FDA 510(k) clearances — page 971
clearances on record, most recent first.
Clearances — page 971
97,001–97,100 of 175,890- K962766 — AIRSEP IMPULSE
- K962926 — ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY
- K962953 — DEODORANT PANTY SHIELD
- K962954 — DEODORANT MAXI PAD
- K962962 — DEODORANT PANTY LINER
- K963056 — ED-3410, VIDEO DUODENOSCOPE
- K963118 — EXTREMITY BONE SCREW
- K963180 — VIDAMED RF GENERATOR DATA RECORDER
- K963220 — TEMPRA COLD PACK, REORDER NO. TC150
- K963390 — BIOPSY INTRODUCER NEEDLE
- K963398 — ALTA FULLY THREADED CROSS-LOCKING SCREWS
- K963536 — SIGMA DIAGNOSTICS CALICIUM REAGENT
- K963752 — PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS
- K961841 — BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)
- K962006 — MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
- K962707 — MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET
- K962778 — THE L-BOW ARM RESTRAINT
- K962810 — GREAT HANDS MITTS
- K962886 — ANESTHESIA CONDUCTION NEEDLE
- K962921 — BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER
- K963084 — OPUS CMV TEST SYSTEM-MODIFICATION
- K963108 — HEELBO QUILTED TORSO RESTRAINT
- K963237 — HEELBO ICU 911 BLAZER SLEEVED JACKET
- K963457 — SLEEPER JACKET/HOUDINI SAFETY SLEEPER
- K963460 — ROLL BELT
- K946127 — OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
- K954584 — RACZ EPIDURAL CATHETER
- K954658 — PERNECZKY CLIP APPLIER/REMOVER
- K955520 — RESCUE BREATHER
- K955715 — CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
- K955877 — ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD
- K955891 — CARDIOVIEW TRANSTELEPHONIC SOFTWARE
- K960918 — VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM
- K960991 — ETEST SUBMISSION FOR AMOXICILLIN
- K961378 — DELTA HIP PROSTHESIS
- K961401 — HP CATHSTATION - MODEL M1264B
- K961463 — HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2
- K961590 — APEX UNIVERSAL IRRIGATION SYSTEM & TWO-CONNECTION TUBING SET
- K961647 — DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL
- K961769 — AIR-MEDEX I
- K962042 — GLASS SYRINGE
- K962098 — ESOPHAGEAL INTUBATION DETECTOR
- K962464 — SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY)
- K962497 — Q-TIPS, FAICHNEY, PRIVATE LABEL
- K962803 — APEX FINDER MODELS 7005
- K962941 — OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE
- K962966 — IDS RAPID CB PLUS SYSTEM
- K963123 — ARTHROCARE ARTHROSCOPIC ELETROSURGERY SYSTEM (MODEL 980)
- K963253 — SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K963455 — SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL
- K963456 — LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER
- K963499 — MIRROR FINISH BIPOLAR FORCEPS
- K963644 — A-1000 EEG MONITOR AND A-1050 EEG MONITOR
- K963681 — CCA-100 (MODIFIED)
- K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY
- K961415 — LATEX PATIENT EXAMINATION GLOVE (BLUE) (MODIFICATION)
- K961602 — LATEX PATIENT EXAMINATION GLOVE (PINK)
- K962146 — EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT
- K962286 — 2505 FACE MASK, TIE STRING / ANTI-FOG / FACE SHIELD
- K962411 — ONTRAK TESTCUP AMPHETAMINES
- K962647 — ANGLED ABUTMENT
- K962667 — CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR
- K962709 — SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/
- K962739 — T.B.Q.
- K962763 — 2000 MODULAR THIRTY-NINE
- K962812 — GLUMA DESENSITIZER/GLUMA 3 PRIMER
- K962849 — CATHETER INSERTION TRAY
- K962909 — DENTAL PREP WASH AND PREP DISINFECT
- K962956 — MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
- K963015 — SURGICAL STAPLE MARKER DEVICE (MODIFY)
- K963036 — MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD
- K963286 — IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT
- K963311 — TEAM ETCH
- K963427 — IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT
- K963447 — DOUBLE SUPPORT PONCHO/SLIDER PONCHO
- K963448 — ECONO BELT
- K963449 — PELVIC HOLDER
- K963450 — SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST
- K963454 — CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT
- K963551 — BIO-CSF LIQUID CONTROL LEVEL 1 AND 2
- K963583 — MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE
- K955685 — RNS STERILE, DISPOSABLE CT BIOPSY TRAY
- K961664 — COMPAT NASOJEJUNAL FEEDING TUBE
- K961821 — ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR
- K962173 — SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
- K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
- K962663 — SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET
- K962676 — DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE
- K962681 — ECOGEL 300 TENS GEL
- K962897 — EG-3400, VIDEO GASTROSCOPE
- K963355 — SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET
- K963377 — EOS BRAND DISPOSABLE VAGINAL SPECULUM-EOSSPEC
- K954490 — MERCURY MEDICAL CPR BAG EXHALATION FILTER
- K955596 — N LATEX B2-MICROGLOBULIN REAGENT
- K960425 — BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
- K961091 — KARL STORZ MODEL 203020 20 EQUIMAT
- K961094 — MITEK THREADED ANCHOR (MODIFICATION)
- K962233 — TWIST-OFF SCREW
- K962624 — RESOLUT REGENERATIVE MATERIAL
- K962639 — IMPRA CARBOFLO EPTFE VASCULAR GRAFT
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