FDA 510(k) clearances — page 854
clearances on record, most recent first.
Clearances — page 854
85,301–85,400 of 175,890- K991540 — WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
- K991947 — 3I CERAMIC ABUTMENT SYSTEM
- K992079 — KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325
- K992141 — OLYMPUS WORKING ELEMENT FOR PROBES
- K992352 — ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
- K992378 — DIAGNOSTIC ULTRASOUND, MODEL 1.0
- K992622 — INTRAMAX ITI GUIDE CATHETER
- K992728 — SPRING POWERLITE 2000
- K992736 — WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
- K992968 — CARTO EP NAVIGATION SYSTEM
- K990500 — KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
- K992385 — ORTHOPANTOMOGRAPH OP100D
- K992680 — ELECSYS PARATHYROID HORMONE TEST SYSTEM
- K992798 — SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P
- K992800 — SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P
- K992801 — SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5
- K993188 — ENDOSTEPPER 1
- K991667 — BROADLINE OR TOWELS
- K992117 — PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER
- K992420 — MODIFICATION OF PASCO MIC AND MIC/ID PANELS
- K992558 — NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE
- K992810 — HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE
- K984210 — SILVERLON WOUND PACKING STRIPS
- K990253 — SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600
- K990662 — DISPOSABLE HEATING TUBING SET #7642HSES
- K990816 — AVCORE SYSTEM
- K990900 — MICROKERATOME, MODEL MK-2000
- K990931 — EZ-HBT HELICOBACTER BLOOD TEST
- K991090 — PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3)
- K991378 — PHOSPHATE BUFFERED SALINE (PBS), PHOSPHATE BUFFERED SALINE WITH CALCIUM, MAGNESIUM, GLUCOSE, PYRUVATE AND PHENOL RED
- K991381 — PURECEPTION LOWER PHASE, PURECEPTION UPPER PHASE, PURECEPTION WITH HEPES-BUFFERED HAM'S F-10 AND HSA
- K991620 — VISINE FOR CONTACTS
- K991633 — QUICKVUE INFLUENZA A/B TEST
- K991800 — HEMOCHEK URINE COLLECTION KIT
- K992175 — EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
- K992250 — CORE AUDIBLE TROCAR II
- K992432 — BACT/ALERT FN
- K992444 — MODIFICATION OF: CELL-DYN 1200 SYSTEM
- K992517 — BIOCHECK FERRITIN ELISA MODEL BC-1025
- K992526 — FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE
- K992572 — NTERO RF SLEEVE
- K992594 — A-15 HEMODIALYZER
- K992671 — QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES
- K992686 — DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR
- K992687 — MILLENIUM MICROKERATOME, MODEL IMD-001
- K992860 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
- K992876 — VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
- K992882 — LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM, VIEW SCOPE, SURGISCOPE,ELEKTA INSIGHT
- K992946 — RENEW RECEIVER
- K992972 — ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, ARTHROCARE ELECTROSURGERY WAND, MODELS H2000
- K992981 — ELECSYS ESTRADIOL CALSET II
- K992986 — SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER
- K992988 — PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM
- K972833 — E100M VENTILATOR (E100M)
- K990241 — ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP
- K990660 — NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX
- K990960 — PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
- K991551 — VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE
- K991646 — AGILITY STEERABLE GUIDEWIRE
- K992026 — SORING GMBH, SONOCA 300
- K992153 — PE-PLUS ACETABULAR CUP
- K992159 — SURGISIS SLING
- K992168 — MOSS MIAMI 6.35MM POLYAXIAL SCREW
- K992270 — MIRACLEBREATH TONGUE CLEANER
- K992282 — MICRO-FRANCE LIPOSUCTION CANNULAS
- K992348 — SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
- K992367 — EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS
- K992474 — ARTHROSCOPE / MEDIFIX INC.
- K992480 — MEDIFIX SINGLE AND DOUBLE PUNCTURE LAPAROSCOPES
- K992565 — A-18 HEMODIALYZER
- K992577 — PHOTON RADIOSURGERY SYSTEM (PRS)
- K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM
- K992938 — ROTORBLADE SUTURE ANCHOR
- K991209 — ORAL SLEEP DISORDER AID
- K991398 — BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT
- K991577 — NIC TONE ACRYLIC RESINS
- K992144 — BIOPRO RIMMED ACETABULAR COMPOMENT
- K992161 — CERANA
- K992306 — SAMSUNG RAYPAX DISPLAY WORKSTATION
- K992350 — PYLON INTRAMEDULLAARY NAIL SYSTEM
- K992364 — HEALTH-PLUS, SANITEX, RELIANCE POWER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM 73.13 MICROGRAMS O
- K992374 — AURORA HL
- K992405 — AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)
- K992518 — PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
- K992609 — HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400
- K992611 — MITEK ROTATOR CUFF QUICKANCHOR PLUS
- K992645 — SINFONY
- K992705 — CERADIUM NON-PRECIOUS CERAMIC ALLOY
- K992951 — CONVERTORS SURGICAL GOWNS
- K993069 — GE DIASONICS GATEWAY AND GATEWAY FX
- K991045 — MINI-LOGGER SERIES 2000
- K991062 — QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024
- K991063 — QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024
- K991319 — RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS
- K991399 — RADIONICS MICROELECTRODE KIT
- K992199 — ACID HEMOGLOBIN KIT
- K992296 — PASCO MIC AND MIC/ID PANELS, VANCOMYCIN
- K992423 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
- K992440 — AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA
- K992487 — MITEK MINI QUICKANCHOR PLUS
Data sourced from openFDA. This site is unofficial and independent of the FDA.