FDA 510(k) clearances — page 412
clearances on record, most recent first.
Clearances — page 412
41,101–41,200 of 175,770- K123082 — MOBILECT VIEWER
- K123400 — AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE
- K123736 — CRYSTALSERT DELIVERY SYSTEM
- K124040 — FORACARE GD20 BLOOD GLUCOSE MONITORING SYSTEM
- K130639 — ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER
- K130909 — GATEWAY ADVANAGE Y-ADAPTER
- K130924 — BRUXZIR SHADED
- K131118 — 4D VIEW
- K131224 — SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE
- K120615 — ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE
- K122493 — GENESISPLUS
- K122777 — NBX - NON BRIDGING EXTERNAL FIXATOR HAND
- K123542 — PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
- K123586 — EASYRA CREATININE REAGENT
- K123617 — 3F PRO-PICC
- K123800 — WRIST AUTOMATIC BLOOD PRESSURE MONITOR
- K123930 — VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
- K130366 — BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
- K130463 — UCP HOME DRUG SCREENING TEST; CARDS, CUPS
- K130734 — SAUFLON MULTIPURPOSE SOLUTION
- K122785 — HYDROSIL; MAGIC; PERSONAL CATHETER
- K123077 — VASCULAR CLAMPS
- K123551 — ITCLAMP 50
- K123912 — KOBOLD FLETCHER TYPE APPLICATOR SET, KOBOLD HENSCHKE TYPE APPLICATOR SET
- K123985 — SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100
- K124022 — SPEED SHIFT
- K130479 — ILIZAROV DRILL TIP WIRES
- K130729 — EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
- K131107 — ATRICLIP GILLINOV-COSGROVE LAA CLIP
- K120756 — LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE
- K122013 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M)
- K122635 — TORNIER INSITE FT BIOCOMPOSITE SUTURE ANCHOR
- K123629 — FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES
- K123903 — BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
- K123913 — LATIS SPACER
- K124058 — CREO STABILIZATION SYSTEM
- K130159 — QLAB QUANTIFICATION SOFTWARE HEART MODEL
- K130282 — REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT
- K130506 — IMSE P-TLIF
- K131099 — AG MASS
- K121203 — BOSTON KERATOPROSTHESIS OR BOSTON KPRO
- K121467 — EUROTROL HEMATOCRIT CONTROL
- K121719 — SM TENS & PMS
- K123381 — HYPERION X9
- K123478 — STINGRAY BIPOLAR FORCEPS
- K123769 — ZX-I POWER ADD ON
- K123871 — FINGERTIP PULSE OXIMETER
- K130192 — NEXTSTEP RETROGRADE
- K130289 — TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
- K130617 — RAYSTATION
- DEN120022 — X-RAY ATTENUATING CREAM
- K122774 — SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG
- K123581 — NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN
- K123710 — UNITOX BOTOX SYRINGE
- K130661 — ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
- K130796 — VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
- K130830 — INTEGRA LAMINOPLASTY SYSTEM
- K130990 — VARIANT(TM) II TURBO HBA1C KIT - 2.0
- K131020 — TEMPERATURE SENSOR CATHETER
- K131030 — RANGE SPINAL SYSTEM
- K131038 — NMI PICC MAXIMAL BARRIER NURSING KITS
- K122877 — RANGE SPINAL SYSTEM, SMALL STATURE
- K123079 — OLYMPIC BRAINZ MONITOR
- K123095 — MEDLINE BLOOD PRESSURE TRANSDUCER
- K123684 — SOL-CARE SAFETY NEEDLE
- K130513 — VOLISTA 400; VOLISTA 600
- K130655 — RESPONSE SPINE SYSTEM
- K130763 — BEACON TISSUE MARKER
- K130964 — GRIDLOCK PLATING SYSTEM
- K120590 — DILATOR TUBE SET
- K122064 — FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE
- K122343 — PUREFLUX-H HEMODIALYZER
- K122707 — HOVERROUND TEKNIQUE
- K122741 — HOVEROUND TEKNIQUE
- K122923 — QUANTA FLASH ENA7
- K123368 — LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
- K123748 — ABL90 FLEX
- K130326 — TEPHAFLEX MELTBLOWN CONSTRUCT
- K130494 — UNITRON TINNITUS MASKER FEATURE
- K130624 — CONI
- K130825 — AZURE ANTERIOR CERVICAL PLATE SYSTEM
- K131009 — PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)
- K121702 — ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE
- K122404 — MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26
- K124016 — EMPI PHOENIX
- K130963 — LIQUICHEK PEDIATRIC CONTROL, LEVEL 1; LIQUICHEK PEDIATRIC CONTOL, LEVEL 2; LIQUICHEK PEDIATRIC CONTROL, BILEVEL MINIPAK
- K113539 — REVOIS PRO IMPLANT STSYEM
- K120597 — KOMPREDA
- K121243 — ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER
- K121404 — SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM
- K122416 — ARTIGLASS L. O.R. GLASS SYRINGE
- K122500 — NEO PS KNEE SYSTEM
- K122559 — BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS
- K122721 — AG GUFFILL
- K123159 — SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS
- K123486 — TRIATHLON TRITANIUM TIBIAL BASEPLATE
- K123600 — DIGITAL BLOOD PRESSURE MONITOR
- K123926 — METASURG NITINOL STAPLE IMPLANT
- K130084 — MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM
- K130147 — ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)
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