FDA 510(k) clearances — page 507
clearances on record, most recent first.
Clearances — page 507
50,601–50,700 of 175,825- K100745 — LIFEBED NETWORK PATIENT VIGILANCE SYSTEM
- K090301 — BINAXNOW PBP2A TEST, MODEL 890-000
- K093361 — SYNTHES AIR PEN DRIVE (APD) SYSTEM
- K093746 — VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM
- K093904 — GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER
- K093907 — WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE
- K100104 — HYBERNITE RAINOUT CONTROL SYSTEM
- K100108 — AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA
- K100272 — INTELLIVUE CLINICAL INFORMATION PORTFOLIO
- K100362 — CAMBRIDGE HEART OEM
- K100747 — CONTREX PLUS LOW CONTROL SOLUTION
- K100881 — SYNAPSE OBLIQUUS MIP/MPR/FUSION
- K092521 — ZUMA-C
- K093554 — RETROFLEX DILATOR KIT
- K093695 — PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE
- K093697 — VASHE WOUND THERAPY SOLUTION
- K100145 — A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06
- K100392 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K090975 — DEROYAL NON-LOCKING BONE FIXATION SYSTEM
- K091022 — MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT
- K092066 — PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE
- K100081 — ENTEROSCOPY OVERTUBE, MODEL 00712140
- K100084 — MULTI FRAME WHEELCHAIR
- K100111 — NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
- K100384 — FIBERLASE C02 LASER WAVEGUIDE
- K100737 — MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM
- K100892 — RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
- K091720 — SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM
- K092335 — PEAK EXPIRATORY FLOW METER, KN-9710
- K093802 — ULTRAVIEW DM3 MONITOR
- K093932 — ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH
- K100252 — MASTER-VU A-SCAN, MV4500
- K100264 — T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060
- K100284 — LIQUIBAND ULTIMA, LUT 003
- K100683 — NEUROLINK IP MODEL: PK1117
- K091772 — POWDER-FREE VINYL EXAM GLOVES
- K092348 — POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS
- K092351 — POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS
- K093229 — CATHETER CONNECTIONS DUALCAP
- K093288 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
- K093394 — BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C
- K093680 — DIAZYME CYSTATIN C ASSAY
- K093806 — MYKNEE CUTTING BLOCKS
- K094007 — UNICEM
- K100046 — M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000
- K100250 — XCERAM
- K100335 — ORS VISUAL
- K100417 — XKNIFE 5
- K100676 — SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL
- K100701 — SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277
- K090845 — APEX ARC HIP STEM
- K091791 — PROVANT SYSTEM, MODEL 4201
- K092765 — LANX ANTERIOR PLATING SYSTEM
- K092984 — PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
- K093243 — COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
- K093279 — NAVIX ACCESS DEVICE
- K093441 — DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
- K093845 — ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25
- K094041 — ALPHA ORTHOPAEDICS AT3 SYSTEM
- K100215 — ARCHIMED REMEDY CERVICAL PLATE
- K100224 — ESTECH COBRA BIPOLSR II
- K100597 — HARMONIC FOCUS SHEARS
- K100662 — FEMVUE CORNUAL BALLOON CATHETER
- K091770 — VINYL PATIENT EXAM GLOVES PRE-POWERED, CLEAR
- K093176 — MED-LOK
- K093913 — MERCURY MEDICAL T-PIECE RESUSCITATOR
- K100419 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K100673 — EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
- K100692 — DIGITAL SPOT MAMMOGRAPHY SYSTEM
- K083312 — MINIHIP STEM
- K090036 — SYSTEM 1.5 STERILE PROCESSING SYSTEM
- K092387 — MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
- K092578 — LIFEGLOBAL PROTEIN SUPPLEMENT
- K093341 — CENTURY MODEL 105C
- K093371 — MODEL DGH 6000 SCANMATE A
- K093632 — INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE
- K093790 — SIMONDR DRP
- K093935 — SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR
- K100023 — PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
- K100164 — MR INSPIRE WITH EXTENDED KIT
- K100599 — CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM
- K100670 — S-SCAN, MODEL 9800020010
- K083785 — VITALA CONTINENCE CONTROL DEVICE
- K091716 — MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY
- K091933 — ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
- K091955 — STRYKER SONICPIN SYSTEM
- K092076 — AEGIS & AEGIS II SPINAL SYSTEM
- K092481 — HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
- K092484 — HELIOX LOW FLOW SENTRY BLENDER
- K092530 — SPRYTIE, MODELS ST001, ST002 AND ST003
- K092579 — INTRAUTERINE INSEMINATION (IUI) CATHETER
- K092785 — COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301
- K093135 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE
- K093305 — ENHANCED ULTRA VIT PROBE
- K093321 — BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM
- K093333 — PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8
- K093555 — COBAS U411 TEST SYSTEM
- K093706 — PROXISCAN MODEL 101
- K093858 — PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
- K100120 — ALEXIS ORTHOPAEDIC WOUND RETRACTOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.