FDA 510(k) clearances — page 843
clearances on record, most recent first.
Clearances — page 843
84,201–84,300 of 175,890- K992448 — V.A.C. PLUS
- K992563 — A-22 HEMODIALYZER
- K992564 — AF-180 HEMODIALYZER
- K992566 — AF-150 HEMODIALYZER
- K992573 — AF-220 HEMODIALYZER
- K992658 — OSOM ULTRA STREP A TEST, MODEL 147
- K992727 — THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM
- K992811 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
- K992901 — GYNECARE VERSAPOINT G-VAP ELECTRODE
- K993239 — STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX
- K993574 — OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON
- K993599 — DIAGNOSTIC PRO, MODEL 12772, VXR-16, MODEL 13020, VXR-16 DOSIMETRY PRO, MODEL 13019
- K993614 — FAS ENDOLUMINAL BRUSH
- K993658 — RENAMEL SCULPT
- K993659 — RENAMEL PACK
- K993720 — CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER
- K993802 — SHARPVIEW IMAGE ENHANCEMENT SYSTEM
- K993813 — LUMAGEM SCINTILLATION CAMERA
- K993847 — TEH LOONG, VINYL, POWDERED, PATIENT EXAMINATION GLOVES
- K993849 — TEH LOONG VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVE
- K993870 — UNSCENTED INTERLABIAL MENSTRUAL PAD
- K993920 — ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17
- K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
- K993942 — LITESABER 2000
- K993984 — SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL
- K994040 — PHASED ARRAY KNEE AND FOOT COIL
- K994071 — RHIGENE ANA ELISA TEST SYSTEM
- K994081 — SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES
- K994095 — LATEX CONDOM
- K994132 — HARDYDISK IMIPENEM, 10MCG
- K994200 — ACCESS HYBRITECH PSA QC, MODEL 37209
- K994330 — ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076
- K994333 — ORA-50 ELECTROTHERMAL SYSTEM AND ACCESSORIES
- K994427 — CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL
- K994437 — CYNOSURE PHOTOGENICA SPIR
- K983953 — MICROSTREP PLUS PANEL, VANCOMYCIN
- K984551 — INFRARED EAR THERMOMETER, MODEL KI-8120
- K991916 — VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
- K992007 — PHARMASEED, MODEL BT-103-1
- K992684 — FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
- K992749 — ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
- K992785 — IBC FLOGUARD, MODEL 6050
- K992851 — ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
- K993238 — FORTOSS-CEMA
- K993519 — RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
- K993679 — MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN
- K993924 — WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
- K993927 — WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
- K994063 — HARDYDISK AZTREONAM, 30MCG
- K994067 — HARDY DISK AMPICILLIN/SULBACTAM
- K994073 — HEMOSITE TEST SYSTEM
- K994277 — ACCESS OSTASE QC
- K994316 — MAGNETOM OPEN VIVA WITH PERMANENT MAGNET
- K994388 — XE CHECK
- K994439 — ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
- K990987 — BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B
- K991862 — MICOMED POSTERIOR DOUBLEROD SYSTEM (MPDS)
- K992053 — AESCULAP VASCULAR INSTRUMENTS
- K992434 — ITP, MODEL 1.0
- K992454 — VENAFLOW SYSTEM, MODEL 30A
- K992584 — PE 501 PC-ECG MONITOR
- K992729 — NIPRO LUER ADAPTOR
- K992779 — A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM
- K993377 — MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)
- K993531 — PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
- K993550 — AVIVA SYSTEM, MODEL SL1010
- K993551 — SOCON SPINAL SYSTEM
- K993657 — ACUMED SUTURE ANCHOR
- K993963 — SIGMA MANUAL WHEELCHAIR
- K994048 — PORTABLE LIGHT CURING UNIT
- K994072 — AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM
- K994107 — AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.
- K994185 — MANUAL WHEELCHAIR
- K994208 — AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
- K994241 — TRX-CG POWER TILT AND RECLINE SYSTEM
- K994313 — MODIFICATION TO BONE ANCHOR AND KIT (BAK)
- K994358 — ATW MARKER WIRE STEERABLE GUIDEWIRE
- K991087 — HANNAH WIRELESS VITAL SIGNS MONITOR
- K992116 — SIEMEMNS INFINITY ETC02 POD
- K992258 — HOT SHOT FLUID WARMER IV FLUIDS
- K992396 — BIORCI SCREW
- K992719 — AMSURE ENTERAL DELIVERY PUMP SET WITH SPIKE
- K992941 — LEMAITRE BILIARY CATHETER
- K993472 — SEGMENTED VAGINAL APPLICATOR
- K993567 — INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]
- K993793 — GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE
- K993795 — CONVERTORS SURGICAL DRAPES
- K993839 — ENA PROFILE ELISA TEST SYSTEM
- K993859 — SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
- K993880 — SHANGHAI GLOVMAX ENTERPRISE CO, LTD., POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K994028 — FLIPO XENON CURING LIGHT
- K994056 — ADMIRA
- K994325 — SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
- DEN000001 — OHMEDA INOVENT DELIVERY SYSTEM
- K971732 — DENTAL HANDPIECE
- K990856 — HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682
- K992256 — FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01
- K992489 — 3M TR SYSTEM
- K992916 — BRAINLAB STEREOTACTIC ARC
- K992959 — BEHRING COAGULATION SYSTEM (BCS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.