FDA 510(k) clearances — page 743
clearances on record, most recent first.
Clearances — page 743
74,201–74,300 of 175,825- K014218 — OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210'
- K020003 — ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE
- K020888 — FUNDUS AUTOIMAGER
- K021434 — ARTHREX FIBERWIRE IN USP SIZES
- K022159 — PISTON SYRINGE & HYPODERMIC NEEDLE
- K022655 — TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH
- K022675 — PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
- K023039 — BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015
- K023048 — MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
- K023417 — SURETAC III, MODELS 7209900, 7209901
- K023458 — TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML)
- K023557 — CENTRICITY PACS PLUS
- K023631 — ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS
- K022634 — CO-AXIAL INTRODUCER NEEDLE
- K022644 — RETRO REPAIR KIT, MODEL PRRK5
- K022674 — BIRD AVEA VENTILATOR
- K022954 — AMEDICA DRUG SCREEN COCAINE TEST
- K022955 — AMEDICA DRUG SCREEN THC TEST
- K023047 — AMEDICA DRUG SCREEN OPIATES TEST
- K023344 — INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE
- K023350 — ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
- K023357 — ARCPM 1050 RESIN-HIPS
- K023402 — 8F LAUNCHER GUIDE CATHETER
- K023418 — HEARTONE EVENT RECORDER AND TRANSMITTER
- K023425 — DRAPES WITH ABSORBENT REINFORCEMENT
- K023697 — STERI-MATE STERILIZABLE HANDPIECE
- K020920 — COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE
- K021402 — THERMAGE THERMACOOL TC SYSTEM
- K022036 — SIEMENS VIRTUAL SIMULATION (VSIM)
- K022610 — CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160
- K022629 — WMT-TCP BONE GRAFT SUBSTITUTE
- K022643 — BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540
- K022645 — CURAD
- K022682 — RANDOX C-REACTIVE PROTEIN CALIBRATOR
- K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST
- K023106 — PROMOTOR
- K023197 — CERANUM 82
- K023442 — EXTRA LARGE BODY COIL
- K023511 — EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2
- K023586 — DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
- K021467 — AUTOCON II 400 ELECTROSURGICAL GENERATOR
- K021576 — MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370
- K021732 — DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT
- K022007 — LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
- K022047 — PHLEBOTEST 2000
- K022751 — REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS
- K022931 — HYALURONIDASE SOLUTION
- K022948 — VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
- K023199 — CERANUM 50
- K023200 — CERANUM 76
- K023298 — HEMCON BANDAGE
- K023432 — MEDLINE ASEP PLUS SURGICAL DRAPES
- K023497 — DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE
- K023569 — SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS
- K023616 — PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
- K011005 — PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS
- K020540 — REGENECARE WOUND GEL
- K020886 — PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US
- K021551 — STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
- K022012 — SYNTHES LOW PROFILE NEURO SYSTEM
- K022021 — VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
- K022593 — THOMAS MEDICAL ELECTRODES
- K022594 — PLAYTEX BREAST PUMP
- K022597 — K-FIX
- K022680 — AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK)
- K022681 — AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)
- K022835 — STEPHENS DISPOSABLE FORCEPS
- K022836 — STEPHENS DISPOSABLE SPECULUM
- K022840 — STEPHENS DISPOSABLE SCISSORS
- K022842 — STEPHENS DISPOSABLE HOOKS
- K022843 — GAYHEART CORNEAL EXCISION DEVICE
- K022962 — WIENER LAB. BILIRRUBINA TOTAL AA
- K023196 — LUCIUS 76
- K023198 — CERANUM 90
- K023309 — CONTROL PLASMA N
- K023312 — CONTROL PLASMA P
- K023457 — ULTRASOUND SCANNER, TYPE 1101
- K023538 — TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER
- K020689 — SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM
- K020749 — DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS
- K020750 — DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS
- K021056 — PERMACOL
- K022570 — MEDCOMP REPAIR KIT, MODEL ASPCRPK
- K022583 — FLASH 1
- K022638 — NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
- K022663 — KERADEC
- K023273 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML
- K023307 — MAS DIABETES CONTROL - LYOPHILIZED ASSAYED DIABETES CONTROL
- K023447 — MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)
- K023486 — OSSTAPLE, MAXILLOFACIAL
- K023488 — OSSTAPLE, CRANIOFACIAL
- K023495 — WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)
- K010401 — TRI-PLEX ADAPTER
- K022060 — LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES
- K022536 — \RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
- K022599 — NEWDEAL K WIRE
- K023079 — NEW OUTLINE
- K023440 — PHILIPS DIGITAL IMAGING OPTION RELEASE 1
- K023441 — PHILIPS MULTIDIAGNOST ELEVA
- K020641 — SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001
Data sourced from openFDA. This site is unofficial and independent of the FDA.