FDA 510(k) clearances — page 435
clearances on record, most recent first.
Clearances — page 435
43,401–43,500 of 175,770- K122329 — BIOJET
- K112548 — ALTOMEC ARTHROSCOPE
- K120902 — GID 700
- K121352 — ARMADA 14XXT PTA CATHETER
- K121615 — 4CIS VANE SPINE SYSTEM
- K121727 — MOVATION KNEE SYSTEM
- K122036 — VISI MOBILE MONITORING SYSTEM
- K122070 — CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
- K122205 — EXINI
- K112362 — C100 WRINKLE REDUCTION DEVICE
- K113045 — BIOHARNESS
- K120158 — CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
- K120320 — CONNECTED CARE CLINICAL APPLICATION
- K120789 — EXACTRAC X-RAY X-RAY
- K121334 — VARIOECO
- K121396 — DYNAFLEX
- K121776 — AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
- K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
- K122265 — VIALOK SINGLE VIAL ACCESS DEVICE VENTED
- K122285 — TABLET COMMANDER
- K120152 — CERASORB PLUS
- K120446 — FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
- K120469 — ERISMA-LP
- K121443 — JOURNEY II CR KNEE SYSTEM
- K121667 — NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
- K121819 — SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
- K122246 — MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
- K111246 — SPIRALE DRUG DELIVERY SYSTEM
- K112534 — LIFECELL TISSUE EXPANDER
- K113210 — ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
- K113338 — MEDICAL AIR COMPRESSOR
- K113389 — ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
- K113607 — BIOPSY DIGIT S BIOPSY SL
- K113685 — POWDER FREE LATEX EXAMINATION GLOVES
- K120278 — WIRELESS IMAGE TRANSMITTER UNIT
- K120554 — ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
- K120715 — ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
- K120847 — ET/SS IMPLANT SYSTEM
- K121197 — BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
- K121320 — C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE
- K121368 — NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)
- K121390 — LUBE JELLY SURINGE
- K121429 — AIMAGO EASYLDI MICROCIRCULATION CAMERA
- K121513 — MULTIX FUSION
- K121632 — COMFORT EZ
- K121785 — SCEPTER C OCCLUSION BALLOON CATHETER
- K121997 — IMRIS ONCOLOGY PACKAGE
- K113692 — XENX
- K120553 — ESPIN
- K120714 — PICASSO MIS SPINAL FIXATION SYSTEM
- K120781 — CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
- K121136 — RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
- K121142 — CRAWFORD BIOCANALICULUS INTUBATION
- K121221 — PROFEMUR Z REVISION HIP STEM
- K121524 — INSIGNIA
- K112162 — CONICAL CONNECTION IMPLANTS
- K112787 — KERATOR
- K113507 — KENT CAMERA
- K113776 — FLASHPAK
- K113820 — NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER
- K120585 — CONVEY GUIDING CATHETER
- K121102 — OSTEOSYMBIONICS PEEK CRANIAL IMPLANT
- K121168 — APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
- K121172 — REFORM PEDICLE SCREW SYSTEM
- K121839 — UNBALLOON NON-OCCLUSIVE MODELING CATHETER
- K111953 — NAUTILUS SPINAL SYSTEM
- K113783 — VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE
- K113795 — SUCTION LIPOLASTY ACCESSORIES
- K120994 — BD BACTEC Plus PRIME Aerobic/F Culture Vials
- K121059 — SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM
- K121393 — SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION
- K122141 — IDS-ISYS IGF-I CALIBRATION VERIFIERS
- K112532 — ET II BIO-SA FIXTURE SYSTEM
- K113437 — ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT
- K120536 — HEART SYNC PEDIATRIC PHYSIO AED PAD
- K121158 — REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
- K121698 — NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN
- K122006 — G-SCAN BRIO
- K112692 — IDENTIFY
- K113077 — BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM
- K113536 — MASTERKA 40 MASTERKA 35 MASTERKA 30
- K113673 — MYSAFETY SYRINGE
- K120423 — BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650
- K120451 — 8MP COLOR LCD MONITOR, REDIFORCE RX840
- K120898 — KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
- K120961 — TREVO RETRIEVER
- K121048 — ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
- K121192 — NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)
- K121289 — LTM-LABAROSCOPIC SURGICAL MESH
- K121337 — UROPLASTY RIGID ENDOSCPIC NEEDLES
- K121526 — POWER-FREE NITRILE PATIENT EXAMINATION GLOVES
- K121789 — SHANGRING
- K121990 — PICC CONVENIENCE KIT
- K121996 — BE PLUS LTM AMPLIFIER GWI AMPLIFIER
- K122118 — HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
- K111534 — ABACUS 3CP
- K112620 — DISITAL BLOOD PRESSURE MONITOR
- K112864 — SOFTSEAL-C
- K120430 — MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P
- K120734 — MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE
Data sourced from openFDA. This site is unofficial and independent of the FDA.