FDA 510(k) clearances — page 804
clearances on record, most recent first.
Clearances — page 804
80,301–80,400 of 175,825- K010338 — ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
- K010339 — ENDOCARE PERCUTANEOUS ACCESS SET
- K010362 — ACCU-CHEK COMFORT CURVE TEST STRIP
- K002088 — SHAVER ABLATOR
- K002548 — FETAL ASSIST
- K002689 — SWABSITE SWABBABLE VALVE, MODEL 245000
- K003765 — LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
- K003777 — CARIS SITE MARKER
- K003864 — INJEX 50 SYSTEM
- K004045 — SUSCEPTIBILITY TEST PANEL
- K010381 — D.SIGN 30
- K010419 — MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
- K003590 — GRAMS POLYESTER NONABSORBABLE SUTURE
- K003784 — MENTOR SELF-CATH PLUS
- K010096 — MULTI CARE THERAPEUTIC VIBRATOR
- K010358 — VIGIL SEROLOGY CONTROL LEVEL C
- K000180 — TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
- K002095 — SNAP MODEL 6
- K002468 — SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050
- K002489 — INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM
- K004044 — HOMMED SENTRY III PATIENT MONITOR SYSTEM
- K010330 — ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
- K010453 — M2376A DEVICELINK SYSTEM
- K001708 — PROFOX SOFTWARE, MODEL 920M-41
- K003059 — LASER 4SPSC340
- K003328 — ACCUCLOT CONTROL I, MODEL A4089
- K003329 — SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
- K003362 — ASTRONOMER+WITH SLD
- K003411 — ELECSYS TESTOSTERONE CALSET II
- K003705 — XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
- K003715 — COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II
- K003717 — INSTRUMENTS FOR LAPAROSCOPY 5 MM, 10 MM WITH COLOURED HANDLE, DETACHABLE ENDODCOPIC INSTRUMENTS 5 MM, 10MM (HANDLE, SHAF
- K003725 — 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS
- K003808 — TAKE 1
- K003875 — TI-REPLICA HIP STEM
- K003886 — PALOMAR SPALIGHT PULSED LIGHT SYSTEM
- K003893 — VULCAN ABLATOR ELECTROSURGICAL PROBES, VULCAN LIGAMENT CHISEL ELECTROSURGICAL PROBES, MODEL 91000X,91002X,91300X
- K010146 — ENA EIA KIT RANGE
- K010147 — ENA EIA KIT
- K010188 — BD ECLIPSE HYPODERMIC NEEDLE
- K010285 — CONTOUR PROFILE LASER
- K010320 — MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
- K010329 — LOGIQ 500
- K010382 — 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
- K010511 — MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
- K002827 — MAC ACUPUNCTURE NEEDLE
- K003719 — VASCULAR ARCHITECTS PERISCOPE DEVICE
- K003762 — ALI 3D TOOL MODULE FOR MEDICAL IMAGES
- K003801 — ANATOMICAL PRESS-FIT HUMERAL STEM
- K003865 — COBAS INTEGRA AMPHETAMINES
- K003963 — DIMENSION PSA FLEX REAGENT CARTRIDGE
- K010077 — HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES
- K010109 — FLUOROPERM 151-OK, PARAGON HDS 100-OK
- K010111 — CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK
- K010250 — TETRIC CERAM HB
- K010257 — ZOLL M SERIES
- K010261 — CARDIOMEDICS ECP SYSTEM
- K010349 — DUAL LUMEN MIDLINE CATHETER
- K010444 — ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP
- K001744 — OLYMPUS ENDOSCOPIC LIGATION DEVICE
- K002666 — DIAMOND ALOE VERA, STERILE
- K003102 — PARE ENDOSCOPIC SUTURING SYSTEM
- K003699 — MEDIVISION IGS SYSTEM
- K003786 — SMF RESORBABLE MESHES AND SHEETS
- K003868 — SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
- K003946 — SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL
- K010059 — ENGPLUS
- K010267 — PALFIQUE ESTELITE LV CLEAR
- K010386 — DUO-DENT DENTAL IMPLANT
- K010502 — MODEL THERMO TEK QUICKCARE
- K000581 — MAEDA NEW NEEDLE DISPOSABLE
- K002756 — EASE-A-CULT
- K003347 — ORTHOPILOT
- K003648 — FREEDLAND TENSION SYSTEM
- K003649 — TRITON HIP SYSTEM
- K003665 — FADASSI MEDICAL FM-1 NO BLENDER
- K003684 — PERCUSSIVENEB, MODEL PN-2001
- K003749 — 100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN
- K003776 — MICROTARGETING DRIVE SYSTEM
- K003834 — SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
- K010021 — MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S
- K010148 — ENA SCREEN EIA KIT
- K010198 — STERILE POWDERED LATEX SURGEON GLOVES
- K010249 — CD HORIZON SPINAL SYSTEM
- K001631 — CORTEX METAMAX
- K002079 — MULTI-FUNCTION DEFIBRILLATION ELECTRODE
- K002515 — MEDLOGICS ML 4000, MODEL 4000
- K002758 — AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A
- K003260 — VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
- K003268 — Z-TOUCH
- K003423 — ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055
- K003629 — MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03
- K003640 — MINIENDO III
- K003646 — SUTUREGROOVE WEIGHT SIZING SET
- K003672 — MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE
- K003703 — TAUT-INSUFFLATION NEEDLE
- K003806 — URETEROSCOPES
- K003807 — CYSTOSCOPES
- K003885 — VISULAS YAG II
- K003914 — MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.