FDA 510(k) clearances — page 427
clearances on record, most recent first.
Clearances — page 427
42,601–42,700 of 175,770- K121977 — PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM
- K122229 — VICEROY SPINAL SYSTEM
- K122443 — UFIT TEN-10
- K122454 — FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
- K122467 — 3M TRUE DEFINITION SCANNER
- K122488 — AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES
- K122573 — HI-TORQUE COMMAND GUIDE WIRE FAMILY
- K122596 — ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS
- K122606 — PHT-6500; PHT-60CFO; PAX-I3D
- K122772 — PENUMBRA DDC CATHETERS
- K122931 — S-LOK PSS SYSTEM
- K123039 — CDI BLOOD PARAMETER MONITORING SYSTEM 500
- K123198 — LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA
- K123229 — REMOTE PRESENCE SYSTEM, MODEL RP-VITA
- K123297 — COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM
- K123375 — SYNGO.VIA
- K123409 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
- K113567 — SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
- K120617 — PTFE SUPER SHEATH INTRODUCER
- K120711 — NON-CONTACT THERMOMETER
- K121100 — VITEK 2 AST STREPTOCOCUS VANCOMYCIN
- K121494 — LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING
- K121791 — ZOU ANTERIOR LUMBAR PLATE SYSTEM
- K122333 — MOBILECARE MONITOR
- K122356 — ALIVECOR HEART MONITOR FOR IPHONE
- K122440 — RESTORELLE L
- K122538 — ACUMED PELVIC BONE PLATE SYSTEM
- K122699 — SENTRYSUITE PRODUCT LINE
- K113113 — ENDOSSEOUS DENTAL IMPLANT
- K113344 — STEREOS WORKSTATION
- K120066 — POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
- K121151 — PRO-LINK CERVICAL SPACER SYSTEM
- K121225 — HAMILTON-C2
- K121792 — NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM
- K122008 — INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
- K122129 — SPHYGMOCOR XCEL
- K122171 — MS SA IMPLANT SYSTEM
- K122174 — PEDIATRIC POSITIONER PAD SET
- K122236 — VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER
- K122526 — 360 GAS ASSISTED ENDOSCOPIC APPLICATOR
- K122529 — ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
- K122686 — ACCU-CHEK ULTRAFLEX INFUSION SET
- K122729 — ABL90 FLEX
- K123026 — TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO
- K123174 — CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
- K123246 — CD HORIZON SPIRE Z SPINAL SYSTEM
- K113380 — PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
- K113728 — SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
- K121857 — FEMMYCYCLE
- K122011 — NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP
- K122090 — SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
- K122886 — NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING
- K122899 — POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
- K122904 — WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;
- K123259 — MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM
- K122860 — KLS MARTIN RECON TALON
- K112830 — ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)
- K120857 — EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
- K122180 — HIGH FLOW INSUFFLANTION UNIT
- K122324 — VPAP S-A
- K122662 — VERTIFLEX DIRECT DECOMPRESSION SYSTEM
- K123056 — PASCAL LASER INDIRECT OPHTHALMOSCOPE
- K123068 — OPTIMA MR 430S
- K123214 — ENCORE 26 ADVANTAGE KIT
- K112091 — H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
- K112853 — VOLTERA POWERED SUCTION PUMP
- K113124 — ALN OPTIONAL VANA CAVA FILTER
- K113314 — PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
- K120888 — PSG-1100 SLEEP DIAGNOSTIC SYSTEM
- K121354 — MICRO/MINI N-PK(F) BONE ANCHOR
- K121356 — MICRO/MINI N-PK(H) BONE ANCHOR
- K121599 — CRIT-LINE CLIP (CLIC)
- K121891 — NEWPORT AURA VENTILATOR
- K122122 — REGEN SPRAY APPLICATOR,
- K122405 — AIR-BAND RADIAL COMPRESSION DEVICE
- K122580 — AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES
- K122765 — PERSONA NATURAL TIBIA BASEPLATES
- K113066 — CORVIS ST
- K113316 — DCS LACRIMAL STENT
- K113601 — AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
- K120479 — MTF FASCIA
- K120873 — ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM
- K121607 — TERUMO(R) NEEDLE
- K122795 — STINGRAY GUIDEWIRES
- K112877 — COMEN MULTI-PARAMETER PATIENT MONITOR
- K120508 — CLEARLUMEN THROMBECTOMY SYSTEM
- K121277 — Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
- K121725 — PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
- K121771 — ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
- K121814 — ENCORE TONGUE SUSPENSION SYSTEM
- K122278 — BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR
- K122380 — OCELOT SYSTEM
- K122689 — INOBLENDER
- K122738 — GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
- K122857 — HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
- K122912 — DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)
- K122959 — HAMMER TOE IMPLANT
- K123268 — SMARTSTITCH PERFECTPASSER SYSTEM
- K112599 — INSURGICAL SINGLE USE POWER EQUIPMENT
- K113225 — NYLUS PICC
Data sourced from openFDA. This site is unofficial and independent of the FDA.