FDA 510(k) clearances — page 866
clearances on record, most recent first.
Clearances — page 866
86,501–86,600 of 175,890- K984600 — METRA PS PROCEDURE KIT
- K990431 — AIA-PACK CA 125
- K990469 — LAMITRODE LEADS
- K990483 — RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
- K990668 — POWDER FREE BLUE NITRILE GLOVE
- K990728 — THERMAL CAUTERY DEVICE, FORCEPS
- K990778 — INSIGHT MILLENNIUM
- K990815 — COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS
- K990889 — AUTODOSE INFUSION SYSTEM
- K990910 — MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS
- K990911 — MTP ARTHROPUMP DISPOSABLE TUBING SET
- K990958 — ORTHOGONAL EP CATHETERS
- K991069 — KSEA NEURO-FIBERSCOPE
- K991167 — STERIS SMOKE EVACUATION SYSTEM
- K991442 — LC MICROFILL
- K991482 — UNI-CLIP STAPLE
- K991511 — POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
- K991538 — OPERA CUPFLANGED ACETABULAR COMPONENTS
- K991578 — SMARTSPOT 2000
- K991680 — SOFTINJECT
- K991710 — SSA-370A/POWERVISION 6000
- K982646 — AILEE SUTURES AND AILEE NEEDLES
- K990221 — INTRACOIL PERIPHERAL STENT
- K990658 — THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
- K990717 — FIXION INTRAMEDULLARY NAILING SYSTEM
- K990922 — OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR
- K991236 — GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER,
- K991311 — TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
- K991432 — BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
- K991552 — SYNTHES PEDIATRIC ROD SYSTEM
- K981353 — AVOGEL
- K982889 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
- K984290 — IMPLEX RADIAL HEAD REPLACEMENT SYSTEM
- K984468 — VITAL PEP
- K990154 — KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
- K990321 — ALPHAMED GEMINI SENSOR, SNORING SENSOR
- K990351 — BONE SCREWS
- K990353 — STAINLESS STEEL FIXATION PINS
- K990850 — COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
- K990943 — VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK
- K991051 — KSEA EPIDUROSCOPE
- K991101 — COAG-A-MATE MAX
- K991123 — PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM
- K991181 — MODIFICATION OF N PROTEIN STANDARD SL
- K991226 — FOUNDATION POROUS HIP STEM
- K991227 — 8MM FORGED CEMENTED STEM
- K991302 — SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS
- K991372 — CRP
- K991641 — AT HOME COCAINE & THC SCREENING TEST, MODEL 9170
- K991688 — WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S
- K991707 — MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206
- K991813 — UNI-GRAFT K DV VASCULAR GRAFT
- K974342 — ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
- K984141 — GBACT + KIT
- K990247 — MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470
- K990488 — SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE
- K990734 — DPD-12PCC
- K990736 — GC RELINE SOFT/EXTRA SOFT
- K990844 — STARDENTAL AXCS STERILE WATER SYSTEM
- K991088 — VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE
- K991156 — GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM
- K991158 — LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL, SMALL,MEDIUM,LARGE,EXTRA LARGE
- K991175 — MODIFICATION TO ALCYON DIRECT BILIRUBIN
- K991299 — MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
- K991430 — SMARTPREP CENTRIFUGE SYSTEM
- K991462 — QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED
- K991515 — INSURE PREGNANCY TEST
- K991528 — MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
- K991612 — STERISHARP 2.5-GALLON RSDC, MODEL #RSDC2.5G
- K991640 — HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES
- K991648 — REUSABLE CONTOUR II NASAL MASK
- K991661 — SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
- K983551 — CRIT-SCAN II MONITOR
- K983604 — INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER
- K984614 — NORMAL SALINE FLUSH SYRINGE
- K990015 — ELECTRODE NEEDLES
- K990432 — SURGISORB
- K990663 — INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150
- K990721 — ISOLOCK SPINAL SYSTEM
- K990753 — GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
- K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING
- K990891 — DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING
- K990902 — MODIFICATION OF MLT R694 RUBY LASER SYSTEM
- K990908 — MILLENNIUM
- K990968 — E-SCAN
- K991527 — CHROMOPHARE D500, D530, D650
- K991635 — MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
- K991703 — STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
- K981246 — BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
- K983805 — THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
- K984120 — THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
- K984135 — THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K984169 — DIGI-SNAP
- K984497 — TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201
- K990739 — QUANTEC-E ENDO SYSTEM
- K990963 — RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
- K991415 — SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
- K991431 — 14 FR. HEMODIALYSIS TWO-LUMEN CATHETERIZATION KIT
- K991493 — BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
- K991673 — CORDIS TEMPO ANGIOGRAPHY CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.