FDA 510(k) clearances — page 806
clearances on record, most recent first.
Clearances — page 806
80,501–80,600 of 176,637- K010470 — R & D 4K RETIC
- K010552 — CG-900P FETAL/MATERNAL MONITOR
- K010803 — POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
- K011006 — AMYSEAT TILT/RECLINE SEATING
- K011227 — REGAL MOTOTRIZED 3 WHEELED VEHICLE
- K003400 — CRP HS TEST SYSTEM
- K003754 — IMMUNETICS C6 LYME ELISA KIT
- K010291 — ITI DENTAL IMPLANT SYSTEM
- K010458 — THE MAESTRO SYSTEM
- K010696 — BECKMAN COULTER DNASE B CALIBRATOR
- K010794 — BRIDGE III RECEIVER
- K010816 — DENTO-PREP PARTICLE MICROBLASTER
- K010879 — UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K011036 — RD-3008
- K011084 — MANDREL GUIDEWIRE ASSEMBLY
- K011163 — MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
- K011164 — MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
- K011166 — MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
- K010380 — MP3HD BIG BOY, POWER WHEELCHAIR
- K010420 — RUSCH MMG/O'NEIL CATHETER
- K010633 — RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
- K011065 — INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
- K011077 — ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22)
- K001120 — ENVOY PATIENT MONITOR
- K002824 — MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
- K003043 — SURGICAL TITANIUM MESH SYSTEM
- K003735 — BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
- K010369 — CLARIS PLATE SYSTEM
- K010472 — PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50
- K010479 — MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
- K010542 — SNN SYSTEM INCLUDING THE TOMOGUIDE OPTION
- K010595 — DJ ORTHOPEDICS INTERFERENCE SCREW
- K010691 — BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION
- K010700 — RANDOX MYOGLOBIN
- K010825 — MEDLINE STERISET STERILIZATION CONTAINER
- K011039 — OMNILINK .018 BILIARY STENT SYSTEM
- K011097 — QUICKVUE DIPSTICK STREP A
- K011120 — GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES
- K011142 — AQUARIUS WORKSTATION
- K011204 — NEUROFAX, MODELS EEG-1100A, EEG-9100A
- K011267 — EXHALE RF PROBE
- K011271 — POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED
- K003403 — ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999
- K003405 — ENDOSCOPIC MONOPOLAR FORCEPS-SCISSORS, EMF-2000 TO 2999,ENDOSCOPICS MONOPOLARFOEPS-GRASPERS, EMF-3000 TO 3999, ENDOSCOPO
- K010361 — MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
- K010475 — D/C CORE MATERIAL
- K010520 — GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
- K010582 — ACON STREP A RAPID TEST STRIP
- K010605 — ATLAST DATA MANAGEMENT SOFTWARE (DMS)
- K010666 — XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
- K010677 — XPS 3000 SYSTEM
- K010813 — SIMPLICT
- K002193 — TETRAD TC-C3-ACP
- K002763 — REMREST
- K002801 — MPS M ELECTRODE
- K003123 — RENAX A.V. FISTULA NEEDLE SETS
- K003442 — MODIFICATION TO EDI VERIS SYSTEM
- K003626 — DEVILBISS HUMIDIFIER
- K003943 — MICROGAS 7650 TRANSCUTANEOUS MONITOR
- K010449 — IVD (IN VIVO DOSIMETER), MODEL 1131
- K011050 — MICROSTREAM ORAL NASAL CANNULA FILTERLINE
- K011067 — MODIFICATION TO TSRH SPINAL SYSTEM
- K011098 — REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
- K011136 — APEX FIXATION PINS
- K011178 — WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR
- K011224 — HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY
- K001807 — TISSUE MARKER
- K002256 — ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
- K002565 — BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)
- K003458 — SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
- K003528 — SANARUS CORE TISSUE BIOPSY SYSTEM
- K010344 — ADJUSTABLE LARGE FIXATOR SYSTEM
- K010348 — TANTALUM BEADS - RADIOGRAPHIC MARKER
- K010483 — POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0
- K010487 — BIPOLAR PENCIL, MODEL 3901-002, 3900-002
- K010499 — SYNTHES (USA) MIDFACE DISTRACTOR
- K010638 — NEUROPLUS, MODEL A10040, A10041, A10042, A10043
- K010661 — MODIFICATION TO TISSUELINK BIPOLAR FORCEPS
- K010695 — KOALA CLAMP
- K010863 — LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER)
- K010867 — KILEJIAN CIRCUMCISOR
- K010991 — SEEDNET, MODELS FP6T5, FP5T5, FP5T3
- K011157 — COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT
- K002186 — VASCULAR ASSIST
- K002334 — MACROPORENS CRANILOC
- K002817 — SYNETEC
- K003320 — PTA-OS SIZING BALLOON, MODEL 360
- K003819 — HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
- K010183 — GLOBAL BY <GENX> BLASTOCYST MEDIA
- K010244 — SURE CHECK OVULATION PREDICTOR
- K010305 — WEISS RETINAL CANNULA
- K010321 — MODULAR FOOT SYSTEM - 2.7 MM MODULE
- K010322 — ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
- K010346 — KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
- K010975 — ECLIPSE 6.5
- K011009 — WHITE MTA MATERIAL
- K011022 — BIOUNIVERSAL PDF
- K011023 — D.SIGN 96
- K011088 — SIII ALARM AMPLIFIER
- K011115 — KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010
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