FDA 510(k) clearances — page 552
clearances on record, most recent first.
Clearances — page 552
55,101–55,200 of 175,825- DEN070003 — NEUROSTAR TMS SYSTEM
- K081010 — BARD 3DMAX MESH
- K081666 — ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS
- K081935 — STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100
- K081952 — SYNERGY SPINAL SYSTEM (6.35 POLARIS)
- K082442 — MODIFICATION TO MICROFUSE BONE VOID FILLER
- K082608 — RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601
- K082618 — ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455
- K082784 — JUMAO MANUAL WHEELCHAIR
- K071969 — SEN-4100 ELECTRIC STIMULATOR
- K081478 — RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS
- K081820 — AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR
- K082032 — SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310)
- K082149 — LYMPHA PRESS OPTIMAL, MODEL# 1201AP
- K082217 — RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
- K082271 — FLUCONAZOLE 25UG BBL SENSI-DISC
- K082301 — GRIND NO MORE
- K082661 — BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
- K082663 — COLOR LCD MONITOR
- K082664 — JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100
- K080786 — ML830TP
- K080825 — IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
- K081799 — GORE TRI-LOBE BALLOON CATHETER
- K081842 — ENGSTROM CARESTATION, ENGSTROM PRO
- K081933 — AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR
- K082069 — PASS 2 SPINAL SYSTEM
- K082515 — ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX
- K082544 — QUART ARTERIAL FILTER WITH BIOLINE COATING
- K082567 — STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
- K082577 — PASS LP SPINAL SYSTEM
- K082633 — INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90
- K073700 — 6F PROXIS SYSTEM
- K080052 — STRYKER ESSX WITH NAVIGATION MOUNT
- K080901 — LBI EMBOLECTOMY SYSTEM
- K081545 — ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
- K081611 — NUVASIVE COROENT SYSTEM
- K081880 — ATLAS SPINE SPACER
- K081995 — STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV)
- K082058 — DYNAMATRIX
- K082071 — ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT
- K082106 — ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
- K082109 — BOVIE ICON GENERAL PURPOSE RF GENERATOR
- K082272 — VORICONAZOLE 1UG BBL SENSI-DISC
- K082461 — BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
- K082520 — SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
- K082587 — AUTO-SAFETY INJECTOR-2 (ASI-2)
- K073000 — LUMAPROBE
- K073022 — CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830
- K081572 — SMARTSIGNS MINPULSE
- K081893 — OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
- K082238 — NEOMED POLYURETHANE FEEDING TUBE
- K082331 — MAGNETOM C!
- K082510 — IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0
- K082707 — MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER
- K082757 — MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM
- K082764 — STRAUMANN WN CARES TITANIUM ABUTMENT
- K080570 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL
- K081425 — COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT
- K081448 — ENCORE SHOULDER REVISION GLENOID
- K081658 — POWDER-FREE VINYL EXAMINATION GLOVES
- K081749 — AVANTE Z ZIRCONIA (AS)3 BLOCKS
- K081782 — COLLIEVA
- K082047 — SECURACATH CATHETER, MODEL SPK01
- K082159 — CIVASTRING PD-103
- K082364 — IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR
- K082444 — DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED
- K082562 — APPLIED BIOSYSTEMS 7500 FAST DX
- K082571 — AVAULTA SUPPORT SYSTEM
- K082656 — MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT
- K081553 — AED BIPOLAR FORCEPS, MODEL 13-1646
- K081777 — VENTRIO HERNIA PATCH
- K081865 — PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
- K081871 — UNIVERSAL ELECTRODES
- K082140 — XPERT MRSA/SA BLOOD CULTURE ASSAY
- K082752 — QUICKPIN
- K080017 — VIDAS AFP ASSAY
- K080700 — DUOFLO CATHETER
- K080933 — HANDHELD ECG MONITOR, MODEL MD100
- K080948 — HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH
- K081231 — ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33
- K081539 — DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
- K081625 — FLOWPICC STYLET
- K081808 — ACUNAV V ULTRASOUND CATHETER
- K081860 — ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS
- K081987 — UNISYN IMAGE FUSION, VERSION 1.0
- K081989 — MODIFICATION TO FETCH ASPIRATION CATHETER
- K082004 — SMOOTHKIT+
- K082029 — SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE
- K082037 — SEEPLATE CERVICAL PLATE SYSTEM
- K082167 — PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX
- K082256 — LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE
- K082317 — GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION
- K082366 — LIFEBED PATIENT VIGILANCE SYSTEM
- K082443 — DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE
- K082469 — UNITED U2 PATELLA
- K082519 — FINECROSS MG CORONARY MICRO-GUIDE CATHETER
- K082523 — OSSTELL ISQ IMPLANT STABILITY METER
- K082524 — MINI GHOST, MODEL: 507
- K082616 — HASELMEIER PEN 8
- K082685 — GALAXY 55
Data sourced from openFDA. This site is unofficial and independent of the FDA.