FDA 510(k) clearances — page 818
clearances on record, most recent first.
Clearances — page 818
81,701–81,800 of 176,637- K003305 — PEDIATRIC INGESTASCAN
- K003366 — MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL
- K003635 — DW 276 #3
- K003685 — MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL
- K003687 — VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC
- K003769 — ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES, MODEL 87
- K003790 — DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
- K003849 — GE ADVANCE NXI PET SYSTEM
- K994279 — PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
- K000714 — VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SET
- K001634 — CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
- K002122 — VECTOR
- K002425 — MEDIADENT HDX/MMD HDX SP XRAY SENSOR
- K002954 — RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS
- K002955 — EMPIRE N BLOOD PRESSURE MANOMETERS
- K003192 — MAGNETIC CONCERTO
- K003243 — SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC 9000XL
- K003246 — SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
- K003248 — SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
- K003264 — QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
- K003277 — SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33
- K003337 — HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
- K003371 — PUMP TUBING WITH X-COATING
- K003545 — NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE
- K003547 — NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
- K003598 — DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320
- K003623 — INTERACTIVE REAL TIME SCANNING PACKAGE
- K003634 — DW 272 #1
- K003681 — BIO-LOGIC SLEEPSCAN NETLINK
- K003724 — CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
- K003734 — SERUM PROTEIN SUBSTITUTE
- K984579 — CAPNO PROBE A
- K991093 — MSD EMBOLECTOMY BASKET
- K001763 — CRIT-LINE MONITOR III (CLM III)
- K002308 — OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A
- K002550 — RDH BANDAGE
- K002854 — GOLD CORE POST SOLDER
- K002925 — COOLBLU CURING LIGHT
- K003100 — WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM
- K003118 — Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
- K003564 — HAKIM PROGRAMMER AND TRANSMITTER
- K003565 — HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
- K003621 — ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0
- K003624 — REFINITY SYSTEM, REFINITY HANDPIECE AND CABLE, REFINITY FOOTSWITCH, REFINITY POWER CORD, MODEL V5100-00,V5701-00,V5702
- K003632 — DW 273 #1
- K003633 — DW 277 #4
- K003642 — PLACEMENT-PLUS
- K003716 — CONFORMANCE CHEMISTRY CONTROL C3
- K003728 — MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
- K003730 — CHEMO-AIDE DISPENSING PIN
- K003772 — ELECSYS DHEA-S CALCHECK
- K003781 — COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
- K000081 — MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM
- K002156 — APPRAISE URINE MICROALBUMIN COLLECTION KIT
- K002393 — NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM
- K002738 — BAYER RAPIDPOINT 400 SYSTEM
- K002815 — GOLD CORE HF PRE SOLDER
- K002942 — PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING
- K002944 — PRECISA BIOPSY NEEDLE
- K002946 — SILENT BIOPSY NEEDLE
- K002947 — BIOMOL ASPIRATION BIOPSY NEEDLE
- K002964 — NEURO II
- K003115 — ACTIS ADJUSTABLE CONSTRICTION LOOP
- K003280 — VARIANT II TOTAL GHB
- K003569 — PLASMAKINETIC ENDOUROLOGY SYSTEM
- K001441 — SATURN BLOOD GLUCOSE MONITORING TEST STRIP
- K001927 — VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME
- K002920 — MEGAVISION CPX, MEGAVISION FA, MODEL I AND II
- K002923 — DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM
- K002984 — EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION
- K002999 — GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
- K003000 — GRAMS NYLON NONABSORBABLE SUTURE
- K003092 — MODIFICATION TO VNUS CLOSURE SYSTEM
- K003120 — MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
- K003158 — ROCHE DIAGNOSTICS CK-MB
- K003622 — M2376A DEVICELINK SYSTEM, MODEL M2376A
- K003721 — MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER
- K993406 — TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0
- K001282 — AIW WATER SYSTEM FOR HEMODIALYSIS
- K001491 — QUICKIE 2 POWER ASSIST WHEELCHAIR
- K002384 — M-XX OXYGEN SENSORS
- K002733 — SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
- K002747 — REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
- K002906 — ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07
- K002971 — MTG - MINITUB HEATED STAGE SYSTEMS
- K002972 — MEROGEL CONTROL GEL ENT SURGICAL DRESSING
- K003001 — GRAMS SILK NONABSORBABLE SUTURE
- K003015 — SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD
- K003018 — TITAN TIBIAL NAIL
- K003038 — AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A
- K003048 — ALL TERRAIN WHEELCHAIR (ATW)
- K003147 — LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
- K003161 — ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT
- K003170 — RYTHMIC AND RYTHMIC UV
- K003205 — TRANSFX ANGLED RODS
- K003211 — HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING
- K003363 — M2A 32MM TAPER SYSTEM
- K003439 — VIVANT BREAST LESION LOCALIZATION DEVICE
- K003447 — PROTRACT PRESS FIT HIP STEM
- K003656 — X-POSURE SYSTEM VERSION 2 MAMMO
Data sourced from openFDA. This site is unofficial and independent of the FDA.