FDA 510(k) clearances — page 945
clearances on record, most recent first.
Clearances — page 945
94,401–94,500 of 175,890- K970667 — NUVO-LASE 660 LASER SYSTEM
- K970699 — AURORA SUNGLASSES,SKI GOGGLES AND PROTECTIVE/SAFTEY GOGGLES
- K970724 — QUICKPAC II ONE STEP METHAMPHETAMINE TEST
- K970914 — CHASE AORTIC PERFUSION CANNULA
- K971041 — CHASE CORONARY OSTIAL PERFUSION CANNULA
- K971208 — MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS
- K971412 — SUNGLASSES
- K961631 — ODONT HEX SYSTEM
- K963340 — MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE
- K970094 — MODEL DX MICRO COMPUTER CONTROL
- K970509 — INNOFLOUR CALIBRATOR REAGENT SET
- K970510 — INNOFLOUR TOPIRAMATE REAGENT SET
- K970517 — INNOFLUOR TOPIRAMATE CONTROL SET
- K970536 — MEDISYSTEMS TRANDUCER PROTECTOR
- K970556 — SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM
- K970564 — DYNAMIC WEDGE
- K970586 — BRAINLAB MICRO MULTI-LEAF COLLIMATOR
- K970628 — GE ADVANTAGE DIGITIZER WORKSTATION
- K970702 — SPECTRUM DESIGNS SPECTRAGEL
- K971236 — GREINER VACUETTE BLOOD COLLECTION TUBE
- K971239 — GREINER VACUETTE BLOOD COLLECTION TUBE
- K971353 — DSL ACTIVE NON-EXTRACTION IGF-I ELISA
- K954577 — WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS
- K961608 — SYNTHES (U.S.A.) POLYPIN
- K961805 — TOMEY DTL ELECTRODE
- K963256 — NEUROMATE STEREOTACTIC SYSTEM
- K964239 — COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER
- K964302 — HEARTPORT THORACIC TROCAR
- K964644 — AD-TECH'S DEPTH ELECTRODE
- K964710 — BLEDSOE COLD CONTROL
- K964781 — IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
- K965103 — WINMAX SOFTWARE SYSTEMS
- K970426 — VALUETRODE
- K970441 — K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH
- K970494 — HANNIBAL GUIDEWIRE
- K970496 — HEARTPORT MAZE SYSTEM: CRYOPROBE SET
- K970516 — SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM
- K970587 — AD-TECH SUBDURAL ELECTRODE
- K970710 — STAT PROFILE ULTRA M ANALYZER
- K970725 — OPTI-PLAST XL 5.5 F PTA CATHETER
- K970746 — SEE3 (LOTRAFILCON A) SOFT CONTACT LENS
- K970748 — TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM
- K970757 — FOTONA SKINSCAN
- K970779 — OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
- K970982 — T-RX RETRIEVAL FORCEPS
- K971048 — PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
- K971327 — UNIKA
- K971389 — ECLIPSE 400 MANUALLY OPERATED WHEELCAIR
- K960441 — STERITEC INTEGRAPH MODEL CI-101
- K964069 — DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
- K965102 — ACROMED PEDICLE SCREW
- K965224 — EMPOWER ANTERIOR DIRECT SCREWS
- K970455 — DUKAL NON ADHERENT DRESSING
- K970457 — DUKAL ABD COMBINE PAD
- K970469 — EVT ANGIOSCALE ANGIOGRAPHIC CATHETER
- K970545 — DASH 1000 PATIENT MONITOR
- K970600 — DERMAMEND FOAM ISLAND DRESSING
- K970692 — UNITRON MODEL SOUND F/X CIC
- K970717 — VAPOR-TECH SLED ELECTRODE
- K970813 — DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111
- K970884 — RESOLUT REGENERATIVE MATERIAL
- K971196 — ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K971286 — EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST
- K971287 — SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
- K971297 — CENTRE-DRIVE DRILL-FREE SCREW
- K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
- K954220 — EUB-8000
- K962317 — MAGNES 2500 WH BIOMAGNETOMETER
- K963562 — WRIGHT PLASTER OF PARIS PELLETS
- K963622 — VAIL 2000 ENCLOSED BED
- K963962 — VISTA BRITE TIP CATHETERS
- K964814 — BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
- K970249 — SIMPLEX AIRBRATOR
- K970432 — INFANT RADIANT WARMER - MODELS IW910 AND IW920
- K970684 — LACTATE DEHYDROGENASE (LD)
- K970738 — KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT
- K970945 — ANGLED TIP POLYPECTOMY SNARE
- K970986 — WAKO DIRECT BILIRUBIN V
- K955622 — AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM;
- K955816 — VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
- K960738 — STERITITE SEALED CONTAINER(SC08F,SC06F,SC04F,SC08Q,SC06Q,SC04Q,SC08H,SC06H,SC04H)
- K963396 — BIOSPHERE SUTURE ANCHOR
- K964033 — 3F ANGIOPTIC ANGIOGRAPHIC CATHETER
- K964034 — TRANSJUGULAR ACCESS SET
- K964114 — DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
- K964188 — HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT
- K964256 — CYGNUS INSTRUMENT PROTECTORS
- K964976 — FLOSSBRUSH WITH FLUORIDE
- K970104 — SANI-SHIELD
- K970315 — EVEREST SUNGLASSES
- K970368 — SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
- K970454 — LAXIMA INTERNATIONAL LIMITED SUNGLASSES
- K970463 — CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR
- K970476 — HWA MAO OPTICAL SUNGLASSES (NON-PRESCRIPTION)
- K970620 — CORDIS OPTA5 PTA BALLOON CATHETER
- K970670 — REUSABLE VITRECTOMY PROBE
- K970698 — BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS
- K970759 — SOLAR SPECS
- K970794 — LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)
- K970848 — SILOC SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.