FDA 510(k) clearances — page 631
clearances on record, most recent first.
Clearances — page 631
63,001–63,100 of 175,825- K060322 — CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED
- K060408 — NORIAN SRS BONE VOID FILLER
- K060417 — MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
- K052844 — KAVS - CATHETER, MODELS 1107100 & 1107060
- K053047 — FRAXEL SR LASER SYSTEM
- K053510 — IR WIRELESS FOOT SWITCH
- K060156 — STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM
- K060406 — NORIAN SRS FAST SET PUTTY
- K060455 — MULTISTAR
- K060457 — QUADROSTAR 532
- K060459 — QUADROSTAR 980
- K060468 — VECTORVISION HIP
- K043593 — SPINE-FIX BIOMIMETIC BONE CEMENT
- K051093 — OSTEOPORE PCL SCAFFOLD
- K051542 — TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING
- K051684 — EYEPORT VISION TRAINING SYSTEM
- K052785 — OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406
- K053345 — PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
- K053587 — ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS
- K060173 — ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS
- K060218 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML
- K060267 — VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE
- K060286 — TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K060424 — PANORAMIC, MODEL 200MA
- K060475 — EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8
- K060514 — STRYKER PLATING SYSTEM
- K060531 — QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS
- K060631 — BIOGRAPH 64 AND BIOGRAPH 40
- K050239 — EMD THERMOGRAPHY SYSTEM
- K051675 — BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER
- K052140 — SPIROLAB, SPIROLAB II
- K052598 — IMMOCARE
- K052777 — LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D
- K053074 — N ANTISERA TO HUMAN CERULOPLASMIN
- K053075 — N ANTISERA TO HUMAN TRANSFERRIN
- K053339 — ALLOFIX ANCHOR
- K053431 — ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM
- K053477 — MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS
- K053495 — EQUIPMENT SLUSH DRAPE
- K053536 — DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
- K053560 — MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE
- K053607 — BREAS VIVO 40 SYSTEM
- K060110 — CELLTRACKS ANALYZER II
- K060125 — SONIC PALPOMETER
- K060127 — HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
- K060132 — SPINAL USA CEMENT RESTRICTOR SYSTEM
- K060137 — KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
- K060216 — ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
- K060285 — BONEGEN - TR
- K060440 — CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER
- K060484 — ERBE VIO ESU, MODEL VIO 300 D
- K060582 — INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR
- K060637 — DENFIL FLOW
- K052310 — CRYOFLOW 700, CRYOFLOW 1000
- K052555 — MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB
- K053290 — COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES
- K053434 — MYOTRAC INFINITI ELECTRICAL STIMULATOR
- K053498 — HYPEROX 101
- K053507 — ELITE ELECTROMED L.I.T.E. 4/1
- K053611 — SMOOTHSHAPES
- K053622 — SURGISIS OCULAR GRAFT
- K060102 — SYNERGEYES PS HYBRID CONTACT LENS
- K060104 — PRISMATIK CLINICAL ZIRCONIA
- K060226 — ONCOR EXPRESSION
- K060229 — POWDER-FREE BLACK LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTE
- K060234 — MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
- K060263 — IQPACS
- K060328 — PLANMECA PROMAX 3D
- K060360 — HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS
- K060401 — MEDRAD 3.0T ECOIL IMAGING SYSTEM
- K060418 — 8F SHERPA NX GUIDE CATHETER
- K060429 — TDM CONTROL SET
- K060572 — MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
- K053255 — NEXUS LIGATING CLIP
- K053355 — BTI INTERNA DENTAL IMPLANT SYSTEM
- K053616 — POLARIS WR, ST APPLICATOR
- K053636 — MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)
- K060076 — SURGICOUNT SAFETY-SPONGE SYSTEM
- K060368 — INSPIRSTAR IS02 MICROCURRENT STIMULATOR
- K060504 — IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001
- K051596 — STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204
- K051875 — BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS
- K052567 — ONE TRAY SEALED STERILIZATION CONTAINER
- K053211 — RDI HSFERRITIN KIT
- K053268 — PVS 2000 SYNCHRO2 GUIDEWIRE
- K053291 — FERRITIN CALIBRATOR SET, CATALOG NO. 8203
- K053653 — FIDIS CONNECTIVE 10, MODEL MX006
- K060148 — EBI VERTEBROPLASTY SYSTEMS
- K060373 — COBAS 6000 SERIES SYSTEM
- K060393 — INION HEXALON BIODEGRADABLE ACL/PCL SCREW
- K060419 — CONCERTO BIPOLAR NEEDLE ELECTRODE
- K060491 — QUANTUM ANTERIOR CERVICAL PLATE SYSTEM
- K060534 — INTUITIVE SURGICAL SEAL
- K051128 — ELECTROPULSE
- K051477 — MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC)
- K052212 — MIGUE
- K052839 — CT PERFUSION 4
- K053102 — BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE
- K053284 — MAGBODY DT-600
- K053335 — PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
Data sourced from openFDA. This site is unofficial and independent of the FDA.