FDA 510(k) clearances — page 907
clearances on record, most recent first.
Clearances — page 907
90,601–90,700 of 176,637- K981536 — QUANTECH MYOGLOBIN ASSAY
- K981650 — AST/SGOT LIQUID REAGENT - KINETIC METHOD
- K981652 — CHOL
- K981769 — HICHEM PHOSPHORUS REAGENT KIT
- K981843 — AST
- K981872 — SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40
- K981906 — MODIFICATION FOR PTA BALLOON CATHETER
- K981933 — URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2
- K982024 — OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
- K982071 — I-STAT LACTATE TEST
- K963440 — DIALOG DIALYSIS MACHINE
- K964514 — CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS
- K965117 — LIFE SUPPORT FOR TRAUMA AND TRANSPORT
- K973298 — CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER
- K974178 — PASSPORT 5L-CE MODEL 0998-00-0131XXX
- K980132 — PHYTACARE ALGINATE HYDROGEL WOUND DRESSING
- K980779 — THALAFIX NATURAL SEA SALT DRESSING
- K980813 — RELIANCE LONG STEM FEMORAL COMPONENTS
- K981131 — PATHFINDER MOBILE C ARM
- K981214 — OSTEOGRAF/N-700
- K981728 — ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
- K981833 — SILIMED NASAL L SHAPED IMPLANT
- K981859 — SURGIFLATOR-20 ECU
- K961320 — CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM
- K980580 — BECTON DICKINSON SYRINGES
- K980948 — VED VALU- VACUUM ERECTION DEVICE
- K981114 — MICROCAP
- K981115 — RADIO-PLAST
- K981126 — CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G3
- K981140 — MINRAD DRTS LIGHT SABER SYRINGE
- K981271 — CLEARPLAN EASY OVULATION TEST
- K981275 — SYNTHES (USA) RATCHETING DISTRACTOR
- K981302 — SMC 28MM CERAMIC FEMORAL HEADS
- K981433 — ORTHODONTIC BRACES
- K981443 — BIOSIGN HCG I - ONE STEP PREGNANCY TEST
- K981461 — GC FUJI ORTHO LC
- K981476 — CHOL
- K981506 — RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)
- K981604 — CARESIDE URIC ACID
- K981610 — CARESIDE ANALYZER
- K981838 — ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002
- K981902 — SPENCO SILICONE GEL SHEET
- K981935 — POLYSORB SUTURE
- K982009 — ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE
- K982097 — WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD
- K974417 — SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM
- K974593 — SEMKIN INSULATED BIPOLAR FORCEP
- K974594 — SEMKIN BIPOLAR FORCEP
- K974595 — CUSHING BAYONET, INSULATED BIPOLAR FORCEP
- K974735 — STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE
- K980591 — RENU MULTIPLUS LUBRICATING & REWETTING DROPS
- K981269 — UNIVERSAL DRIVE SYSTEM
- K981416 — MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15
- K981779 — CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT
- K981822 — DRS SYSTEM
- K982035 — OLYMPUS CALCIUM ARSENAZO III REAGENT
- K982056 — RAICHEM CO2 REAGENT
- K982174 — VENTURI VENTILATOR
- K980814 — PURESPERM
- K981063 — AUTOMATED CORNEAL TREPHINE
- K981103 — TURBOSONICS LIMITED REUSE ULTRASONIC TIP
- K981252 — OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)
- K981265 — PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA
- K981588 — CARESIDE TOTAL BILIRUBIN
- K982127 — POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
- K973251 — KSEA CALCUSON
- K974251 — X-CELL WOUND DRESSING
- K974321 — HYDROTONE
- K974468 — PHOTONIC STIMULATOR
- K981075 — SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET
- K981150 — SOLOSITE GEL CONFORMABLE DRESSING
- K981151 — OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392
- K981166 — ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214
- K981184 — SHARPTRACK REUSABLE SHARPS CONTAINER
- K981261 — HOWMEDICA SCN NAIL
- K981304 — NITRILON CORRECT-TOUCH
- K981309 — OSTEO I-C HUMERAL NAIL SYSTEM
- K981333 — NITRILON CORRECT-TOUCH
- K981340 — INNOVASIVE DEVICES MENISCAL DART REPAIR SYSTEM
- K981467 — AMM
- K981670 — DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW
- K981724 — O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100
- K981806 — ALKP
- K981893 — HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES
- K981990 — MRS-400, MAXI 400, MRSL-400, MAXI 400L
- K973013 — OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER
- K980728 — FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM
- K980873 — KONICA DIRECT DIGITIZER REGIUS MODEL 330
- K981286 — SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
- K981328 — QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
- K981330 — QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
- K981470 — WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE
- K981621 — ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
- K981766 — URIC ACID
- K974843 — DURACON(R) SMALL STABILIZER TIBIAL INSERT
- K980002 — KOALA VASCULAR CLAMPS AND INSERTS
- K981053 — KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW
- K981094 — MEDRAD NEUROVASCULAR COIL
- K981167 — STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT
- K981217 — PLATINUM READING, REVIEW & ANALYSIS WORKSTATION
Data sourced from openFDA. This site is unofficial and independent of the FDA.