FDA 510(k) clearances — page 428
clearances on record, most recent first.
Clearances — page 428
42,701–42,800 of 175,770- K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
- K120560 — TRINITY WRINKLE REMOVER
- K120659 — HU-FRIEDY DENTAL CARTRIDGE SYRINGE
- K122187 — VRESELECT CULTURE MEDIUM
- K122998 — BLUE POWDERED NITRILE EXAMINATION GLOVE
- K120280 — RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
- K121434 — SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO
- K121509 — TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT
- K121562 — ALTIS SINGLE INCISION CLING SYSTEM
- K121692 — MINIME 2 NASAL MASK
- K121786 — DYMAXEON SPINE SYSTEM
- K121858 — THE ABLATION SYSTEM
- K122058 — FLEXIPORT ECOCUFF
- K122425 — VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT
- K122512 — CS2 HIP SYSTEM
- K123182 — OSOM INFLUENZA A&B TEST MODEL 190
- K112396 — IUI CATHETERS
- K112735 — TAMARIN BLUE PTCA RX DILATATION CATHETER
- K120555 — LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE)
- K120642 — RESUSCITAIRE WITH AUTOBREATH
- K120909 — EC 2.7 ENDOSCOPIC CUTTER
- K121026 — FLO-GUARD BREATHING FILTER
- K121200 — FLIGHTPLAN FOR LIVER
- K121213 — VITREAADVANCED
- K121539 — XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
- K121878 — CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
- K122192 — NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM
- K122367 — BARD PTV DILATATION CATHETER
- K122389 — TRUSCULPT
- K122401 — TANGO M2 BLOOD PRESSURE MONITOR
- K122436 — COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM
- K122636 — REVELATION POROUS COATED HIP STEM, SIZE 8
- K122646 — DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
- K122938 — FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
- K123021 — BIOPLEX 2200 EBV IGM KIT
- K123179 — AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING
- K123185 — DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
- K123267 — SURFFLASH(R) PLUS SAFETY I.V. CATHETER
- K112700 — FRONTIER SADL INTERBODY FUSION DEVICE
- K120350 — EXTENDED LIFE BATTERY
- K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
- K121560 — LEVANT, HOMEGLIDE
- K121793 — AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
- K122115 — COLLAGEN DENTAL WOUND DRESSINGS
- K122294 — PRESSURIZED INFUSION PUMP
- K122350 — TAP PAP NASAL PILLOW MASK
- K122496 — AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
- K122637 — LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
- K112121 — ERGOSELECT/GE
- K113602 — AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
- K121732 — CANOPY LAMINOPLASTY FIXATION SYSTEM
- K121768 — COSENSE
- K121862 — REX ANTERIOR CERVICAL PLATE SYSTEM
- K122078 — LOFRIC PRIMO, LOFRIC HYDRO-KIT
- K122130 — WINX SLEEP THERAPY SYSTEM
- K122163 — CERTEX SPINAL IMPLANT SYSTEM
- K122313 — STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM
- K122314 — QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY
- K122395 — DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS
- K122434 — MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
- K122478 — MODIFIED TREVO RETRIEVER
- K122876 — MULTIFLEX TINNITUS TECHNOLOGY
- K121973 — BIOPRO HEMI-EDGE TOE SYSTEM
- K111588 — LEGACY-500
- K112139 — THE CANARY SYSTEM
- K113786 — SPERMFREEZE SOLUTION
- K120127 — SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM
- K120406 — ZOLL FULLY AUTOMATIC AED PLUS
- K120796 — SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
- K120930 — CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING
- K121201 — SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS
- K121561 — FLOW2, SWING
- K121781 — ECHONAVIGATOR RELEASE 1
- K122003 — RENEW INSERT
- K122137 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM
- K122215 — NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)
- K122325 — SKINTEMP II
- K122446 — LIQUIDBAND FLOW CONTROL
- K122472 — VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
- K122642 — ABL90 FLEX
- K122985 — COLUMBUS REVISION KNEE SYSTEM
- K123001 — ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM
- K123024 — TORQUE DEVICE
- K113020 — IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
- K120785 — OMNI 3 OXYGEN SYSTEM
- K120869 — ANCHOR-L LUMBAR CAGE
- K121594 — COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)
- K121637 — AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE
- K121921 — INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS
- K121993 — SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT
- K122262 — ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM
- K122299 — SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR GRASPER WAVY RATCHETED, SPIDER SURGICAL INSTRUMENTS, FLEXIBLE MONOPOLAR
- K122694 — GE 8CH FOOT ANKLE COIL
- K122712 — DIGITAL ELECTROCARDIOGRAPH
- K122956 — FUSELOX LUMBAR INTERBODY FUSION DEVICE
- K122969 — CLICKFINE PEN NEEDLE
- K122971 — CLICKFINE PEN NEEDLE
- K122987 — STEALTH 360 ORBITAL PAD SYSTEM
- K123043 — IRMA C02 MODEL 200101; IRMA AX 200601
- K123141 — ENSEAL TRIO TISSUE SEALING DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.