FDA 510(k) clearances — page 763
clearances on record, most recent first.
Clearances — page 763
76,201–76,300 of 175,825- K020911 — MID LABS AUTONOMOUS VIT ENHANCER (AVE)
- K021055 — BUSSE UMBILICAL CORD CLAMP CUTTER
- K021155 — MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
- K012214 — CRYOPEN AND ACCESSORIES
- K013234 — MICROJET CRONO
- K013776 — MICROJET MODEL # CD4 AND CD4/20
- K020272 — MALE LATEX CONDOM WITH RIBBED SURFACE
- K020307 — LAP DISC 120 X 120MM X 2CM #LD111; LAP DISC 120 X 120MM X 7CM #LD112
- K020392 — FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
- K020546 — FUSION 7D
- K020556 — MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN
- K020578 — GC FUJI ORTHO BAND PASTE PAK
- K020626 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
- K020690 — OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS
- K020705 — SIIS#1 TISSUE SUSPENSION SYSTEM
- K020901 — SERRALSILK
- K020989 — SUPER EON PLUS FEMORAL STEMS
- K021015 — ACIST PLUS 4 ANGIOGRAPHIC CATHETER
- K021123 — BACT/ALERT SN CULTURE BOTTLE
- K021197 — SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16
- K010128 — COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE
- K013310 — PVS BASIC 2; EPIC 2
- K013517 — 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600
- K014089 — VISUALINE II (ALSO KNOWN AS SUNLINE) BARITURATES
- K014168 — AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)
- K020268 — ISAAC 1.5 T MR SYSTEM
- K020333 — ATRION MEDICAL QL FLUID DISPENSING SYRINGE
- K020708 — PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES
- K021005 — SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE
- K021026 — S2 FEMORAL NAIL
- K021027 — S2 TIBIAL NAIL
- K003896 — LYMPHA VISION-EXPERT
- K020257 — DATASCOPE'S 8FR. ALT B IAB; DATASCOPE'S PROFILE 8FR. ALT B IAB; DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB; DATASCOPE'S
- K020289 — MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS
- K020347 — AGC SPEZIALLEGIERUNG
- K020515 — JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA
- K020532 — POLYMEDCO HBA1C TEST
- K020570 — SIMPLICITY
- K020601 — FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL
- K020954 — H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
- K021103 — MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM
- K012387 — STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
- K020230 — DIASOL-BICARB
- K020300 — NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)
- K020495 — INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL
- K020505 — SYNTHES TRANSLATING MAXILLARY DISTRACTOR
- K020604 — WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300
- K020838 — ULTRA TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K021051 — ANNULOFLO SYSTEM, MITRAL MODEL AR700
- K013865 — TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
- K013905 — MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
- K020184 — HOMMED CENTRAL STATION
- K020218 — SNAP EEG MONITOR
- K020244 — SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)
- K020294 — MOTION TRACKING
- K020397 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML)
- K020499 — BOND-3 ADHESIVE
- K020555 — SONATA MICRO HYBRID COMPOSITE
- K020589 — 3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
- K020610 — LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
- K020746 — BIRD TBIRD VELA VENTILATOR
- K020819 — DISTAL RADIUS PLATING SYSTEM
- K020868 — CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE)
- K021048 — THERMOMETER MODELS ST8631
- K013122 — EMS ELECTROSTATIC FLITER AND HME COMBINATION
- K014123 — BACTEC MGIT 960 SIRE KITS
- K020079 — BLADEWORKS MICROKERATOME BLADE, MODEL 7061
- K020112 — 50S TRINGA ULTRASOUND IMAGING SYSTEM
- K020303 — XR PRIMER 2
- K020390 — MODIFICATION TO FETAL ASSIST
- K020694 — QAB2A IGM ELISA KIT
- K020695 — QAB2A IGG ELISA KIT
- K020918 — ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE
- K020919 — ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1
- K021136 — TEKNIQUE-HOVEROUND POWER WHEEL CHAIR
- K021213 — MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
- K013281 — VERSALAB APM
- K020815 — BACT/ALERT FN CULTURE BOTTLE
- K020923 — BACT/ALERT PF CULTURE BOTTLE
- K020931 — BACT/ALERT SA CULTURE BOTTLE
- K011793 — KSEA FIBERSCOPE
- K011880 — COMPEX SPORT
- K013597 — TAMPONADE UTERINE BALLOON CATHETER SET
- K013882 — OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I
- K014274 — NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000
- K020242 — EMULATE FAST SET AND EMULATE REGULAR SET
- K020253 — 4 ALL (DW286A)
- K020292 — UTERINE INJECTOR
- K020319 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)
- K020387 — MYALLERGYTEST SYSTEM
- K020432 — PULPDENT GLAZE
- K020481 — PULPDENT POST CEMENT
- K020506 — MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML)
- K020813 — BACT/ALERT FA CULTURE BOTTLE
- K020858 — NXSTAGE THERAPY SYSTEM
- K020864 — EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900
- K020890 — SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
- K020940 — SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X
- K020947 — MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS
- K020955 — NICOLET ELECTROCAUTERY DETECTOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.