FDA 510(k) clearances — page 405
clearances on record, most recent first.
Clearances — page 405
40,401–40,500 of 175,770- K132159 — PROADENO+ ASSAY
- K132200 — PRO HMPV+ ASSAY
- K123061 — ACE MONOPOLAR ATTACHMENT
- K123443 — PRECISE SHP DIODE LASER
- K123473 — HOPER PTCA BALLOON CATHETER
- K123814 — HUMELOCK II CEMENTED SHOULDER SYSTEM
- K123834 — EASYSTAND BANTAM MEDIUM
- K130398 — SOFIA(R) RSV FIA
- K130672 — OPTIFLOW II FLOWABLE COMPOSITE, LC
- K130682 — MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT
- K130887 — S4C NAVIGATION INSTRUMENTS
- K130900 — EVICEL APPLICATION DEVICE
- K131464 — EXTRICARE NPWT FOOT DRESSING
- K123699 — FAHL TRACHEOSTOMY TUBES (MULTIPLE)
- K123864 — GIVEN PILLCAM ENDOSCOPY SYSTEM WITH RAPID 8.0, GIVEN PILLCAM SB 3 CAPSULE ENDOSCOPY SYSTEM
- K123891 — SPARTAN RX CYP2C19 TEST SYSTEM
- K131014 — PANA SPRAY PLUS
- K131032 — PHILIPS SURESIGNS CENTRAL
- K131133 — VIVORTE BVF LITE
- K131532 — ELECTROMAGNETIC TRANSMITTING STYLET
- K131536 — IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
- K132197 — CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETER
- K122562 — E-TENG MODEL EOR 1
- K123076 — PROFTHAND MECHANICAL WHEELCHAIR
- K123553 — ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
- K124014 — SUREFIX INTERSPINOUS FUSION SYSTEM
- K130089 — CROSSTREES PVA POD
- K130484 — MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
- K130685 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
- K130821 — INTEL-GE CARE INNOVATIONS CONNECT RCM
- K130863 — FACET SCREW SYSTEM
- K131029 — ACCU-CHEK AVIVA PLUS TEST STRIP
- K131205 — ARTHROCARE HEAD AND NECK COBLATION WAND
- K131279 — ICONACY I-HIP SYSTEM
- K131415 — LIVE VIEW PANEL (LVP)
- K131419 — ACURA PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM
- K131441 — LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
- K131522 — CORE PEDICLE SCREW SYSTEM
- K132129 — PRODESSE PROFLU+ ASSAY
- K132154 — CAPSURE PS SYSTEM
- K132165 — QLAB QUANTIFICATION SOFTWARE
- K132226 — METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT
- DEN130005 — QUANTITATION OF ORGANOPHOSPHATE METABOLITES IN URINE BY LC/MS/MS
- K121610 — COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY
- K123390 — PEDIGUARD NERVE DETECTOR SYSTEM
- K130179 — MP VIAL ADAPTER 13MM
- K130273 — PANPAC VAGINAL DILATORS
- K130820 — EXPANDABLE LUMBAR INTERBODY SYSTEM
- K130846 — MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN
- K131538 — CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM
- K131674 — PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
- K131694 — NMI PORT II CATHETER
- K131744 — SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SINGLE-NEEDLE CONNECTOR, SPECTRA OPTIA SYSTEM SOFTWARE
- K131759 — METALLIC LOCKING COMPRESSION BONE PLATES AND SCREWS SYSTEM
- K131810 — OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM
- K131869 — PTS-X SIZING BALLOON CATHETER
- K131945 — GE DATEX-OHMEDA AVANCE CS2
- K132090 — BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
- K123904 — PROTHELIAL
- K130148 — FOREIGN BODY HOOD
- K130608 — QUADCUT
- K130932 — FIREBIRD SPINAL FIXATION SYSTEM
- K131313 — ACTIVE BREATHING COORDINATOR
- K131345 — TIARRAY DENTAL IMPLANT SYSTEM
- K131360 — INTEGRA TITANIUM BONE WEDGE
- K131512 — KATIA SYSTEM
- K131642 — RSH BILIARY STONE REMOVAL DEVICE
- K131722 — I.T.S. EXTREMITY FIXATION SYSTEMS
- K132256 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
- K132259 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
- K122337 — OVUSENSE
- K123047 — BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET
- K130046 — CLEARSPEC SINGLE USE VAGINAL SPECULUM
- K130126 — SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM
- K130743 — THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL
- K131450 — FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0
- K131875 — MENICON NECT CONTACT LENS CASE
- K132111 — CD HORIZON SPINAL SYSTEM
- K122553 — MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
- K122610 — PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES
- K122883 — EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
- K130342 — SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
- K130541 — SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
- K131286 — PRIMATRIX DERMAL REPAIR SCAFFOLD
- K131704 — EPIDOSE
- K131930 — JBAIDS ANTHRAX DETECTION KIT
- K132190 — EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOME
- K130748 — SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
- K121370 — VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
- K122063 — INTELLISAVE AX700 ANESTHESIA SYSTEM
- K123347 — NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
- K130933 — SOLUTIS
- K131166 — SOFIA(R) HCG FIA
- K131301 — BD FACS SAMPLE PREP ASSISTANT III
- K131493 — SIDEKICK AND USHER SUPPORT CATHETERS
- K131517 — MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
- K132061 — RESTORELLE M, RESTORELLE XL
- K123399 — MYOVISION 3.0 WIREFREE SYSTEM
- K123571 — CARDIO VISION MICS AORTIC CLAMPS
- K130033 — TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO
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