FDA 510(k) clearances — page 833
clearances on record, most recent first.
Clearances — page 833
83,201–83,300 of 176,637- K001371 — CARDEON ASCENDING BALLOON CANNULA (ABC)
- K001494 — MODIFICATION TO PROMPT L-POP
- K001707 — DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
- K001778 — POROCOAT PRODIGY HIP PROSTHESIS
- K001822 — THE V-BAG
- K001910 — IM-9C MICROINJECTORS
- K001911 — IM-9A MICROINJECTORS
- K001912 — IM-9B MICROINJECTORS
- K994032 — FLUORO-TEX CARDIOVASCULAR PATCH
- K001129 — PROLONG, MODELS PL50, PL100, PL150
- K001334 — HITACHI AIRIS II
- K001596 — LIFERX
- K001756 — LUNAR REPORT GENERATOR II
- K001772 — LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
- K001789 — SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
- K001894 — MODIFICATION TO E-SCAN
- K993527 — LOOP ELECTRODE, BALL ELECTRODE
- K994265 — MEDISANA DIGITAL TENS
- K994266 — FDTENS 2010
- K000901 — KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
- K001110 — CRYSTAL-EEG MODEL 15
- K001117 — COMFORT STIM
- K001137 — AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)
- K001165 — POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K001218 — CORRECT PLUS
- K001337 — DANIELS SHARPSMART REUSABLE SHARPS CONTAINER
- K001383 — SUPREMCAST V
- K001418 — ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S
- K001430 — RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
- K001432 — DISPOSABLE PVC SYNTHETIC EXAM GLOVES, POWDER FREE
- K001469 — R&D PROJECT DW269#25
- K001518 — GRADIA
- K001715 — POWDERED PATIENT EXAMINATION GLOVES, LATEX
- K001758 — DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED)
- K001770 — BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A
- K001845 — MALLINCKRODT, GOODKNIGHT 418S
- K981089 — TISSOMAT AND SPRAY SET
- K983667 — IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE
- K994404 — INSTANT-VIEW MORPHINE URINE CASSETTE TEST
- K000586 — BIOSCANNER TRIGLYCERIDES TEST STRIPS
- K001135 — 6F & 7F INTRODUCING CATHETERS (MODIFICATION)
- K001235 — OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136
- K001848 — OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907
- K993741 — EZ LDL CHOLESTEROL TEST SYSTEM
- K000860 — FUTURA SAFETY SYRINGE
- K000952 — HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR
- K001059 — NORMOCARB STERILE BICARBONATE RENAL DIALYSIS
- K001069 — MODEL 4000 EEG MONITOR WITH PSI (PSA4000)
- K001081 — BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810
- K001095 — OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130
- K001101 — XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4
- K001103 — WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED)
- K001146 — GENYX FLEXIBLE INJECTION NEEEDLE
- K001322 — PERFORMER 30 HPS
- K001611 — DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
- K001664 — COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120
- K001670 — AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-757
- K001671 — ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630
- K001674 — POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
- K001682 — VSCORE WITH EKG SIGNAL GATING
- K001688 — DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
- K001722 — AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE
- K001776 — MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
- K001787 — QUART ARTERIAL FILTER, MODEL HBF 140
- K001801 — STEATHSTATION TREATMENT GUIDANCE PLATFORM
- K001834 — SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
- K001862 — SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES
- K001888 — UNICORN MODEL SYS0630
- K994130 — RECTOSIGHT RS 300-04
- K001031 — URANUS, COMFORTOUCH LASER SYSTEM
- K001080 — SPINE SYSTEM EVOLUTION
- K001150 — ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE
- K001227 — ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT
- K001417 — ONTRAK TESTCUP 502, MODEL 3016641
- K001443 — SUGAR CHEX ONE
- K001705 — STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF
- K992757 — CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER
- K993154 — LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM
- K993939 — NICOLET EME LEGEND TC22
- K001364 — BD DIRECTIGEN FLU A+B
- K001679 — VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3
- K001700 — XPLAN 2.1
- K001846 — ELECSYS INSULIN CALCHECK
- K994419 — FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
- K000565 — MODIFICATION TO NC-STAT
- K000619 — SCANDINAVIAN IVF SCIENCES AB, G2.2
- K000683 — MODIFIED SINGLE AXLE TOTAL ELBOW
- K000707 — LEICA COLPOSCOPE
- K001151 — ELECTROSURGICAL ELECTRODE FAMILY
- K001157 — MONARCH II IOL DELIVERY SYSTEM
- K001180 — TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528
- K001258 — BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
- K001305 — MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM
- K001382 — AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
- K001517 — SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES
- K000992 — MACROPOREDX DISTRACTOR SYSTEM
- K001226 — SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
- K001344 — ADVIA IMS
- K001569 — INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
- K000278 — VIVANT MEDICAL BIOPSY MARKER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.