FDA 510(k) clearances — page 454
clearances on record, most recent first.
Clearances — page 454
45,301–45,400 of 175,770- K113410 — NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT
- K113490 — OPTIMA MR450W
- K113698 — SCEPTER XC OCCLUSION BALLOON CATHETER
- K120011 — HEISENBERG EFFECT SHADES
- K100437 — AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION
- K102439 — FUNNEL GUIDE CATHETER MODEL G1020608
- K110888 — ABSOLUTE WHITE LIGHT
- K111992 — CUROS PORT PROTECTOR
- K113085 — TRYLY AUTOMATIC WRIST BLOOD PRESSURE MONITOR
- K113123 — OIC CANNULATED SCREW SYSTEM, OIC SLIDING HIP SCREW (SHS) SYSTEM
- K113318 — ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM
- K113330 — CABLECAP
- K113654 — CASPIAN
- K113667 — CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
- K113679 — LUCEA LED SURGICAL LIGHT SYSTEM
- K113683 — LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL
- K113699 — TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED
- K111794 — REPROCESSED HARMONIC SCALPEL
- K112256 — STERIS STEAM PI
- K112811 — SANICLAVE 200
- K113069 — COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY
- K113405 — SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM
- K113460 — SYNERGY TISSUE MATRIX
- K113651 — INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
- K113681 — GLADIATOR PTA BALLOON DILATION CATHETER
- K103695 — PREPEX SYSTEM
- K110581 — PROPATCH SOFT TISSUE REPAIR MATRIX
- K110971 — TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT
- K111623 — I-ENDO DUAL
- K111761 — NEO TITANIUM MESH, CTI-MEM
- K112332 — FINE JECT INSULIN PEN NEEDLE
- K113138 — ALEUTIAN SYSTEM
- K113351 — CORTRAK ENTERAL ACCESS DEVICE
- K113625 — DSS STABILIZATION SYSTEM
- K113758 — VOLUSON E6/E8/E8EXPERT/E10
- K112258 — NEUROTECH PLUS
- K112514 — APNEA RISK EVALUATION SYSTEM (ARES)
- K112960 — LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE
- K113071 — SYNTHECEL DURA REPLACEMENT DEVICES
- K110559 — AVITA INFRARED THEROMETER WITH BLUETOOTH
- K111165 — KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE
- K111730 — SONOTT FLOWLAB(R)
- K111861 — SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE
- K112008 — TOUCHPACS SUITE
- K112046 — MTA ANGELUS
- K112060 — RADIANCE
- K112169 — APTUS WRIST ARTHRODESIS PLATES
- K112301 — ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
- K112523 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K113127 — MIRAGE QUATTRO
- K113137 — GLUCOSE TEST SYSTEM
- K113159 — U-RIGHT TD-1240 THERMOMETER
- K113477 — IVAS 20MM (10 GAUGE) BALLOON CATHETER
- K111103 — DIGITAL X-RAY IMAGING SYSTEM
- K111717 — ELECTRO-GEL
- K112035 — VALET MICRO CATHETER
- K112454 — HALO60 ABLATION CATHETER
- K112458 — PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM
- K112557 — STRYKER UNIVERSAL NEURO 3 SYSTEM
- K112955 — NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
- K113012 — PROMOS MODULAR SHOULDER SYSTEM
- K113038 — SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS
- K113242 — APEX ARC HIP STEM
- K113638 — NMI 2.8 MICROCATHETER
- K113708 — ORTHOSCAN MOBILE DI MINI C-ARM
- K112240 — DYNA LOCKING CANNULATED SCREW
- K112643 — FOCUS MIS SYSTEM
- K112890 — NORMATEC MVP
- K113106 — DNE EXTERNAL FIXATION SYSTEM
- K113187 — AVIVO MOBILE PATIENT MANAGEMENT
- K113211 — HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
- K113237 — CERTUS 140 2.45GHZ ABLATION SYSTEM
- K113589 — BIGBOSS CATHETER
- K113609 — NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
- K111068 — STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
- K111149 — HANAROSTENT BILIARY (NNN)
- K111403 — MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES
- K111985 — MYOGUIDE SYSTEM MODEL 8008
- K112522 — FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
- K112944 — FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES
- K113337 — VISIA DYNAMIC REVIEW
- K113373 — DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL
- K102999 — TRIMOTION INJECTOR
- K112543 — WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
- K112778 — SMART SEGMENTATION-KNOWLEDGE BASED CONTOURING
- K112914 — VPAP TX
- K113269 — ELITTECH CLINICAL SYSTEMS ALP IFCC SL
- K113342 — SOMATOM DEFINITION FLASH
- K113381 — MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM
- K113559 — LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS
- K113630 — DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA
- K113680 — SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT
- K113690 — GE LOGIQ I, LOGIQ E AND VIVID E
- K103573 — ARTS2 SPINAL FIXATION SYSTEM
- K110639 — ENDOWRIST ONE VESSEL SEALER
- K111618 — AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION
- K111671 — SEASPINE MONOPOLAR PROBE SYSYEM
- K111776 — DELTAVIEW MODEL 2.1
- K112080 — PRESERVE HIP STEM
- K112572 — GEISTLICH COMBI-KIT COLLEGEN
Data sourced from openFDA. This site is unofficial and independent of the FDA.