSTEM
- K001936 — ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD
- K002084 — MICROVASIVE LITHOTRIPTOR FLEXPROBE II
- K993420 — CONTROL SOLUTIONS INC, MODEL CS3101
- K993684 — SPINAL PAD
- K993909 — NANMA VACUUM PUMP
- K994214 — GEM KNEE SYSTEM
- K001298 — J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR
- K001359 — DASH 3000/4000 PATIENT MONITOR
- K001450 — AUTO SUTURE MICRO SURGICLIP CLIP APPLIER
- K001573 — SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
- K001612 — PASCO MIC AND MIC/ID PANELS
- K001843 — S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K001964 — OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
- K992182 — CA GUARD, LTD. PSP (PORT SITE PROTECTOR)
- K993328 — SURGILIGHT, INC EXCIMER LASER
- K993685 — BIOPACK
- K993686 — LIGHT PATCH
- K001236 — RIZA BAND STRETCHER (RBS)-60000
- K001268 — GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS
- K001276 — MEDICAL IMAGE MERGE (MIM)
- K001296 — SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM
- K001328 — INTRODUCER SHEATH
- K001362 — KARL STORZ 3D VIDEO SYSTEM
- K001370 — ACCUSONIC PLUS, MODEL AP-100
- K001386 — ACCUSET SENSOR, MODEL 2000
- K001582 — LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE
- K001698 — MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159
- K001730 — GC FUJICEM
- K001904 — ARTHROCARE FLOW CONTROL UNIT
- K993996 — UNIVEC AUTO-DISABLE HYPODERMIC SYRINGE
- K994018 — PHARMASEED, MODEL BT-125-3
- K001271 — SAMARCO SPIDER PLATES
- K001924 — COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0
- K994016 — PHARMASEED, MODEL BT-103-3
Data sourced from openFDA. This site is unofficial and independent of the FDA.