FDA 510(k) clearances — page 850
clearances on record, most recent first.
Clearances — page 850
84,901–85,000 of 175,890- K993021 — METRX SYSTEM
- K993167 — MILLENNIUM INFANT VENTILATOR
- K993234 — MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
- K993385 — AUTOJET 2 (NON-FIXED NEEDLE TYPE)
- K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
- K993458 — POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
- K993488 — LIGHT-CORE
- K993583 — ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
- K993624 — SITE-RITE 3 ULTRASOUND SYSTEM
- K990457 — TED 60T OXYGEN ANALYZER
- K991880 — LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
- K991907 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
- K992136 — BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
- K992709 — 1818 TENS UNIT
- K992740 — EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS
- K992741 — LYPHOCHEK ANEMIA CONTROL, MODEL 500
- K992746 — SIGNA HFO/I MAGNETIC RESONANCE SYSTEM
- K992794 — STINGRAY DR, MODEL 1
- K992836 — SL990, SL980, SL950
- K992875 — SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
- K992879 — ECUSIT COMPOSITE REPAIR
- K992886 — POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A
- K992997 — OSTEOMARK NTX POC
- K993022 — SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS
- K993050 — OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
- K993161 — COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
- K993174 — SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
- K993219 — WAKO BILIRUBIN CALIBRATOR
- K993281 — K-ASSAY IGG
- K993324 — CARBOCEM ZINC POLYCARBOXYLATE CEMENT
- K993453 — MENISCUS ARROW, MODELS 531110, 531113, 531116
- K993466 — WAKO L-TYPE TRIGLYCERIDE TEST
- K993469 — WAKO L-TYPE UA F TEST
- K993712 — BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
- K991326 — ISOBAR SEMI-RIGID SPINAL SYSTEM
- K991662 — TITANIUM HARTSHILL SYSTEM
- K992621 — ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES
- K992674 — HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A
- K992702 — EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM
- K992738 — ISOBAR SPINAL SYSTEM
- K992961 — LORENZ SMALL FRAGMENT SYSTEM
- K992970 — DIGIT WIDGET
- K993141 — AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
- K993146 — DORNIER SCANNER HANDPIECE
- K993242 — CASTLE SURGICAL LIGHT, MODEL 3000
- K993516 — HP M2600A VIRIDIA TELEMETRY SYSTEM
- K990103 — MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL VENOUS RESERVOIR , CVR 600 AND 1200 SOFTSHE
- K990546 — DELSONIC 2000
- K991344 — WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS
- K991486 — ULTRA-CBX
- K992373 — ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
- K992654 — PLUG 'N VIEW 3D, VERSION 1.0
- K992656 — DEPUY TOTAL ELBOW SYSTEM
- K992660 — URF DIGITAL - OT
- K992752 — SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5
- K992797 — SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
- K992817 — ANTIBACTERIAL ADHESIVE BANDAGE
- K992924 — QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED
- K992999 — DAISY PROTECTED SCALP VEIN SET
- K993032 — MODIFICATION TO MP-3 POWER BASE CHAIR
- K993187 — SHELLY PROTECTED AV FISTULA NEEDLE
- K993221 — INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED
- K993222 — INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE
- K993247 — NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
- K993300 — COLDLIGHTSOURCE PL3000
- K993325 — INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE
- K993364 — GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION
- K993365 — GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION
- K993394 — ECHO SCAN, EASY SCAN
- K993398 — ECHO VIEW, EASY VIEW, OMNI VIEW
- K993459 — MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
- K984631 — BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
- K990229 — HPA PORTABLE KIDNEY PRESERVATION SYSTEM, MODEL J-1000-1
- K992853 — PASCO MIC AND MIC/ID PANELS, CEFDINIR
- K993536 — BIO-RAD CODA NEONATAL GALT ASSAY
- K990683 — AXON MP-1 MICROPOSITIONER
- K991054 — BRAVO MULTI-MODALITY SYSTEM
- K991617 — FACE-2-FACE CPR PROTECTION SHIELD
- K991672 — OLYMPUS NA-10J-KB ASPIRATION NEEDLE
- K991722 — DEVILBISS 5 LITER OXYGEN CONCENTRATOR
- K991884 — SIEMENS FIO2 SENSOR
- K992637 — MUSE CARDIOVASCULAR INFORMATION SYSTEM
- K992726 — PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS ORGANISMS
- K993186 — SYNERCID, 15 UG, BBL SENSI-DISC
- K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
- K990788 — AD-TECH'S FORAMEN OVALE ELECTRODE
- K991015 — LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT)
- K991241 — IF8000
- K991592 — KSEA DE LA PLAZA BLEPHAROPLASTY SET
- K991829 — CDTOX A OIA
- K991954 — THE BRUNO POWERBASE, MODEL PSB-2200
- K991975 — SERAQUEST EB NA IGG
- K992001 — TRAY-LINK
- K992310 — TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.
- K992492 — PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM
- K992623 — MITEK MINI ANCHOR
- K992717 — PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN
- K992843 — THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F
- K992884 — WHEELCHAIR (MANUAL, NOT ELECTRICAL)
- K992891 — SYNTHES CERCLAGE POSITIONING PIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.