FDA 510(k) clearances — page 639
clearances on record, most recent first.
Clearances — page 639
63,801–63,900 of 175,825- K052522 — STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2
- K052573 — STARDUST II
- K052635 — TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
- K052701 — COROLENE
- K052776 — TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD
- K052866 — OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER
- K053063 — PRO-FLOW MULTIPURPOSE CANNULA
- K053149 — SPIRO-BALL
- K053282 — ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP
- K053365 — MODIFICATION TO THERMAGE THERMACOOL SYSTEM
- K050817 — T-TEK
- K050921 — EASYSTIM NMS-28
- K051926 — LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
- K052133 — IMMUNOSCAN RA ANTI-CCP TEST SYSTEM
- K052210 — NUVASIVE COROENT EXTENSURE SYSTEM
- K052688 — ELLIPSE FLEX PPT, MODEL 9ESF7255
- K052847 — CAPLESS PEDICLE SCREW SYSTEM
- K052901 — ARTHREX TENSIONLOK
- K053261 — ORTHOFIX TITANIUM NAILING SYSTEMS
- K050933 — FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300
- K051275 — LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM
- K051373 — CRONUS GUIDEWIRE, MODEL 001-001470-1
- K051520 — GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
- K051691 — MINIMATE COMPRESSOR
- K052177 — POWDER FREE STERILE LATEX SURGICAL GLOVES
- K052208 — GLUCOSE PILOT
- K052340 — DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM
- K052396 — OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
- K052539 — COOK FORMULA 418 BILIARY STENT SYSTEM
- K052586 — A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P
- K052615 — MEDISIZE GOLD
- K052622 — MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
- K052781 — BREFORMANCE
- K052804 — BREATHKEY MODEL G10/BREATHKEY MODEL G30X
- K052941 — I-NEB INSIGHT AAD SYSTEM
- K053120 — STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES
- K053157 — AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
- K053162 — DEXTROSCOPE & DEXTROBEAM
- K053189 — COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES
- K053201 — CURAE'LASE CL1000 IR LASER SYSTEM
- K053258 — EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
- K053346 — MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900
- K053349 — HOFFMANN II ROD TO WIRE COUPLING
- K051300 — ROBIN HOOD VEST
- K052023 — CADIMAS VERSION 1.0
- K052221 — AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP
- K052428 — RESOLUTION ENDOVASCULAR SYSTEM
- K052451 — MPS ACACIA MEDFLO ELASTOMERIC PUMP
- K052490 — ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K052841 — MIRA-FLEX 18 MICROCATHETER
- K052887 — SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD), MODEL SV-S23BL35VS
- K052946 — MPS ACACIA NERVE BLOCK NEEDLE
- K053129 — NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5
- K053167 — BIOPURE MTAD ROOT CANAL CLEANSER
- K053175 — AMEDITECH DRUGSMARTCUP
- K051513 — BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
- K051693 — MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
- K051714 — TOTAL BILE ACIDS ASSAY, MODEL DZ042A
- K051733 — ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
- K052108 — SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
- K052151 — SYNTHES PANGEA MONOAXIAL SYSTEM
- K052249 — UTOPIA
- K052275 — SMITH & NEPHEW PLATFORM HIP STEM
- K052343 — E-SAN BLUETOOTH CRADLE
- K052398 — MESA SPINAL SYSTEM
- K052426 — SMITH & NEPHEW MODULAR HIP
- K053031 — EXTENDSURE HBFASC CONTROL
- K053093 — KALIX II IMPLANT, MODEL 141 0XX WITH XX
- K053119 — DISTAL RADIO-ULNAR JOINT IMPLANT
- K053160 — MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE
- K053200 — GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
- K053202 — GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
- K053281 — EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)
- K053325 — MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001
- K050526 — POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR
- K051101 — VERIFY FLASH INTEGRATOR
- K051371 — INTERBODY INNOVATIONS CEMENT RESTRICTOR
- K051638 — INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
- K051911 — GELITA-SPON
- K052560 — BIOFINITY (COMFILCON A) SOFT CONTACT LENS
- K052738 — INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044
- K052888 — POROUS TITANIUM ACETABULAR AUGMENTS
- K052962 — OPTIMIZED BARB DESIGN
- K053115 — XIA SPINAL SYSTEM
- K053297 — ARTHROCARE 8000S COBLATOR SURGERY SYSTEM
- K043209 — VIAGRAF DBM PASTE
- K050150 — MANI NEEDLE & SUTURE PACK
- K050642 — ORTHOBLAST II PUTTY AND PASTE
- K050726 — SILVERSEAL SILVERAID WITH X-STATIC
- K051324 — MEDI BUTLER
- K051382 — ELECSYS PROBNP IMMUNOASSAY
- K051484 — ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
- K052026 — LINEAGE A-CLASS POLY LINER
- K052445 — DUOPROSS NEEDLE
- K052572 — ANSPACH KNOTLESS ANCHOR
- K052625 — BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
- K052644 — SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
- K052683 — SYNTHES (USA) STERNAL FIXATION SYSTEM
- K052728 — POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES
- K052963 — MEDIQ VERSION 1.0
Data sourced from openFDA. This site is unofficial and independent of the FDA.