FDA 510(k) clearances — page 885
clearances on record, most recent first.
Clearances — page 885
88,401–88,500 of 175,890- K982188 — STERI-PAK BOWIE DICK TEST PACK
- K982759 — AUTO-LYTE COCAINE METABOLITE EIA, MODEL # 1222U
- K982958 — ZETA MULTIZONE LOCKING NAIL SYSTEM
- K982963 — POLYMER THREADED ANCHOR / SUTURE COMBINATION
- K983252 — SYSTEM U3 FOR GENTAMICIN
- K983253 — PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT
- K983307 — MODIFICATION TO PORTABLE INTENSIVE CARE UNIT
- K983417 — ABBOTT ARCHITECT FREE T4
- K983434 — ABBOTT ARCHITECT TOTAL T3
- K983439 — ABBOTT ARCHITECT FREE T3
- K983442 — ABBOTT ARCHITECT TSH
- K983754 — STANDARD CHIN
- K983755 — NASAL DORSAL SERIES
- K983756 — SURGIFORM ANATOMICAL MALAR
- K983838 — ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
- K983981 — BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
- K984074 — ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05
- K974738 — ASTRA TECH IMPLANT DENTAL SYSTEM
- K982010 — FACTS
- K982243 — CANOGEN PORTABLE OXYGEN GENERATOR MODEL 615
- K982544 — RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
- K982937 — MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER
- K982941 — HEM-O-LOK MODEL NUMBERS 523900, 523970
- K982944 — HEM-O-LOCK, MODEL 523935
- K983064 — IMPRA HIGH POROSITY GRAFT
- K983282 — OMI OCCIPITAL CERVICAL LOOP, MODEL A1089
- K981199 — MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN
- K982315 — PROSPECT CAMPYLOBACTER MICROPLATE ASSAY
- K982362 — ABBOTT TESTPACK PLUS H. PYLORI
- K982431 — NMT SAFETY SYRINGE
- K982657 — AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100
- K982745 — AUTO-LYTE BARBITURATES EIA
- K982946 — PAINBUSTER INFUSION KIT
- K983049 — AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER
- K983051 — AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
- K983087 — BREATHTIQUE TONGUE SCRAPER
- K983090 — ACON MIDSTREAM PREGNANCY TEST
- K983113 — BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
- K983168 — AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200
- K983174 — ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
- K983188 — DBEST TETRAHYDROCANNABINOL TEST KIT
- K983189 — DBEST METHAMPHETAMINES TEST KIT
- K983190 — DBEST OPIATES TEST KIT
- K983191 — DBEST COCAINE TEST KIT
- K983212 — ABBOTT ARCHITECT TESTOSTERONE
- K983262 — FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS
- K983268 — MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
- K983269 — FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER
- K983271 — FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS
- K983358 — G/K SFN AND STN LOCKING NAILS
- K983370 — PRODIGY- 3
- K983376 — THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S
- K983378 — THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR.
- K983388 — ONTRAK TESTCUP-ER
- K983390 — IS-ANTI-MPO IGG ELISA TEST SYSTEM
- K983418 — THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL
- K983420 — THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO
- K983422 — THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET
- K983423 — THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K983425 — THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET
- K983426 — THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC
- K983453 — PROCERA ALLCERAM FUSING MATERIAL
- K983464 — THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K983465 — THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
- K983545 — QUADRANT UNIBOND
- K983669 — OPTICAL TRACKING SYSTEM WITH SURFACE MATCHING MODULE, MODEL OTS
- K983740 — IS-ANTI-PR3 IGG ELISA TEST SYSTEM
- K983850 — DIMENSION AHDL CALIBRATOR
- K983894 — BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS
- K983971 — CARDIAC MARKER CONTROL MODULE, MODEL CCCM
- K980492 — AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
- K980551 — SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
- K981853 — BONE INJECTION GUN (B.I.G.) DEVICE
- K982168 — SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
- K983046 — AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER
- K983048 — AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER
- K983125 — EPIDURAL CATHETER MODELS 1210/1200
- K983855 — FUZZY TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL #'S HD-1000S & HD-2000F
- K980045 — CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
- K980182 — WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
- K982610 — OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT)
- K982911 — FORTE
- K982924 — DUREX SENSIDOM LATEX CONDOM
- K982972 — SIGNA PROFILE SMALL HEAD COIL
- K982994 — SKULL BASE INSTATRAK SYSTEM
- K983111 — XRAY VISION
- K983143 — MARK 5000 PHASED ARRAY SHOULDER COIL
- K983181 — CYTOPREP
- K983380 — DUREX LUBRAGEL LATEX CONDOM
- K983428 — SAFETEX CERVICAL SCRAPER (PLASTIC)
- K983617 — 25-HYDROXYVITAMIN D 125I RIA KIT
- K983659 — PLANMED SOPHIE & PLANNED SOPHIE CLASSIC
- K983812 — NAPA EIA ASSAY
- K983848 — ABBOTT AXSYM MYOGLOBIN
- K983980 — SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS
- K970811 — DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA;DISPOSABLE CANNULA FENESTRATED TRACHEOSTOMY TUBE, WITH INNER CN
- K973171 — NIR BILIARY STENT
- K981964 — MEDI-TRACE 4103 NEONATAL ELECTRODE
- K982803 — HEARTLINK, MODEL II
- K983021 — METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC
Data sourced from openFDA. This site is unofficial and independent of the FDA.