FDA 510(k) clearances — page 845
clearances on record, most recent first.
Clearances — page 845
84,401–84,500 of 176,637- K994286 — ZMR HIP SYSTEM-POROUS REVISION
- K994382 — NONLINEAR TAPER LAG SCREW
- K994392 — AEQUALIS SHOULDER FRACTURE SYSTEM
- K000544 — BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
- K000566 — MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK, VITRO IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS
- K000567 — ULTRASOUND SCANNER TYPE 2102
- K000656 — EMBRYON GIFT TRANSFER CATHETERS/SETS
- K992762 — BRACHYVISION 6.0
- K993946 — PEGASYS ULTRA
- K994270 — INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000
- K000497 — VOYAGER/VIPER WHEELCHAIR
- K000657 — LUER ACCESS UNIVERSAL VIAL ADAPTER
- K982558 — BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE
- K990718 — ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
- K990831 — SUPERGUARD SAFETY SYRINGE
- K991271 — OOCYTE ASPIRATION NEEDLE
- K992912 — CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH
- K992933 — LEMAITRE IRRIGATION CATHETER
- K993691 — ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
- K993894 — LIFECORE SINGLE TOOTH ABUTMENT SYSTEM
- K994323 — KAWASUMI LABORATORIES PHILEBOTOMY SET
- K994375 — HORIZON LIGHT
- K000250 — CAUTERY FORCEPS WITH FOOTSWITCH
- K000270 — ELECSYS CORTISOL TEST SYSTEM
- K000296 — STARION CAUTERY HOOK
- K000397 — SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL
- K000425 — ISOBAR SPINAL SYSTEM
- K000447 — QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
- K000513 — MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
- K000608 — SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM
- K991470 — MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM; INTERNAL CATALOG NUMBERS (1060)
- K992386 — ALLON 2000
- K993456 — SAS STREP A TEST
- K993584 — MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2
- K994167 — CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE)
- K994378 — AIRIS II
- K994428 — E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE
- K000384 — FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
- K000482 — MODIFICATION TO AUTOJECT MINI
- K991798 — ACME MEDICAL AESTHETIC ND:YAG LASER
- K992908 — Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
- K994128 — SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM
- K994142 — GRASS TS3201/6401 EEG AMPLIFIER SYSTEM
- K994152 — THE LIGAMENT ANCHOR SOFT SCREW
- K994203 — ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1
- K994299 — ART-P3, MODEL P3-1-ART-A1
- K994363 — INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)
- K000005 — IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6
- K000012 — IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
- K000076 — CELL-CHEX
- K000197 — CORTEK CYSTOSCOPE
- K000200 — CORTEK URETHEROSCOPE
- K000602 — PROTEGE WHEELCHAIR
- K993081 — IO-DRIVE
- K993557 — AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
- K993604 — ENDOSCOPIC ANTI FOG DEVICE
- K993957 — DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
- K994057 — SLENDAIR 4000 COMPRESSION SYSTEM
- K994125 — BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES
- K994341 — FIBRINOGEN CALIBRATOR KIT
- K994348 — KSEA SCB-RUI
- K994374 — SOAKER CATHETER
- K994429 — VENUSA, LTD. EXTENSION SET WITH FILTER
- K000175 — HARDYDISK TICARILLIN 75MCG
- K000181 — HARDYDISK, CARBENICILLIN, 100MCG
- K000226 — DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR
- K000231 — TRIAGE BNP CALIBRATION VERIFICATION CONTROLS
- K000378 — BACT/ALERT MB CULTURE BOTTLE
- K000387 — TERUMO NEEDLE WITH LOCKING SHEATH
- K993117 — SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG
- K993170 — MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS
- K993610 — CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
- K993811 — MULTISAFE POWDERED LATEX EXAMINATION GLOVES, NONSTERILE
- K993941 — UBAS
- K994144 — TOOTHBRUSH WASH
- K994170 — HYLASHIELD CL
- K994180 — PULPDENT CAVITY PREPARATION III
- K994282 — MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
- K994328 — SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
- K000011 — MODIFIED HYDROPHILIC COATED GUIDEWIRE
- K000073 — MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA
- K000276 — MPT 24 AND VITAL VIEW 24
- K000279 — STAPLETAC2 BONE ANCHOR SYSTEM
- K000343 — NAC Y-ADP
- K000477 — MDI DS-DNA TEST
- K000499 — ADVANTA SUPER SOFT GRAFT
- K000504 — ADVANTA SUPER SOFT GRAFT
- K000533 — VOCOM IMPLANT- 8MM
- K990330 — CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ
- K991684 — CHILLBUSTER PORTABLE ELECTRIC BLANKET SYSTEM, MODEL 8001
- K992524 — PATIENT CABLES FOR MONITORING, I.E., ECG, EKG, SPO2, AND BP INTERFACE CABLES AND LEADWIRES
- K992934 — LEMAITRE VENOUS THROMBECTOMY CATHETER
- K993189 — CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING
- K993694 — MIKRO-TIP ANGIOGRAPHIC CATHETER
- K994079 — REFLEX TREATMENT SYSTEM
- K994087 — SUPERSTITCH
- K994097 — MEDAMICUS EPIDURAL INTRODUCER
- K994151 — PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
- K994232 — PHALANGEAL FIXATION SYSTEM
- K994291 — DIMENSION SPECIAL PROTEIN CALIBRATOR
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