FDA 510(k) clearances — page 591
clearances on record, most recent first.
Clearances — page 591
59,001–59,100 of 175,825- K071025 — ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO
- K071064 — ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA
- K071178 — OTOMEDICS SOFT TYMPANOSTOMY TUBE
- K071184 — SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM
- K071192 — BLUGOO HD
- K071297 — IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)
- K071323 — POWDERED LATEX EXAMINATION GLOVES
- K071401 — X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
- K062372 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
- K063605 — ST AIA-PACK INTACT PTH ASSAY
- K070159 — PRELUDE SHEATH INTRODUCER
- K070491 — DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200
- K070533 — BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS
- K070596 — TOPICAL APPLICATOR
- K070610 — SKATER BILIARY CATHETER
- K070660 — INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
- K070841 — ENDOSSEOUS DENTAL IMPLANT SYSTEM
- K070924 — FLEXGUARD
- K070941 — CLEVER CHEK HEALTH CARE SYSTEM SOFTWARE, VERSION 1.0
- K070975 — SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES
- K071002 — IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT
- K071430 — SYNERAD OMNI, MODELS AN6255 AND AN6265
- K062558 — MESOSFOL SURGICAL FILM
- K063282 — CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET
- K063753 — GFX NERVE ABLATION SYSTEM
- K063818 — QUANTA PLEX CELIAC IGA PROFILE
- K070490 — CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)
- K070666 — GENESISCS COMPONENT CONCENTRATING SYSTEM
- K070815 — THD
- K070917 — FEEL-JECT INSULIN SYRINGE
- K071169 — CLEARFIL MAJESTY POSTERIOR PLT
- K071180 — SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
- K071195 — KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5
- K071232 — IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS
- K071233 — XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM
- K071399 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100
- K071425 — UNITE BIOMATRIX
- K063232 — ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
- K062613 — BIS EEG MONITOR VIEW
- K070288 — CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814
- K071020 — DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE
- K071125 — AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016
- K070263 — APNEALINK
- K070639 — NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING
- K070656 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K070869 — PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422
- K070901 — MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
- K071387 — FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB
- K063876 — MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
- K070336 — STOCKERT NEURO N50, MODEL12267
- K070444 — AOS TIBIAL NAIL
- K070449 — LUMILOC (TM) SAFETY INTRODUCER NEEDLE
- K070617 — CANNULATED SCREW
- K071218 — PROXENON 350, MODEL 902XX
- DEN060002 — INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM
- DEN070006 — BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX
- K062883 — GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
- K062885 — STRIDE MICROCATHETER
- K070198 — ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02
- K070255 — NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
- K070403 — PRONTO .035 EXTRACTION CATHETER
- K070580 — NASOPHARYNGOSCOPE, BRONCHOSCOPE
- K070853 — DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022
- K070933 — LOWTOP PEDICLE SCREW SYSTEM
- K071042 — POLARCATH PERIPHERAL DILATATION SYSTEM
- K071179 — NORAS OR HEAD HOLDER
- K071203 — SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES
- K071376 — MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
- K071378 — MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
- K071408 — X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR
- K071426 — MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE PATIENT MONITORS
- K071458 — MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
- K052936 — THERMAGE THERMACOOL SYSTEM
- K061438 — ULTRAEZ DESENSITIZING GEL
- K062737 — CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
- K071069 — MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY
- K063106 — REVOIS IMPLANT SYSTEM
- K063407 — BC-3200 AUTO HEMATOLOGY ANALYZER
- K063498 — HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)
- K070281 — ISSYS LP SPINAL FIXATION SYSTEM
- K070425 — VITALSTIM EXPERIA
- K070453 — OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
- K070460 — ALLEZ SPINE CROSS CONNECTORS
- K070560 — LRTM SURGICAL MESH
- K070891 — ALTIVA CLASSIC ACP SYSTEM
- K071153 — GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
- K071372 — MODIFICATION TO: INTERPLATE VBR SYSTEM
- K071403 — X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM
- K062484 — FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
- K062704 — STERILIZATION POUCH WITH INDICATORS
- K070380 — PORTACLAMP FLEX
- K070573 — SYNAPSE SYSTEM
- K070654 — HYPERTHERMIA PUMP
- K070810 — ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F)
- K071047 — MASIMO PATIENT SAFETY NET
- K071241 — LMS-LIVER
- K071310 — SYNGO CT ONCOLOGY SOFTWARE PACKAGE
- K071360 — OPTICAL GUIDANCE PLATFORM
- K071402 — X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM
- K071409 — X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.