FDA 510(k) clearances — page 483
clearances on record, most recent first.
Clearances — page 483
48,201–48,300 of 175,770- K103707 — VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLE
- K103732 — SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
- K103785 — MOBILE MIM
- K103816 — COHESION BONE CEMENT
- K110104 — BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
- K110124 — FETAL DOPPLER JPD-100S
- K070049 — FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
- K101801 — MONICA AN24
- K101890 — BALL ABUTMENT SYSTEM
- K102053 — BUTLER CALCI-FLOR PROPHYLAXIS PASTE
- K102592 — SUTRAZORB
- K102652 — NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS
- K102838 — PATIENT EXAMINATION GLOVES
- K102892 — ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
- K103020 — ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT
- K103233 — MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
- K103309 — OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS
- K103561 — MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
- K110045 — INTERFUSE DA INVERTEBRAL BODY FUSION DEVICE
- K100927 — SURGIAID
- K100948 — HYPO CLENZ WOUND WASH MODEL 100 PPM
- K102742 — NASAL CEASE
- K102795 — SIGNATURE PLANNER; SIGNATURE GUIDES
- K102945 — PEDIACYN ATOPIC DERMATITIS HYDROGEL
- K102995 — TALON SPINAL SYSTEM
- K103011 — ULTICARE SAFETY INSULIN SYRINGE
- K103113 — VASCULAIRE COMPRESSION SYSTEM
- K103143 — ARSTASIS ONE LATCHWIRE ACCESS SYSTEM
- K103190 — PROFIL COMPOSITES (PROFIL, PROFIL FLOW)
- K103213 — FINESS ENDOSCOPE STERILIZATION TRAY
- K103347 — CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
- K103385 — SECURVIEW DX DIAGNOSTIC WORKSTATION
- K103387 — MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
- K103393 — POLARIS SPINAL SYSTEM
- K103506 — 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
- K103629 — PET-512MC TRANSESOPHAGEAL TRANSDUCER
- K110009 — ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
- K102238 — ARROW(R) NEXTSTEP TM ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
- K103056 — VISULAS TRION LASER SYSTEM WITH THE VITE OPTION
- K102369 — PICCOLO COMPOSITE NAILING SYSTEM
- K102924 — AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
- K103208 — REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM
- K103254 — PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE
- K103256 — SMITH & NEPHEW SMF HIP STEM
- K103288 — DEKA SYNCHRO FT
- K103465 — SYNAPSE 3D CARDIAC TOOLS
- K103677 — M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
- K110071 — COR ANALYZER
- K101016 — ANS SYSTEM
- K101136 — FISIO CHAMBER SPACE
- K101263 — LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,
- K101454 — MAMMAPRINT
- K102319 — COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-2008
- K102621 — SOLSTICE
- K102664 — HEMA SCREEN ER
- K102824 — AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC
- K102884 — STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR
- K103009 — SENTICARE PILLSTATION
- K103014 — MIRADRY SYSTEM
- K110077 — NEUCOLONCARE
- K092025 — FLUID FILLED TEETHER - GEL
- K093617 — VENTLAB 6000 SERIES HUMIDIFIER
- K101346 — GC ORAL MOISTURIZING GEL
- K101459 — OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770
- K102363 — SPSMEDICAL EMPLUS 270 F STEAM EMULATOR MODEL EMP-104, EMP-1004
- K102722 — NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
- K103297 — REDONDO-L
- K103782 — 4D MV-ASSESSMENT 2.0
- K101628 — KOWA NONMYD WX
- K101643 — MODEL LTV 1100 VENTILATOR
- K101807 — STAYHEALTHY BODY COMPOSITION MONITOR-BCM
- K101945 — NEODENT IMPLANT SYSTEM
- K102101 — SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA
- K102792 — DISPOSABLE BLOOD PRESSURE CUF
- K102886 — CD HORIZON SPINAL SYSTEM
- K102927 — CONSENSUS KNEE SYSTEM
- K103176 — FREQUENCER
- K103187 — TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM
- K103305 — PENUMBRA EMBOLIZATION COIL SYSTEM
- K103522 — SEDECAL
- K103778 — LEFORTE NEURO SYSTEM BONE PLATE
- K103780 — MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM; MICRUS ASCENT OCCLUSION BALLOON CATHETER 6X9 MM; MICRUS SUMMIT OCCLUSIO
- K103800 — BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED EAR THERMOMETERS
- K110004 — ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE
- K110040 — OMNIVISION
- K110048 — CERSR ELECTROMYOGRAPHY SYSTEM
- K110085 — VANTAGE VIEW SYSTEM
- K090145 — SURECALL EMG LABOR MONITOR
- K093989 — ORAL FLUID PHENCYCLIDINE
- K100794 — FLUORCANASITE DENTAL CERAMIC
- K100875 — CEROX, MODEL 321OF
- K101171 — ORTHOVITA PEEK SPACER
- K101225 — PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1
- K101741 — DIATRON PICTUS 400
- K102561 — ORTHODONTIC CERAMIC BRACKET
- K102713 — TIGER FLAT SURGICAL MASK
- K102853 — FLAMENCO SPINAL FIXATION SYSTEM
- K103166 — CHEETAH RELIANT
- K103271 — MSC LIPID CONTROL
- K103450 — FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.