FDA 510(k) clearances — page 751
clearances on record, most recent first.
Clearances — page 751
75,001–75,100 of 175,825- K022707 — LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438; LEVEL S2E, MODEL 439
- K013046 — COSMOS SYSTEM
- K021315 — SURE-LOK
- K021528 — REPROCESSED VENODYNE SEQUENTIAL COMPRESSION SLEEVES / WRAP
- K021972 — FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
- K022150 — TRIONOMER
- K022401 — PTS PANELS MULTI-CHEMISTRY CONTROLS
- K022453 — MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
- K022544 — DORNIER MEDILAS H LASER FIBER CABLES
- K022575 — PERFUSOR COMPACT WITH FM SYSTEM
- K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
- K022605 — BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
- DEN020003 — RETROX
- K012931 — GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM
- K013759 — MSS-28CS-301/701 NEEDLESCOPE
- K021686 — LASER FIBER GF500
- K021696 — 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25
- K021717 — ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
- K021745 — VASCLIP
- K022184 — FLASH-LITE LED DENTAL CURING LIGHT
- K022410 — SAPH-LOOP LIGATING LOOP
- K022542 — PHILIPS BABY THERMOMETER SET (SBC SC530)
- K022553 — CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L
- K013958 — INDUS TEXTILES TOWEL-STERILE AND NON-STERILE
- K021724 — DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS
- K021738 — FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES
- K021805 — SEAL & PROTECT PROTECTIVE SEALANT
- K022010 — TOTAL KNEE FEMORAL COMPONENT
- K022460 — SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS
- K011700 — MODULITH SLK LITHOTRIPTER
- K013623 — CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420
- K014210 — PALMO THERMOREGULATION INTERFACE ACCESSORY
- K021650 — ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER
- K021765 — CEMENT RESTRICTOR, SMALL AND LARGE
- K021960 — PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY
- K022407 — MULTI FUCTIONAL REHABILITATION CHAIR
- K022463 — HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS
- K011327 — DB1 EMBRYO FREEZE
- K014270 — MININEPH HUMAN B2-MICROGLOBULIN KIT
- K020537 — TL10 TENSYMETER BLOOD PRESSURE MONITORING SYSTEM
- K021718 — INTRAORAL IMAGING SYSTEM, MODEL SUNI-RAY
- K021719 — FORTITUDE CEMENT RESTRICTOR
- K021747 — DEGALL LAPAROSCOPIC GALLBLADDER EXTRACTOR
- K021751 — ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
- K021776 — KSEA QUADRO SWITCH
- K021887 — CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
- K022025 — MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT
- K022045 — VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID
- K022153 — BLADDERSCAN BVI 6100
- K022333 — SPIFE LIPPOROTEIN-12, MODEL 3344
- K022345 — AUTOPULSE RESUSCITATION SYSTEM
- K022347 — MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES
- K022348 — ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
- K022525 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
- K022529 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669
- K022548 — MEDTEXX BLUE COLOUR POWDER-FREE NITRILE RUBBER EXAMINATION GLOVES
- K022586 — ANTERIOR STABILIZED TIBIAL BEARINGS
- K012523 — REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
- K012678 — REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
- K013038 — SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010
- K013618 — INTRAORAL MANDIBULAR DISTRACTION SYSTEM
- K020290 — DASH 3000/4000 PATIENT MONITOR
- K020597 — SERRALGUT
- K020710 — BIOTEST HEMOGLOBIN MEASURING SYSTEM
- K020984 — ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS
- K021633 — ECAT VISION PET SCANNER, MODELS 3000 & 5000
- K021642 — SYNTHES CRANIOFACIAL PLATES
- K021707 — SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER, SINGLE STEP HOLDERS
- K021792 — BILAYER MATRIX WOUND DRESSING
- K021808 — WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
- K021898 — SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K021904 — MAEDA SILVER ACUPUNCTURE NEEDLE
- K021920 — 7.0 FR. ENDOBRONCHIAL BLOCKER
- K022017 — RHIGENE MESACUP-2 TEST RNP, MODEL M7741
- K022066 — REGISTRADO X-TRA
- K022242 — INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
- K022270 — MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
- K022414 — STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE
- K022425 — SCREWLINE
- K022435 — 507EL VITAL SIGNS MONITOR
- K022486 — K-ASSAY HS-CRP CONTROLS
- K012708 — ELECTROPHYSIOLOGY CATHETER
- K013691 — CERALAS D DIODE LASER SYSTEM, MODEL # D50
- K013828 — GLOVCO EBONY
- K020655 — DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
- K020759 — 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT
- K021573 — PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
- K021599 — 96 CHANNEL EEG HEADBOX MODEL EMU96
- K021631 — ISA-21 INTERVENTIONAL SPINE ARRAY COIL
- K021956 — MHS MED LIGHT 1000
- K021999 — GRIPPER PLUS NEEDLE
- K022074 — SPHERZ
- K022197 — SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
- K022285 — MODIFICATION TO ISOLA SPINAL SYSTEM
- K022328 — EMS PIEZON MASTER 600
- K022337 — 3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D
- K022354 — ULTRAGUIDE CTG 2000SA
- K022372 — HRH-127-8 HEAD ARRAY COIL
- K022395 — 1.5T SCANMED PV ARRAY
- K022482 — SENSA-CUFF, MODELS INFANT, CHILD, ADULT
Data sourced from openFDA. This site is unofficial and independent of the FDA.