FDA 510(k) clearances — page 672
clearances on record, most recent first.
Clearances — page 672
67,101–67,200 of 175,825- K041747 — IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)
- K042043 — FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5
- K042089 — NX STAGE WATER PURIFICATION SYSTEM
- K042133 — DRY LASER IMAGER, MODEL DRYPRO MODEL 793
- K042264 — GUIDEWIRES
- K042340 — KASIOS TCP
- K042353 — AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS
- K042400 — MUCOTROL CONCENTRATED ORAL GEL WAFER
- K042443 — SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL
- K042466 — X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE
- K042769 — ADSEAL ROOT CANAL SEALER
- K042806 — QUADRANT UNIT-1-BOND
- K042859 — KOBRA GPS FIXATION SYSTEM
- K042865 — LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
- K042960 — GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO
- K042968 — MCL 30 DERMABLATE ER:YAG LASER SYSTEM
- K042995 — X-LEONARDO
- K042996 — COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE
- K043052 — TRIGEN HINDFOOT FUSION NAIL
- K043096 — COMMANDER II
- K043112 — GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM
- K043175 — ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
- K031568 — BICONITE SURFACE TREATMENT
- K033146 — TONO-PEN TONOMETER TIP COVER
- K041142 — RANDOX CANNABINOIDS ASSSAY
- K041388 — COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
- K041746 — IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE)
- K041882 — FLOWCARE SYSTEM
- K041926 — HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
- K041927 — LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
- K041928 — HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
- K041978 — REPROCESSED DIAMOND BURS
- K042544 — UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
- K042640 — UNI-THREAD SPINAL SYSTEM
- K042665 — SMART BITEBLOC
- K042702 — SILHOUETTE SPINAL FIXATION SYSTEM
- K042773 — ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS
- K042872 — RONDOFLEX PLUS 360
- K042883 — SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT
- K042987 — MODIFICATION TO SYNTHES CRANIAL PLATES
- K043061 — THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4316-XX-XX
- K043082 — THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM
- K043095 — ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
- K031402 — PERFECTA FEMORAL STEM
- K033033 — VIZILITE-BLUE ORAL EXAM KIT
- K040708 — STATUS FIRST STREP A
- K041242 — CANDELA SMOOTHBEAM LASER SYSTEM
- K041284 — MEDICULT IVM SYSTEM
- K041470 — MORTON IUI CATHETERS
- K042152 — BINDING SITE IGG SUBLCASS OLYMPUS KITS
- K042314 — SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE
- K042491 — BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER
- K042614 — S&C-SELF ETCH PR-BOND
- K042662 — NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM
- K042746 — PET-DOSE
- K042812 — BBLCHROMAGAR MRSA
- K042848 — FRC POSTEC PLUS
- K042910 — VENTURE WIRE CONTROL CATHETER, MODEL WCC
- K042918 — MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2
- K042942 — MGP 15 DICOM THEATER
- K042953 — MODIFICATION TO PROTEX STABILIZATION SYSTEM
- K042964 — MX MONOAXIAL PEDICLE SCREW
- K043138 — PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
- K041817 — WEST NILE DETECT IGM ELISA
- K042127 — SMITH & NEPHEW MODULAR HIP
- K042227 — INSTANT-VIEW TROPONIN I TEST
- K042347 — MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD
- K042390 — ETEST FOR GEMIFLOXACIN
- K042473 — COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
- K042477 — VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN
- K042601 — CAPNOSTAT 5
- K042660 — NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
- K042661 — NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM
- K042671 — PLANMED SOPHIE NUANCE CLASSIC
- K042680 — RHIGENE HEP-ANA TEST SYSTEM
- K042697 — SECOND LOOK VIEWER
- K042731 — ARCHITECT CA 125 II ASSAY
- K042894 — IMALUX NIRIS IMAGING SYSTEM
- K042897 — AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
- K042906 — AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101
- K042922 — VENTURE ANTERIOR CERVICAL PLATING SYSTEM
- K042966 — DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H
- K043025 — SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250
- K043097 — 3VISEON
- K032315 — IOP8 INTRA OPERATIVE PROBE
- K034005 — SDS-4I
- K041172 — BASBA E-MACHINE
- K041869 — SELF RETAINING BICANALICULUS INTUBATION SET
- K042076 — FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5
- K042348 — GRADIA DIRECT LOFLO
- K042365 — SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM
- K042521 — VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS
- K042625 — QUIKREAD CRP CALIBRATOR SET
- K042643 — VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II
- K042685 — METRICATH SYSTEM
- K042694 — ADVANCED LUNG ANALYSIS II
- K042786 — BEST MODEL # 81-01 SERIES IR-192 SOURCES
- K042876 — URS LP DIGITAL, MILLENNIUM, RADPRO
- K042881 — PMD-2000 INTERFERENTIAL STIMULATOR
- K042886 — CD HORIZON SPINAL SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.