FDA 510(k) clearances — page 785
clearances on record, most recent first.
Clearances — page 785
78,401–78,500 of 176,637- K013407 — AT HOME DRUG TEST, MODEL 9084
- K013408 — AT HOME DRUG TEST, MODEL 9079
- K013409 — AT HOME DRUG TEST, MODEL 9074
- K013410 — AT HOME DRUG TEST, MODEL 9064
- K013412 — AT HOME DRUG TEST, MODEL 9069
- K013650 — ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD
- K013659 — MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM
- K013683 — MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
- K013761 — MEDLINE EXCEL RECLINCER WHEELCHAIR
- K013789 — EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
- K013861 — MODIFICATION TO LEKSELL SURGIPLAN WITH ATLASPACE
- K012014 — MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM
- K012324 — ACCU-CHEK ACTIVE TEST SYSTEM
- K012988 — HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
- K013000 — MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520
- K013112 — FOCAL SIM
- K013211 — MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS
- K013323 — TCI-31 LIFELONG OVULATION TESTER
- K013630 — ISITE RADIOLOGY
- K013658 — MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
- K013660 — GENETRA
- K013663 — CEMENT RESTRICTOR
- K013676 — TRIDENT HEMISPHERICAL ACETABULAR SHELLS
- K013688 — MODIFICATION TO XIA SPINAL SYSTEM
- K013818 — AUTOGENESIS AUTOMATOR, MODEL M1000
- K002113 — CTXA HIP; CTXA; QCT PRO CTXA HIP
- K011393 — RANDOX PHENYTOIN
- K011845 — MILLCOMP
- K011958 — CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT
- K013013 — MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR.
- K013024 — SELECTIVA GUIDEWIRE
- K013638 — MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
- K010166 — IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM
- K011144 — LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR
- K011500 — MENTOR CONTOUR PROFILE TISSUE EXPANDER
- K012025 — MACROPORE SURGIWRAP (TS)
- K012071 — ENT LASERVISION
- K012258 — COMPANION MODEL 221, 321, 421
- K012268 — TRIMAX
- K012380 — MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY
- K012469 — RESORBABLE NO PROFILE SCREW AND WASHER
- K012572 — SOFT TISSUE SCREW AND WASHER
- K012945 — SYNTHES 2.4 MM CANNULATED SCREW
- K012968 — APPLIED ACCESS SEAL
- K013044 — SYNTHES 3.9 MM PELVIC SCREWS
- K013231 — AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L
- K013287 — NIPRO SAFELET CATH
- K013288 — NON-STERILE POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH ALOE VERA AND VITAMIN E
- K013328 — REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600
- K013413 — MICROMARK II TISSUE MARKER,MODEL C1535
- K013502 — SIMPLICITY CLASSIC WING QD INFUSION SET
- K013624 — MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I
- K013657 — MODIFICATION TO: BIOMET HUMERAL CABLE PLATES
- K013661 — XPLAN 2.2 WITH THE BODY SYSTEM
- K013772 — MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
- K013849 — TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS
- K013928 — PAIN CARE 3200
- K011043 — OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
- K011479 — ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
- K011684 — INFLUENZA A/B RAPID TEST, CAT NO 2158 663
- K012115 — SERIM BLOOD LEAK TEST STRIP-2
- K012483 — AMEDITECH IMMUTEST DRUG SCREEN OPIATES
- K012484 — AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE
- K012521 — BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
- K012582 — AMEDITECH IMMUTEST DRUG SCREEN PCP
- K012953 — GIOTTO IMAGE
- K013331 — LYMPHA PRESS PLUS DEVICE
- K013501 — IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
- K013536 — EMTRAC; DELPHIN; SEMTRAC 2000 SET
- K001121 — OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
- K011308 — MULTISTIM
- K012359 — TINA-QUANT COMPLEMENT C4 TEST SYSTEM
- K012361 — TINA-QUANT COMPLEMENT C3C TEST SYSTEM
- K012941 — DRYSTAR, MODEL 4500M
- K012991 — NEPTUNE WASTE MANAGEMENT STSTEM
- K013049 — NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
- K013117 — RESECTION ABLATOR
- K013261 — MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE
- K013264 — MICRO STAMPING LIGATING CLIP
- K013324 — HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT
- K013427 — MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A
- K013432 — IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G
- K013443 — POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2
- K013489 — KP + LFM
- K013845 — MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE
- K010366 — DISPOSABLE STORAGE CAP
- K010607 — MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
- K011909 — ULTRA-THIN SDS BALLOON DILATATION CATHETER
- K012908 — BIOPLATE RESORBABLE BONE SCREW
- K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
- K012920 — MOLDED CRANIAL HELMET
- K013185 — TCM ENDO III
- K013199 — PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B
- K013472 — TOTAL O2
- K013581 — CORDIS AVIATOR PERIPHERAL DILATATION CATHETER
- K013682 — MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM
- K013696 — SILMED NASAL SEPTAL BUTTON
- K010771 — PERIOLASE ND:YAG DENTAL LASER SYSTEM
- K012070 — ORALLITE COMPREHENSIVE EXAM TRAY
- K012516 — EBI SPINELINK - II SPINAL FIXATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.