FDA 510(k) clearances — page 694
clearances on record, most recent first.
Clearances — page 694
69,301–69,400 of 175,825- K031601 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)
- K031982 — BIRDSONG LEVERHALER, MODEL LH-1000
- K032951 — CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
- K033864 — GENZYME OSOM TRICHOMONAS RAPID TEST
- K033875 — ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
- K033888 — MSI MODEL S-500 RF GENERATOR
- K040012 — WELL@HOME SYSTEM
- K040197 — EAGLE ANTERIOR CERVIAL PLATE SYSTEM
- K040234 — LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM
- K040264 — CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
- K040352 — NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)
- K040375 — IDEAL 1 ORTHODONTIC BAND CEMENT
- K040566 — RESMED HOSPITAL NASAL MASK
- K040665 — SOMATOM SENSATION 64 AND SENSATION CARDIAC
- K040711 — MESACUP TEST PR-3
- K040718 — TRUST
- K040742 — MODIFICATION TO STERRAD SEALSURE CHEMICAL INDICATOR TAPE
- K040797 — BRITESMILE MASKING CREAM
- K024186 — X-VIEW
- K030784 — NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL
- K030989 — OSTEOSORB TACK FIXATION SYSTEM
- K032406 — STRYKER RF ELECTRODES AND CANNULAE
- K032534 — SYNTHES AFS
- K032601 — STRYKER INTERVENTIONAL PAIN RF GENERATOR
- K033072 — LUCENTLITE, MODEL IMD 010
- K033337 — ULTRAPRO MESH
- K033801 — KYPHX HV-R, MODEL C01A
- K040042 — MEDISIL SILICONE SHEETING
- K040081 — PALOMAR LUXV HANDPIECE
- K040087 — RABBIT
- K040144 — QUIXX POSTERIOR RESTORATIVE
- K040240 — STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
- K040369 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
- K040543 — NUVASIVE NEUROVISION JJB SYSTEM
- K040553 — MODIFICATION TO ACCULEAF
- K040633 — CLICK-ON
- K032717 — BIOCRYL RAPIDE INTERFERENCE SCREW
- K033074 — INION GTR BIODEGRADABLE MEMBRANE SYSTEM
- K033645 — OTOFLEX 100 TYE 1012
- K033702 — BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
- K033901 — MERLIN SPINE SYSTEM
- K033979 — CORLINK AUTOMATED ANASTOMOTIC SYSTEM
- K040080 — AESCULAP ABSORBABLE CRANIOFIX
- K040083 — SYNTHES EXTERNAL MIDFACE DISTRACTOR
- K040297 — ONEUSE- PLUS MICROKERATOME
- K040561 — MANUAL WHEELCHAIR SERIES
- K040583 — MODIFICATION TO: CD HORIZON SPINAL SYSTEM
- K040594 — HERCULON SOFT TISSUE REATTACHMENT SYSTEM
- K040596 — ULTRASOUND IMAGING SYSTEM, MODEL 7300
- K032143 — LIQUID OXYGEN SYSTEM
- K034011 — GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
- K040027 — BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
- K040635 — CARRARA INTERACTION CERAMIC SYSTEM
- K032227 — DUREX FLAVORED LATEX CONDOM
- K032445 — THE ULTRA SYSTEM
- K033986 — MLT-1000 IR LASER SYSTEM
- K040005 — PROFILE 2000/3000 LASER SYSTEM
- K040040 — NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM
- K040041 — NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM
- K040065 — JSA'S REPROCESSED COMPRESSION SLEEVE DEVICES
- K040399 — QONTRAST
- K040535 — LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS
- K023525 — RETISCAN, RETIPORT
- K031421 — ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
- K032386 — UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)
- K032730 — FIXION HIP SYSTEM
- K032816 — QUANTUM LIGHT THERAPY SYSTEM
- K033050 — EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2
- K033090 — ICON POLYAXIAL PEDICLE SCREW SYSTEM
- K033236 — PRIZM KERATOME BLADE, MODEL MK8512M2
- K033460 — CHEETAH WHEELCHAIR
- K033970 — CLEARFIL PHOTO CORE PLT
- K034025 — NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
- K034068 — CONTOUR SE MICROSPHERES
- K040003 — VERTEBRON SCP CERVICAL PLATE SYSTEM
- K040128 — MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
- K040130 — ANTERIOR LUMBAR BUTTRESS SYSTEM
- K040216 — CERASORB M ORTHO
- K040527 — LOW PROFILE LUTHER SAFETY HUBER
- K040719 — ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY
- K031176 — INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
- K033994 — NOVABONE-BBG-RESORBABLE BONE GRAFT SUBSTITUTE
- K040053 — PRECISION VPS IMPRESSION MATERIAL
- K040109 — HEMORRHAGE OCCLUDER PIN
- K040203 — MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22
- K040226 — WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
- K040517 — TENDERWET ACTIVE
- K040568 — POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS
- K040609 — RAPID PROGRAMMER
- K040618 — LED TURBO
- K040628 — PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
- K040670 — MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL
- K040694 — MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
- K032657 — TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)
- K033173 — MICRO TARGETING ELECTRODE
- K033644 — ENDOBOY
- K034035 — 3I PATIENT-SPECIFIC OVERDENTURE BAR
- K040050 — INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
- K040051 — MEGVISION, MODEL EQ1000C SERIES
- K040110 — EASY LOOP, MODEL EZL-01
Data sourced from openFDA. This site is unofficial and independent of the FDA.