FDA 510(k) clearances — page 391
clearances on record, most recent first.
Clearances — page 391
39,001–39,100 of 175,770- K133726 — MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE
- K133728 — DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
- K133881 — MACY CATHETER
- K133987 — CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
- K140058 — ATRICURE CRYO MODULE SYSTEM
- K130666 — KHAN KINETIC TREATMENT (KKT-M2)
- K131490 — ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
- K131580 — AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8
- K132725 — JUVORA DENTQAL DISC
- K132841 — ZYNO MEDICAL ADMINISTRATION SET
- K132928 — MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE
- K132989 — SPEED 808 DIODE LASER SYSTEM
- K133037 — GRINDGUARD
- K133100 — CAREFINE PEN NEEDLE
- K133622 — MAC 2000 ECG ANALYSIS SYSTEM
- K133675 — AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5
- K130613 — CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM
- K131135 — BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
- K131644 — ANKYLOS SYNCONE ABUTMENT 5(DEGREE)
- K131837 — CO2 FRACTIONAL LASER
- K132122 — KESTREL POSTERIOR CERVICAL SPINE SYSTEM
- K132286 — HYPERION LONG PULSED ND: YAG LASER
- K132421 — AESCULAP PEEK XP SPINAL IMPLANT SYSTEM
- K132609 — EDS ULTRASONIC TIPS
- K132722 — HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
- K132879 — MPACT EXTENSION
- K133030 — DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)
- K133152 — JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
- K133301 — ZOE FLUID STATUS MONITOR
- K133414 — REPROCESSED CLOSURE SYSTEM
- K133907 — VSP SYSTEM
- K133938 — ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY
- K133950 — ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)
- K133960 — LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
- K132125 — A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM
- K132499 — ICRCO CLARITY VIEWER
- K132764 — MOTION WATCH AND PRO-DIARY
- DEN130018 — CYTOSCAN(R) DX
- K123517 — GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM
- K130614 — BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS
- K131168 — IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
- K131245 — OREGON SCINTIFIC
- K131623 — SMARTDOP XT
- K132065 — INJECTION NEEDLE
- K132410 — DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W
- K132668 — IOB DISPOSABLE SPECULUM
- K132682 — PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA
- K132890 — SUPRAPUBIC CATHETER AND INTRODUCER SET
- K132921 — GALAXY PLUS
- K132931 — APOLLO SYSTEM
- K133197 — FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE
- K133228 — ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM
- K133277 — XARIO 100
- K133375 — BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR
- K133424 — SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16
- K133464 — MODIFIED TREVO PROVUE RETRIEVER
- K133833 — NUVIS DIAGNOSTIC ULTRASOUND SYSTEM
- K133869 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT
- K133875 — THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA
- K130732 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K130945 — CALPREST
- K131151 — ENDOCENTER
- K131799 — QUICKNIT
- K131857 — Q-SWITCHED ND:YAG LASER
- K132363 — DOLPHIX EXTERNAL FIXATION SYSTEM
- K132528 — E-PICCO CONTINUOUS CARDIAC OUTPUT MODULE AND ACCESSORIES
- K132894 — OPTIO-C ANTERIOR CERVICAL SYSTEM
- K133164 — DYNESYS TOP-LOADING SPINAL SYSTEM
- K133250 — STARLIGHT
- K133379 — HEM-7311
- K133698 — SYNAPSE SYSTEM
- K133727 — Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM, FIRSTPASS SUTU
- K133856 — POWERGLIDE MIDLINE CATHETER
- K131110 — ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD
- K131113 — BIOPHOTAS CELLUMA
- K131864 — U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT
- K132844 — STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES
- K133106 — COMPUTED RADIOGRAPHY SCANNER
- K133120 — COMPUTED RADIOGRAPHY SCANNER
- K133473 — ILUMINAGE SKIN SMOOTHING LASER
- K123758 — TASMIN R
- K130036 — COSENSE CO MONITOR
- K130692 — M2 WRIST 2 MRI SYSTEM
- K130735 — SYNTHETIC ABSORBABLE SUTURE
- K130737 — SYNTHETIC ABSORBABLE SUTURE
- K132739 — IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL
- K132984 — SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
- K133369 — TIGER SPINE SYSTEM
- K133499 — SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA
- K130552 — CT PULMONARY ANALYSIS
- K130674 — ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE
- K130828 — K SERIES CPAP SYSTEMS
- K131410 — CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),
- K132606 — S9 CRONULLA FOR HER
- K132641 — MODIFIED TREVO PROVUE RETRIEVER
- K132669 — PROXIFAST ABSORBABLE STAPLE
- K133021 — MIXING SYRINGE SYSTEM
- K133063 — SANTIS PEDICLE SCREW SYSTEM
- K133066 — SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM
- K133407 — GEM PREMIER 4000
Data sourced from openFDA. This site is unofficial and independent of the FDA.