FDA 510(k) clearances — page 754
clearances on record, most recent first.
Clearances — page 754
75,301–75,400 of 175,825- K020004 — CLINDATALINK VERSION 1.0 FOR SPIROMETRY
- K020103 — PRISMAFLO
- K020828 — CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM
- K021322 — ENDOSSOUS IMPLANTS
- K021376 — DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
- K021458 — SYNTHES IN-SITU BENDER/CUTTER
- K021466 — CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE
- K021499 — CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
- K021517 — ABP FOR WINDOWS
- K021705 — MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
- K021784 — PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
- K022073 — HEARTLINE RECEIVING STATION
- K022120 — MPF ACETABULAR CUP GENERATION 2
- K022190 — MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
- K011741 — CRIT-LINE MONITOR III TQA (CLM TQA)
- K012770 — INFINITY MICRO2+
- K012974 — PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007
- K020356 — ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
- K020474 — MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95
- K021114 — 'RAPIDTEC' 5A MULTIPLE DIP TEST
- K021304 — PROLITE PULSED LIGHT SYSTEM
- K021516 — DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
- K021681 — MICROPAQ, MODELS 402, 404
- K021685 — VENTURE HOMEFILL II WITH OXYGEN CONSERVER
- K021764 — RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
- K021822 — R120 MODULAR TOTAL HIP SYSTEM
- K022046 — VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL
- K022148 — INJEX 30 NEEDLE FREE INJECTION SYSTEM
- K022171 — ACCU-CHEK COMPACT SYSTEM
- K020119 — VECTORSONIC, MODEL VU-200
- K020172 — OPUS MAGNUM ANCHOR & INSTRUMENT SET
- K020247 — COLORADO 2 SPINAL SYSTEM
- K020986 — MASTERGRAFT RESORBABLE CERAMIC
- K021313 — SEARCH EVOLUTION TOTAL KNEE SYSTEM
- K021461 — ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM
- K022027 — CALIBRATING MATERIAL, BUFFERS, STANDARD
- K022070 — XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
- K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
- K011591 — ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
- K013420 — CHEMWELL, ALSO KNOWN AS PROJECT 2900
- K014256 — KOLIBRI IGS SYSTEMS
- K020910 — SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
- K021279 — DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE
- K021437 — SECURE SOFT
- K021475 — BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET
- K021524 — LIGHT CURE DENTAL DAM
- K021572 — SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON SYSTEMS CX C-RP CALIBRATOR
- K021671 — JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
- K021844 — ADMIRA PROTECT
- K022000 — POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)
- K022026 — MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)
- K022033 — STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH THE BIOPLATE TITANIUM FIXATION SYSTEM
- K022049 — MODIFICATION TO RAICHEM CALCIUM REAGENT
- K012574 — REPROCESSED FEMORAL COMPRESSION DEVICE
- K013926 — QIZHOU ACUPUNCTURE NEEDLE
- K020409 — STEAMPLUS STERILIZATION TEST
- K021275 — MICOMED POSTERIOR DOUBLEROD SYSTEM
- K021326 — VIDAS TESTOSTERONE (TES), MODEL 30 418
- K021809 — V-2100G ADVANCED INFANT INCUBATOR
- K021990 — GALT MEDICAL GUIDEWIRE
- K021991 — MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE
- K022015 — MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
- K022165 — THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM, MODEL UV120-2
- K013906 — HLS NOETOS SYSTEM
- K020413 — MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML)
- K020616 — BAYER RAPIDPOINT 405 SYSTEM
- K021236 — SURGERY AND ACCESSORIES
- K021254 — LACTOSORB MINI INTERFERENCE SCREW
- K021280 — INION HEXALON BIODEGRADABLE ACL/PCL SCREW
- K021321 — WRIST FUSION PLATE
- K021383 — ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
- K021526 — ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
- K021636 — ALBUMIN REAGENT
- K021778 — PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B
- K021851 — DIGITAL CLINICAL THERMOMETER, MODEL KD-193
- K021967 — HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2
- K012018 — BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910
- K012437 — DEVILBISS SLEEP RECORDER MODEL # RM60
- K013843 — AUTOSET SPIRIT CPAP SYSTEM
- K014246 — AVID-NIT NERVE STIMULATION NEEDLES
- K020005 — INFANT FEEDING TUBES
- K021356 — THE DIVACUP MENSTRUAL SOLUTION
- K021438 — INSEMINATION CATHETER, MODEL 320301
- K021505 — ONLINE DAT II METHADONE II
- K021512 — COBAS INTEGRA ONLINE DAT II METHADONE II
- K021515 — EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
- K021736 — BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
- K021820 — AART SILICONE CARVING BLOCK
- K021839 — AART GLUTEAL IMPLANT
- K021849 — TAGG DISPOSABLE VAGINAL SPECULUM
- K022013 — LUNGCARE CT SOFTWARE PACKAGE
- K022041 — LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
- K022083 — HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
- K022149 — CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
- K022152 — HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
- K012543 — VISION SCIENCES ENDOSHEATH SYSTEM
- K013713 — ARM AUTOMATIC REPROCESSING MACHINE
- K020968 — LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD
- K021520 — EMT-CPAP
- K021592 — PHFW-10
Data sourced from openFDA. This site is unofficial and independent of the FDA.