FDA 510(k) clearances — page 1335
clearances on record, most recent first.
Clearances — page 1335
133,401–133,500 of 176,637- K874232 — MUSCLE STIM. DEVICES, BM 2000,4000,6000,8000
- K881470 — SOKEN PLUS(TM) ELECTRONIC MUSCLE STIMULATOR
- K881604 — VENA CAVA FILTER
- K883281 — VIRGO HSV-2 IGG ELISA
- K883282 — VIRGO HSV-1 IGG ELISA
- K883427 — VIRGO(R) VZV-IGG ELISA
- K884218 — AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
- K884402 — EXTRA STRENGTH SKIN LESS SKIN CONDOM
- K884757 — CLINISTAT CHOLESTEROL REAGENT TEST
- K884981 — F40 K KARAYA GUM DISP. PE-FOAM ECG ELECTRODE, 40MM
- K884982 — M68 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE,68
- K885092 — BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002
- K885247 — STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR
- K890277 — HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT
- K890504 — CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS
- K890538 — GUARDS LATEX & SAFE-CONTACT EXAMINATION GLOVES
- K890578 — HI CHEM WASH CONCENTRATE REAGENT #88805
- K890726 — TRACHEOSTOMY CARE AND CLEANING KITS
- K890727 — NON-STERILE, BULK GAUZE SPONGES
- K890734 — DRY TIPS
- K890785 — ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
- K890886 — ABUSCREEN FP FOR AMPHETAMINE
- K881970 — MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
- K883732 — ARGIS PULMONARY FUNCTION TESTING SYSTEM
- K883903 — NR2000 CARDIAC MONITOR
- K884455 — MODEL 702 ECG/RESPIRATION/TEMPERATURE
- K884504 — ELECTRODE GEL
- K884867 — OPTIFIELD I AND II AUTOMATED PERIMETERS
- K884897 — FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
- K884917 — RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM
- K884983 — M55 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 55
- K884984 — M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40
- K885135 — MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150
- K885183 — ENDOSCOPIC LIGHT SOURCE
- K885274 — ROCKET ENDOCERVICAL BRUSH
- K890081 — CALIUS-ISABEL CANOVAS SUNGLASSES
- K890131 — TARGET(TM) QUANTITATIVE HCG
- K890278 — TOTAL PROTEIN REAGENT
- K890337 — TRIGLYCERIDES - GPO REAGENT
- K890421 — IMX B2-MICROGLOBULIN
- K890529 — ALASTIGARD
- K890558 — WELLSHIRE BASELINK
- K890568 — ULTIMA LITE
- K890569 — NEYORO 65CF
- K890576 — KENLOR HUMAN SPINAL FLUID CONTROL LIQUID
- K890577 — KENLOR LIQUID URINE CONTROL
- K890704 — BTE HEARING AID OTICON MODEL: E42P
- K890705 — MEDIMOD(TM), MODEL 8900
- K890884 — ABUSCREEN FP FOR BARBITURATES
- K890957 — HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:
- K883814 — DELFIA HLH SPEC KIT
- K884133 — PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP
- K884489 — C&T PREGNANCY TEST KIT
- K884528 — SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES
- K884724 — ASPARTATE AMINOTRANSFERASE (AST)
- K884809 — DELFIA SHBG KIT
- K885187 — MODEL 1000 ELECTRONIC CLINICAL THERMOMETER
- K885307 — FLIPSCREEN (TM) TOTAL E IMMUNOASSAY
- K885334 — VAC-RITE
- K890203 — ADMS BIOPSY NEEDLE
- K890269 — ALKALINE PHOSPHATASE ISOENZYME REAGENTS
- K890317 — TOTAL PROTEIN REAGENT
- K890327 — BIOPSY NEEDLE GUIDE ATTACHMENT
- K890395 — BIOTROL IRON REAGENT
- K890442 — SHAPE-ACTIO URINALYSIS CONTROLS
- K890457 — MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP
- K890534 — MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1
- K890645 — ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT
- K890669 — STATSPIN HDL-CHOLESTEROL PRECIPITATING MICRO TUBE
- K890748 — ALLEVYN TRACHEOSTOMY DRESSING
- K883158 — RESPIRATORY AIRWAY TUBE MONITOR (RATM)
- K884106 — SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
- K884740 — EURO-MED LIGHT TOUCH BIOPSY PUNCH
- K885277 — SPINAL ANESTHESIA TRAY
- K890070 — TOTAL BILIRUBIN REAGENT, CONCENTRATED
- K890675 — THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4
- K882401 — STONY BROOK MODEL EECP-MC1
- K882643 — AM TM SYRGICAL DRAPES
- K884025 — CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200
- K884103 — REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES
- K885045 — PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
- K885281 — VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
- K890189 — AGEN DIMERTEST EIA
- K890311 — KOSAN ANGEL LATEX SURGICAL GLOVES (STERILE)
- K890563 — SPQ(TM) ANTIBODY REAGENT SET II FOR TRF
- K890648 — MALIS BIPOLAR CORD/IRRIGATION TUBING SET
- K882585 — CAVROLAB
- K883848 — KMI OXY-BAN
- K884592 — ASTRO TRACE (MODEL AT-01)
- K884822 — MODEL OX-1 OXYGEN SATURATION MODULE
- K885317 — LYME ELISA TEST SYSTEM
- K890024 — SARNS VENT CATHETER
- K890199 — DENTOCULT SM-STRIP MUTANS
- K890299 — KONTRON PULSE OXIMETER 7840
- K890353 — SMDS460 SURGICAL MONITOR DISPLAY SYSTEM
- K890492 — PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.
- K890508 — WELLSHIRE EMLINK MODEL 1000
- K890723 — LANCER - MODULAR POWER BASE
- K871358 — SENSATIONS BRAND CONDOMS
- K882080 — MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.
Data sourced from openFDA. This site is unofficial and independent of the FDA.