FDA 510(k) clearances — page 703
clearances on record, most recent first.
Clearances — page 703
70,201–70,300 of 176,637- K040609 — RAPID PROGRAMMER
- K040618 — LED TURBO
- K040628 — PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM
- K040670 — MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL
- K040694 — MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
- K032657 — TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)
- K033173 — MICRO TARGETING ELECTRODE
- K033644 — ENDOBOY
- K034035 — 3I PATIENT-SPECIFIC OVERDENTURE BAR
- K040050 — INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
- K040051 — MEGVISION, MODEL EQ1000C SERIES
- K040110 — EASY LOOP, MODEL EZL-01
- K040156 — IFL PROFESSIONAL SYSTEM, MODEL C100
- K040181 — ACCESS DHEA-S REAGENT ASSAY
- K040244 — MICROOPTICAL'S CRITICAL DATA VIEWERS, MODELS MD-3 AND MD-6
- K040245 — CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
- K040398 — SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS
- K040521 — MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH
- K040616 — CARDIOMD-AC
- K024213 — SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655
- K031304 — SYDNEY IVF PVP
- K033109 — ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS
- K033149 — ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
- K034045 — ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4
- K040064 — NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
- K040250 — BONE-LOK HP WASHER
- K040258 — SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
- K040284 — SUSTAIN RADIOLUCENT SPACER
- K040306 — HIGH VOLTAGE PULSED STIMULATOR, MODEL BMLS02-7
- K040448 — GENTLE SKIN AND (MULTIPLE LABELS) LATEX EXAMINATION GLOVE, POWDER FREE, POLYMER COATED WITH PROTEIN CLAIM
- K040462 — TRIGEN TROCHANTERIC ANTEGRADE NAIL
- K040531 — TERUMO SURGUARD2 SAFETY NEEDLE
- K040532 — POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR (SENSI-PRO)
- K040634 — ROBERTSITE VIAL ADAPTER, MODEL 245700021
- K040691 — INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D
- K031487 — MODEL AVANT 2120 PULSE OXIMETER AND NIBP
- K032292 — BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX
- K033000 — NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM
- K033454 — BRAHMS DIAGNOSTICA LUMITEST TRAK HUMAN
- K033694 — INFINITY MODULAR MONITORS VF4 MODIFICATIONS
- K033977 — ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM
- K034050 — CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F
- K040002 — MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1
- K040159 — APM BLOOD PRESSURE MONITOR, MODEL BP108A
- K040204 — ZYOPTIX XP MICROKERATOME
- K040205 — INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS
- K040541 — MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER
- K040577 — SOMATOM PROJECT P30L
- K040586 — MESACUP TEST MPO, MODEL 11053
- K040640 — MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL
- K023060 — ACCULASER PRO4
- K031084 — SOLAR GI SYSTEM
- K032086 — KRYO ART CONTROLLED RATE FREEZER
- K032863 — CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50
- K032864 — CERALAS D 810 DIODE LASER SYSTEM, MODEL D15
- K033389 — POWERPICC CATHETERS, MODELS 3175155, 3175135
- K033594 — OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
- K033954 — SHAPE LOCKING ENDOSCOPIC OVERTUBE
- K033998 — MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
- K034024 — TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS
- K040099 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
- K040173 — PEDIATRIC AORTIC ROOT CANNULA
- K040229 — A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODEL UB-328
- K040359 — HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
- K040373 — KERATO ANALYZER (EKA)
- K040422 — MODIFICATION TO VERTE-STACK
- K040547 — AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
- K040548 — AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
- K032509 — MARK 5 NUVO (M5C5)
- K032850 — IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)
- K032860 — IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
- K033200 — ARIOL
- K033208 — IVY DEVICES INC. IV/MEDICAL LINE STABILIZER
- K033297 — ZAP HCG TEST, MODEL 8001
- K033415 — IDI-MRSA
- K040036 — INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905
- K040073 — SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
- K040420 — DUCERAM PLUS CERAMIC SYSTEM
- K040421 — DUCERAGOLD PORCELAINS
- K040481 — SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1
- K040539 — ELLIPTIC MATRIX
- K040595 — ALICE 5
- K040631 — VITALAB DIRECT BILIRUBIN REAGENT
- K030624 — MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
- K031142 — DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
- K032451 — BIRD TBIRD VELA VENTILATOR
- K032671 — GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07
- K032896 — ANSON REFIX VASCULAR AND TISSUE CLIP, MODELS GF-04-01 AND GF-04-02
- K033291 — TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
- K033729 — COLLAGEN DENTAL WOUND DRESSINGS
- K033920 — CAAS II RVA
- K033923 — TH0R DDII IR LAMP SYSTEM
- K033955 — RTIST
- K040039 — NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM
- K040119 — PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION
- K040121 — DERMAWAVE 5000 COMBI MAX SYSTEM
- K040408 — POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING (LESS THAN 50 UG/G PER GLOVE)
- K040510 — VASCULAR SOLUTIONS D-STAT DRY 3X3 HEMOSTATIC PAD
- K040538 — BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996
- K040558 — MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
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