FDA 510(k) clearances — page 660
clearances on record, most recent first.
Clearances — page 660
65,901–66,000 of 176,637- K050951 — MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370
- K051012 — PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.
- K051026 — MARS HOLTER ANALYSIS WORKSTATION
- K051162 — GENEROS SB SMALL BONE DISTRACTION IMPLANT
- K051216 — HYDRALOK SYSTEM
- K051329 — STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)
- K051571 — SKYLIGHT LED CURING LIGHT
- K051599 — NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
- K051623 — ANATOMICAL SHOULDER KEELED GLENOID
- K051634 — DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION
- K051682 — EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
- K051695 — MARROW PLUS (M+)
- K051710 — THERMAGE THERMACOOL COUPLING FLUID
- K051724 — ACUMEN IMAGE GUIDED SURGICAL SYSTEM
- K051735 — PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY
- K051737 — MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
- K051738 — SECUR-FIT MAX AND PLUS MAX HIP STEMS
- K050739 — CODMAN VPV SYSTEM, MODEL 82-3192
- K051316 — X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
- K051430 — EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC)
- K051497 — VITESSE 2.0
- K051545 — L.E. DEMETRON II
- K051673 — XELERIS 2 PROCESSING AND REVIEW WORKSTATION
- K043406 — VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
- K050260 — BIORESORB MACRO PORE
- K050785 — AMSINO ENDOTRACHEAL TUBE
- K050991 — THE ODFS DROPPED FOOT STIMULATOR
- K051062 — VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO
- K051253 — MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
- K051314 — RES TRAXX DATA CENTER
- K051381 — ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE
- K051424 — HYDROGUM 5
- K051439 — LNOP BLUE OXIMETRY SENSOR
- K051635 — DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES
- K051707 — ECLIPSE BONDING AGENT
- K051723 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW)
- K051833 — TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER
- K050410 — HES ULTRASONIC THERAPY APPLIANCE, MODELS HS-3008 (1MHZ), HS3026 (2MHZ), HS-3040 (3MHZ)
- K050620 — READMYHEART, MODEL RMH3.0
- K050848 — TORNIER ELBOW PROSTHESIS
- K050992 — CONMED IRRIGATION NOZZLE
- K051403 — 19-INCH (48CM) COLOR LCD MONITOR CDL1904A
- K051446 — FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS
- K051547 — POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30
- K051625 — BARRIER SURGICAL DRAPES
- K051679 — ILAB ULTRASOUND IMAGING SYSTEM
- K051686 — CARDIOMEM CM 3000-12
- K051692 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML
- K051745 — ECHOSYSTEM
- K051763 — QD KNEE/FOOT COIL, MODEL MJQJ-147A
- K051765 — CERETOM, MODEL NL3000
- K051795 — NOMAD DENTAL X-RAY SYSTEM
- K050135 — K-C HEMOSTATIC BIOPSY SYSTEM
- K050224 — 3TEST GLUCOSE MONITORING SYSTEM
- K050381 — CS MEDICAL TTCF GAS DELIVERY SYSTEM
- K050395 — IMPEDIMED - BODY COMPOSITION ANALYSIS
- K050797 — TISSU-TRANS
- K051049 — SYNTHES (USA) LOW-PROFILE WRIST FIXATOR
- K051142 — ANGIODYNAMICS TUMESCENT INFUSION DEVICE
- K051146 — TRIATHLON KNEE SYSTEM
- K051359 — CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY
- K051549 — CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM
- K051659 — SEMIAL SPINAL IMPLANT
- K051764 — T-PLATE ANTERIOR FIXATION SYSTEM
- K051776 — PROTEGE ULTRASONIC INSERT
- K041696 — RAPID READER
- K043428 — RELIADENT DENTAL IMPLANT SYSTEM
- K050379 — CS MEDICAL ADULT TTCF CATHETER
- K050592 — SOMNOMED MAS RXA
- K050968 — POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES
- K051009 — HUBER CLEAR SAFETY INFUSION SET
- K051011 — ENDOSSEOUS DENTAL IMPLANT ABUTMENT
- K051124 — ZILVER 635 BILIARY STENT
- K051147 — SIDEKICK BLOOD GLUCOSE TEST SYSTEM
- K051212 — MODIFICATION TO LNCS OXIMETRY SENSORS
- K051263 — EVITAXL WITH OPTION SMARTCARE
- K051311 — MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN
- K051339 — R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
- K051463 — XENO ADHESIVE WITH ACTIVATOR
- K051465 — POWDERED LATEX PATIENT EXAMINATION GLOVES
- K051550 — INSPIRATION VENTILATOR SYSTEM
- K051588 — BIOLOX DELTA CERAMIC FEMORAL HEADS
- K051663 — MALIBU SPINAL SYSTEM
- K033578 — REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS
- K033579 — REPROCESSED MULTIPLE CLIP APPLIERS
- K043035 — SEPRAGEL ENT BIORESORBABLE PACKING/STENT
- K050053 — HEMORAM/AGGRAM ANALYZER
- K050342 — THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
- K050887 — GONGDONG DISPOSABLE VAGINAL SPECULUM
- K050960 — MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
- K051068 — ZUTRON COLONOSCOPE STIFFENING DEVICE
- K051087 — DIMENSION VISTA INTEGRATED SYSTEM
- K051155 — SOLCO 4CIS GENERAL PLATE SYSTEM
- K051272 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML
- K051309 — ROI FUSION RODS & PLATES
- K051384 — MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM
- K051412 — HUMERAL HEAD PLATE WITH ANGULAR STABILITY
- K051621 — ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
- K051752 — ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
- K050502 — SINGLE USE BALLOON DILATOR MAXPASSTM
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