FDA 510(k) clearances — page 739
clearances on record, most recent first.
Clearances — page 739
73,801–73,900 of 175,825- K024041 — ZETAPLUS SOFT
- K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
- K024108 — SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM
- K020683 — ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
- K022028 — VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER
- K022177 — PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K022185 — UNIVERSAL CMF SYSTEM
- K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
- K023091 — ST AIA-PACK TESTOSTERONE ASSAY
- K023094 — IRIDIS OPHTHALMIC PHOTOCOAGULATOR
- K023112 — PROSOLV CARDIVASCULAR VIEWER; ANALYZER; SERVER; VERSION 2.5.9
- K023132 — JOSTRA MECC SYSTEM
- K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE
- K023185 — ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800
- K023539 — STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW
- K023560 — ENVIRON-NP DISPOSABLE VINYL EXAM GLOVES, POWDERED
- K023867 — MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3
- K023894 — ST AIA-PACK AFP ENZYME IMMUNOASSAY
- K023986 — ARTHREX OPES ELECTRODES AND ACCESSORIES
- K020482 — KERATOME BLADE 200200 & 600600
- K021699 — AUTOLENS CLEANING AND DISINFECTING UNIT
- K022683 — SAS BLOOD/SERUM/URINE/URINE HCG
- K022762 — JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050
- K023027 — PREG-Q EARLY PREGNANCY TEST
- K023081 — PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)
- K023084 — MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
- K023087 — GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
- K023089 — GELSPHERES EMBOLIC AGENT
- K023101 — AMEDICA DRUG SCREEN METHAPHETAMINE TEST
- K023104 — AMEDICA DRUG SCREEN AMPHETAMINE TEST
- K023109 — AMEDICA DRUG SCREEN PHENCYCLIDINE TEST
- K023316 — SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
- K023361 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML)
- K023397 — ABBOTT ARCHITECT FOLATE
- K023405 — TROJAN MINT TINGLE BRAND LATEX CONDOMS
- K023489 — QUICKTOX MULTIPLE DRUG DIPCARD
- K020899 — PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
- K021643 — HA ORBITAL IMPLANT
- K022661 — A1CNOW FOR HOME USE
- K022732 — INFANT/CHILD REDUCED ENERGY ELECTRODES
- K022773 — BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM
- K022905 — LIFEJET F16 HEMODIALYSIS/APHERESIS CHRONIC CATHETER
- K023017 — TUCKER EMBRYO CATHETER
- K023063 — COMPREHENSIVE HUMERAL FRACTURE SYSTEM
- K023129 — UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK)
- K023175 — UNIDUS MALE LATEX CONDOM (WITH COLOR AND FLAVORING)
- K023176 — UNDUS MALE LATEX CONDOM (WITH FLAVORING)
- K023212 — AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS
- K023229 — S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE
- K023233 — EBI TARGETCATH FLUORO-GUIDED STEERABLE CATHETER SYSTEM
- K023243 — MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
- K023261 — ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244
- K023292 — APEX HRI DIGITAL RADIOGRAPHY SYSTEM
- K023383 — COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER
- K023384 — COOPERSURGICAL TRIAL TRANSFER CATHETER
- K023403 — SPERMGRAD, MODELS 10022/10063
- K023415 — MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM
- K023466 — TULIP ALGINATE IMPRESSION MATERIAL
- K023477 — BIOLOY
- K023491 — AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM
- K023500 — DIGITAL CLINICAL THERMOMETER, MODEL BABY TEMP/WL-3305 AND BABY TEMP (+) /WL-3306
- K023541 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML)
- K023655 — ENHANCE HTF MEDIUM WITH HEPES
- K023717 — SPERM WASH MEDIUM WITH GENTAMICIN
- K023788 — COLUMBUS (CR) TOTAL KNEE SYSTEM
- K023797 — LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
- K023827 — PARAGON INFUSION SYSTEM WITH BOLUS
- K023832 — SURESTEP HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
- K023853 — K-ASSAY LP(A) CONTROLS
- K023938 — MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325
- K013562 — AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE
- K021682 — OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC
- K021726 — GEBAUER'S INSTANT ICE
- K023051 — INTRAUTERINE DELIVERY SYSTEM - INJECTOR
- K023059 — UNIDUS MALE LATEX CONDOM
- K023147 — ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4
- K023180 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
- K023317 — METHADONE ENZYME IMMUNOASSAY
- K023328 — REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH
- K023770 — K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
- K023886 — ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D
- K023957 — SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES)
- K024030 — MILLENNIUM SERIES MANUAL WHEELCHAIRS
- K014152 — NXSTAGE CARTRIDGE EXPRESS
- K014277 — KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
- K021039 — BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
- K022888 — ACUBEAM, SUPER NOVA, DIO
- K022928 — HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS
- K023041 — W.O.M. LASER U100
- K023188 — PRESS-FIT HEAD RESURFACING DEVICE
- K023232 — SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE
- K023267 — T2 SUPRACONDYLAR NAIL SYSTEM
- K023299 — ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
- K023330 — BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
- K023379 — COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER
- K023395 — PORTADUR P2
- K023597 — ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY
- K023777 — ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183
- K023803 — MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
- K023880 — CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.