FDA 510(k) clearances — page 411
clearances on record, most recent first.
Clearances — page 411
41,001–41,100 of 175,770- K131027 — MEMORY PUMP MODEL Y4947
- K131199 — ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
- K131216 — RAMPART O
- K131404 — FLASH AR PENTA / FLASH AR PENTA QUICK
- K123041 — VASOSTAT HEMOSTASIS DEVICE
- K124056 — FREND PSA PLUS (REAGENT CARTRIDGE)
- K130170 — EXSPIRON 1XI
- K130278 — MR PERMEABILITY
- K130288 — STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE
- K130297 — SCANORA 3DX
- K130354 — MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR)
- K130411 — 740 SELECT
- K131045 — ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
- K131121 — FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
- K131225 — ADROIT GUIDING CATHETER
- K131295 — NIO COLOR 3MP LED
- K131392 — ETIAM PACS COMPONENTS
- K123034 — VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED
- K123801 — FINGER PULSE OXIMETER
- K130343 — CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS
- K121065 — POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
- K121898 — STAY FRESH SKIN FOLD MANAGEMENT TEXTILE
- K122639 — SYNTHES SYNCAGE EVOLUTION SPACER
- K122801 — PROVIDENCE CERVICAL CAGE
- K123569 — ANTEGRADE FEMORAL NAIL
- K123619 — INTRABLOCK BIOBALL HIP SYSTEM (IBS)
- K123692 — PIPELINE KNEE SYSTEM
- K123746 — AMES THERAPY DEVICE
- K123855 — WATER-FILLED TEETHER
- K123925 — MTM CLEAR ALIGNER IN-OFFICE
- K130184 — ZENOLUX
- K130481 — SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK
- K130559 — MOBICATH BI-DIRECTIONAL GUIDING SHEATH
- K130634 — CORIN METAFIX HIP STEM
- K130911 — RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
- K130917 — HEALIX ADVANCE KNOTLESS BR ANCHOR
- K130984 — PROFEMUR RENAISSANCE CLASSIC HIP STEM
- K131019 — ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM
- K131088 — PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
- K131156 — LANX SPINAL FIXATION SYSTEM
- K131209 — TERASON USMART3200T ULTRASOUND SYSTEM
- K131246 — CORONIS 3MP
- DEN130002 — TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
- K122978 — SANICLAVE 102, MODEL RS-SC-102
- K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD
- K123937 — ATOM TRANSCAPSULE V-707
- K130115 — DISCOVERY MR750W 3.0T
- K130430 — IVAS 10MM AND 15MM BALLOON CATHETER
- K122625 — GETINGE 800HC- SERIES STEAM STERILIZER
- K123133 — BARLE TISSUE ADHESIVE
- K123662 — THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM
- K130444 — H-30 HOLMIUM LASER SYSTEM
- K130524 — BREATHID HP SYSTEM
- K130538 — WINX SLEEP THERAPY SYSTEM
- K130551 — CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
- K130804 — UROMAX ULTRA BALLOON DILATATION CATHETER
- K131299 — ANYTHINK PACS WORKSTATION
- K122214 — TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)
- K122519 — DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
- K122705 — HUMICARE D900
- K122735 — SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
- K123322 — ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
- K123726 — COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
- K130077 — REMSTAR SE
- K130189 — XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)
- K130539 — HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)
- K130842 — ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES
- K131093 — ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
- K131119 — SOLANAS POSTERIOR STABILIZATION SYSTEM
- K122804 — ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM
- K123115 — ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
- K123306 — NORDIC TUMOREX
- K123428 — MIROCAM CAPSULE ENDOSCOPE SYSTEM
- K130146 — SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
- K130457 — 3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL
- K130943 — AIGIS RX R PM/ AIGIS RX R ICD
- K120671 — DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
- K120749 — HUMAN IGG CSF KIT
- K120750 — HUMAN IGM CSF KIT
- K121976 — AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
- K122417 — SCOPEVALET DISPOSABLE BIOPSY VALVE
- K122974 — TRYOUT-VPS HOLDING PASTE
- K123022 — NEODENT IMPLANT SYSTEM
- K123510 — MAGNETOM SKYRA
- K123603 — OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME
- K123821 — AIO HD OTOSCOPE
- K124034 — MECTALIF ANTERIOR
- K124051 — THE VAULT SYSTEM
- K130037 — BREATHE CPAP SYSTEM
- K130105 — RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM
- K130377 — KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM
- K130451 — NEUROQ 3.6
- K130533 — SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS
- K130558 — SOMNODENT HERBST; CLASSIC, FLEX
- K130647 — XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML
- K130885 — MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT
- K130922 — ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
- K122124 — PORTABLE X-RAY SYSTEM
- K122614 — VINTAGE MP PRESS OVER
- K122644 — ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21
Data sourced from openFDA. This site is unofficial and independent of the FDA.