FDA 510(k) clearances — page 546
clearances on record, most recent first.
Clearances — page 546
54,501–54,600 of 176,542- K082937 — LIFEPAK 15 MONITOR/DEFIBRILLATOR
- K083185 — CADI SMARTSENSE VITAL SIGNS AND WIRELESS TEMPERATURE MONITORI NG SYSTEM, MODEL S1
- K083314 — IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
- K083570 — U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM
- K083625 — AERO DV TRACHEOBRONCHIAL STENT SYSTEM
- K083726 — PEDINAIL INTRAMEDULLARY NAILING SYSTEM
- K083738 — HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05
- K083762 — BIOLOX DELTA CERAMIC FEMORAL HEADS
- K083906 — ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487
- K090100 — SOFTSEAL-STF
- K090124 — GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814
- K090279 — SEDECAL, MILLENNIUM PLUS
- K090313 — PIGALILEO TKR BASE V2.3 AND CAS V4.1
- K090325 — JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
- K090374 — STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S
- K082899 — DYNAMIPEAK PEAK FLOW METER
- K083015 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K083206 — LOUSEBUSTER
- K083532 — ADX4000-L, DX3000-L
- K083677 — PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1
- K083749 — CARDIOVIEW32 REVIEW MODULE
- K090395 — FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E
- K090502 — NOVA SAFE SCALP VEIN BLOOD COLLECTION SET
- K090503 — ZQUIET MOUTHPIECE
- K081081 — ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
- K082478 — WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
- K082964 — PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)
- K083325 — N-600X WITH SPD, OXIMAX N-600X
- K083339 — DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
- K083412 — PATHFAST HSCRP
- K083649 — CARDIUS 3 X-ACT
- K083796 — MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
- K090349 — CLEARVUE PRONE BREAST TREATMENT TABLE
- K090419 — SILS STITCH ENDOSCOPIC SUTURING DEVICE
- K081063 — SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
- K081330 — CAREVENT PAR (PUBLIC ACCESS RESUSCITATOR)
- K082528 — SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM
- K082614 — EVOX ELECTRO DIAGNOSTIC DEVICE
- K082924 — DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER
- K083218 — TC ENDO PORT
- K083320 — DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE
- K083543 — DENOVISMED DENTAL IMPLANT SYSTEMS
- K083558 — MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C
- K083609 — KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE
- K083619 — PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020
- K083620 — SOMNOLYZER 24X7
- K083642 — DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
- K083694 — SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
- K083908 — BLACK NITRILE EXAMINATION GLOVES
- K090073 — D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
- K090075 — PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258
- K090084 — ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE
- K090230 — EXPEDIUM SPINE SYSTEM
- K081266 — MERCURY MEDICAL PEEP VALVE
- K083079 — QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100
- K083650 — EMU-GRAPH 4 EMULATOR, MODEL CI 144
- K083702 — TRACH-ASSIST
- K083755 — NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS
- K083776 — CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S
- K090001 — V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
- K090233 — GE DATEX-OHMEDA AISYS
- K090501 — BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1
- K090504 — CSBP-001A BODY PERFUSION SYSTEM
- K080611 — MESA SPINAL SYSTEM
- K081984 — LABORPRO SYSTEM
- K082487 — M-50 SERIES SPO2 SENSOR
- K083005 — NANGEL
- K083081 — MODIFICATION TO SECURACATH, MODEL: SPK01
- K083122 — HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
- K083182 — DATACOM DC PACS
- K083192 — INCLUSIVE TITANIUM ABUTMENT BLANKS
- K083311 — AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
- K083357 — OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
- K083451 — PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS
- K083573 — SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES
- K083607 — APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM
- K083612 — APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM
- K083791 — CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S
- K090248 — BIPAP AUTOSV
- K090252 — MODIFICATION TO: LANX SPINAL FIXATION SYSTEM
- K090281 — ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES
- K090295 — BODYVIZ, MODEL 100
- K090348 — CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
- K083471 — GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
- K083511 — ENVIRO SHARP SOLUTIONS 3
- K083566 — R3 CONSTRAINED LINER, CONSTRAINED LINER
- K083788 — ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR
- K090274 — MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
- K081851 — NEOSS ACCESS ABUTMENTS
- K082074 — ATRICURE CRYO1 CRYO-ABLATION PROBE
- K083233 — THE PFT FILTER
- K083414 — RADIONICS XKNIFE HDRT SYSTEM
- K083456 — NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
- K083596 — REEKROSS FAMILY OR OTW PTA CATHETERS
- K083636 — REPROCESSED EXTERNAL FIXATION DEVICE
- K083766 — PHOGLASS CEM
- K081240 — TIGER DISCECTOMY DEVICE
- K082328 — GLUCODR PLUS SYSTEM, MODEL AGM-3000
- K082682 — SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
- K082771 — PROTRON TECHNOLOGIES, LLC STETHOTRON
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