FDA 510(k) clearances — page 676
clearances on record, most recent first.
Clearances — page 676
67,501–67,600 of 175,825- K042306 — PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A
- K042493 — ENSITE SYSTEM, MODEL EE3000
- K042568 — EXCELSIOR 1018 AND SL-10 MICROCATHETERS
- K042593 — ACUSON ACUNAV 8F ULTRASOUND CATHETER
- K042712 — TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
- K042771 — GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3
- K033421 — ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS
- K041155 — WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
- K041222 — PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
- K041525 — HEMOVAC BLOOD REINFUSION SYSTEM
- K041530 — EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001
- K041628 — AESKULISA DS DNA G
- K041662 — APNEA RISK EVALUATION SYSTEM (ARES)
- K041943 — XTRAC XL, MODEL AL8000
- K042063 — PRESS TACK NEEDLE
- K042336 — METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
- K042367 — NYLON THREADED NEEDLE
- K042405 — PAINPUMP1; PAINPUMP2
- K042502 — 3 SERIES PHOTOTHERAPY CABINET
- K042590 — TRANSDERM IONTO SYSTEM, MK 2
- K042667 — SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD)
- K040783 — FOUNDATION
- K041110 — MB 105 MILLENNIUM BLADES
- K042271 — NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES
- K042581 — AMLUCK, YA HORNG
- K042655 — INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456
- K042736 — CDX DIGITAL X-RAY IMAGING SYSTEM
- K042742 — HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)
- DEN040007 — VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
- K031728 — KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET
- K042173 — COULTER A T 5DIFF CAP PIERCE (CP)
- K042501 — ETG-4000 OPTICAL TOPOGRAPHY SYSTEM
- K042541 — MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
- K042561 — TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
- K042616 — BIOMEDIX PADNET LAB
- K042703 — CYBIRD LED CURING LIGHT
- K040563 — LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT)
- K041019 — THE FUGO BLADE FOR GLAUCOMA
- K041353 — FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
- K041874 — ABL800 FLEX
- K041877 — ACU-STRAP MOTION SICKNESS BAND
- K042396 — T2 PROXIMAL HUMERAL NAIL
- K042403 — MIRAGE SWIFT
- K042408 — IQQA-CHEST SOFTWARE PACKAGE
- K042410 — BAXJECT II
- K042416 — ATHENA MULTI-LYTE ANA-II TEST SYSTEM
- K042419 — FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
- K042437 — DORSAL INTRAMEDULLARY PLATE
- K042517 — BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS
- K042524 — MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
- K042554 — AUTO THERM 390, MODEL ME 390
- K042605 — COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
- K042634 — WIDE 1MP LCD MONITOR SYSTEM
- K042764 — MEDLINE STRIDER MIDI 4
- K041005 — GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS
- K041163 — ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
- K041430 — BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
- K041774 — IUR RECIPROCATING MORCELLATOR MODEL # 7210517
- K042001 — PANORAMIC 200A
- K042032 — MAESTRO TOTAL WRIST
- K042135 — SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION)
- K042143 — EXCELLA-M SPINAL SYSTEM
- K042172 — CLEO 90 INFUSION SET
- K042189 — DIAZYME SODIUM ENZYMATIC ASSAY
- K042201 — NOVEL VBR SPINAL SYSTEM
- K042324 — LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
- K042331 — PASCO MIC AND MIC/ID PANELS
- K042332 — TITANIUM TELEGRAPH HUMERAL NAIL
- K042356 — SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
- K042358 — LOCON VLS DISTAL RADIUS PLATE SYSTEM
- K042377 — SYNTHES LOW PROFILE RECONSTRUCTION PLATES
- K042401 — VARI-ABLE APB (ADAPTABLE POSITIONING BASE)
- K042436 — IIIZAROV PULLEY SYSTEM
- K042439 — AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM
- K042440 — ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM
- K042453 — MODIFICATION TO EQUATION FIXATION SYSTEM
- K042458 — A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
- K042498 — VERTEX RECONSTRUCTION SYSTEM
- K042499 — ORION ANTERIOR CERVICAL PLATING SYSTEM
- K042508 — SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM
- K042514 — MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
- K042647 — EXAM-PACS
- K042692 — CLARITY FUSION
- K042763 — MODIFICATION TO MEDLINE STRIDER MIDI 3
- K041598 — LASEREX, MODEL LP4532
- K041854 — MPM SYSTEM
- K041899 — VECTORVISION UNI-KNEE
- K041994 — MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
- K042060 — EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE
- K042156 — CARDEON COBRA CATHETER
- K042253 — SLEEPSENSE SLEEP SENSORS
- K042270 — STAT K IN VITRO DIAGNOSTIC TEST SYSTEM
- K042290 — VACUUM ASSISTED CORE BIOPSY DEVICE
- K042423 — VERIFYNOW-ASPIRIN ASSAY
- K042469 — BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER
- K042529 — BALANCEBACK VNG SYSTEM
- K042558 — EQUI-FLOW VALVE AND SHUNT SYSTEM
- K042560 — STELLAR 404 MONITORING SYSTEM
- K042609 — HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
- K042612 — JAZZY 600
Data sourced from openFDA. This site is unofficial and independent of the FDA.