FDA 510(k) clearances — page 486
clearances on record, most recent first.
Clearances — page 486
48,501–48,600 of 176,542- K110660 — ARTHREX BIOCOMPOSITE SUTURETAK
- K110796 — SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE
- K102115 — ODFS PACE
- K102402 — SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM
- K102936 — HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R
- K103106 — CHLORASHIELD TM ANTIMICROBIAL DRESSING
- K103410 — NEOPAP SYSTEM
- K103586 — IOS FASTSCAN SPRAY
- K110038 — TRUCLEAR MORCELLATOR SYSTEM
- K110721 — GAUNYING INFRARED LAMP
- K101530 — EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D
- K103026 — ELECTRO SENSOR -BODY COMPOSITION
- K103038 — DUET DRF
- K103425 — ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM
- K103591 — DIGITAL RADIOGRAPHY
- K103596 — WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR
- K103828 — BILI-THERAPY SPOT TYPE
- K110591 — MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL
- K110685 — FLEXIVA TRACTIP
- K093987 — IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
- K101154 — CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-L
- K102521 — PANTINO PRO POSITINER
- K102874 — NEW STETIC ACRYLICS
- K110036 — FX 222-02 POWERED WHEELCHAIR
- K110050 — FIT TEST C&B
- K110686 — ACCUTRAC
- K101560 — MEDLINE RETRACTABLE SAFETY SYRINGE
- K101971 — SYNTEC OS SPINAL FIXATION SYSTEM
- K102196 — COMPUTED TOMOGRAPHY X-RAY SYSTEM
- K102275 — THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240
- K102578 — APEX PS KNEE SYSTEM
- K102640 — VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS
- K103105 — ORTHODONTIC SCREW
- K103237 — LANX SPINAL SYSTEM
- K103389 — TRUCLEAR INCISOR PLUS BLADE 2.9
- K103551 — INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,
- K110385 — ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
- K110526 — ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
- K110585 — CAPTIVA SPINE FUSELOX CERVICAL CAGE
- K110699 — LIGAMAX 5
- K094035 — EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
- K101721 — WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
- K102465 — BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
- K102647 — ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...
- K102677 — BODYTOM NL 4000
- K103170 — GMK REVISION KNEE SC LINERS
- K103395 — PERFORMAX TOTAL FACE MASK
- K103427 — MOBILEECG SYSTEM
- K103656 — THERMO SCIENTIFIC MAS R DOA TOTAL
- K103786 — ZEST PETITE NASAL MASK
- K103837 — BALANCED KNEE SYSTEM REVISION OFFSET TIBIA
- K110042 — MANUKATEX
- K110054 — NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE
- K110332 — CLEARCANVAS RIS / PACS
- K110416 — ABL835 FLEX ANALYZER WITH PLEURAL PH
- K110555 — ARCOMXL ACTIVE ARTICULATION
- K101644 — QUANTA FLASH H-TTG IGG
- K101852 — CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT
- K101920 — VENTRIO ST HERNIA PATCH
- K101928 — VENTRALEX ST HERNIA PATCH
- K102241 — ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT
- K103111 — FORZA SPACER SYSTEM
- K103245 — CELSTAT
- K103650 — NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM
- K103661 — RUBBERCARE POWDER FREE NITRILE EXAMINATION GLOVE
- K103666 — LANX LATERAL
- K110367 — PIONEER SPINAL PROCESS FUSION PLATE
- K110512 — SIMMETRY SACROILIAC JOINT FUSION SYSTEM
- K110552 — VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW
- K092138 — JTS EXTENDEABLE IMPLANT
- K093046 — ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES
- K101422 — THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
- K101887 — CONFIDENT SURGERY SUITE 300, MODEL CSS300
- K102533 — ROTATING GAMMA SYSTEM INFINI (INFINI)
- K102635 — APOLONIA LASER IMPLANT SYSTEM
- K103411 — IDEAL IQ SOFTWARE OPTION
- K103567 — LIFEPAK 15 MONITOR/DEFIBRILLATOR
- K103640 — MIDMARK IQECG
- K103696 — ERBEFLO CLEVERCAP HYBRID TUBING/CAP SETS FOR OLYMPUS MODELS 160 AND 180 SERIES SCOPES
- K103711 — ORTHOPHOS XG 3D / CEPH
- K103751 — MUSTANG BALLOON DILATATION CATHETERS
- K103813 — SOPRO 281
- K110151 — ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
- K100424 — DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS
- K103721 — MPACT ACETABULAR SYSTEM
- K110299 — DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES
- K110501 — HEM-4030
- K101792 — LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706
- K101916 — JOULE MULTI-PLATFORM SYSTEM
- K102299 — CPR FACE MASK
- K102586 — S9 VPAP ADAPT WITH H5I
- K102588 — ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE
- K102779 — EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C
- K102958 — PHILIPS AVALON FETAL MONITOR
- K103136 — SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
- K103579 — INTRA SKAN DC
- K103705 — LOW PROFILE SCREWS
- K103798 — BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
- K110064 — SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
- K110224 — SYNTHETIC VINYL EXAMINATION GLOVE, POWDER FREE
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