FDA 510(k) clearances — page 627
clearances on record, most recent first.
Clearances — page 627
62,601–62,700 of 176,637- K061912 — FUSION
- K053654 — ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE
- K060556 — BRIGIT SURGICAL DEVICE
- K060584 — NC-STAT
- K060966 — COOLTOUCH VARIA ND:YAG LASER SYSTEM
- K061247 — DIASORIN LIAISON TREPONEMA ASSAY
- K061266 — ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR
- K061268 — G-LIX TISSUE GRASPER
- K061374 — INTUITION INFUSION SETS
- K061424 — CELSITE/ CELSITE CONCEPT, ACCESS PORTS
- K061807 — SPI ART ABUTMENTS
- K061837 — NXSTAGE CARTRIDGE EXPRESS
- K061981 — SURPASS
- K062050 — FLEXVIEW SYSTEM
- K062052 — LMT NOMAG IC 3.0
- K060320 — FEMECC ENDOCERVICAL CURETTE
- K060354 — ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000
- K060906 — CALYPSO 4D LOCALIZATION SYSTEM
- K060983 — BIOPSY MEDIUM, MODEL REF 1062
- K061094 — NEWPORT E500 WAVE VENTILATOR
- K061102 — PRIMA ANAESTHESIA MACHINE
- K061241 — BIOLUCENT APPLICATOR, MODEL RTA-XX
- K061368 — DIAGNOSOFT HARP
- K061561 — HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE DENSITOMETERS
- K061580 — ECLIPSE WAX REMOVER
- K061673 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML
- K061715 — MRGFUS GENERAL PURPOSE AND BREAST COIL
- K061758 — ACTIVE RENIN IRMA
- K061803 — STA - CONTROL LA 1+2
- K061913 — IBA PROTON THERAPY SYSTEM - PROTEUS 235
- K061930 — INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
- K061952 — CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16
- K062024 — DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
- K052957 — IMPLANTIUM PROSTHETICS
- K060187 — TOPSLANE DMLC
- K061180 — KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR
- K061204 — MASIMO SET RADICAL 7 PULSE CO-OXIMETER
- K061220 — URGOTUL AG
- K061423 — M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
- K061621 — SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS
- K061640 — INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
- K061643 — ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
- K061854 — XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM
- K061865 — FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
- K061964 — SYNGO MULTIMODALITY WORKPLACE
- K051595 — TSO3 OZONE STERILIZER, MODEL 125L
- K060018 — TRULENE MESH
- K060471 — FSSB NYLON SURGICAL SUTURES
- K060973 — VYCOR SURGICAL ACCESS SYSTEMS
- K061162 — BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020
- K061285 — SMARTSITE NEEDLE FREE VALVE ADMINISTRATION SETS
- K061476 — ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
- K061482 — ALTES BUTTRESS PLATING SYSTEM
- K061501 — FLEXO DENTAL RESIN MATERIAL
- K061599 — PIN SCREW
- K061620 — IFS CANNULATED BONE SCREW
- K061784 — INSORB ABSORBABLE STAPLE, MODEL 1020
- K053446 — GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088
- K060037 — FITPACK
- K060527 — INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST
- K060540 — XPERT, GENEXPERT DX SYSTEM
- K060769 — HYDROMARK BIOPSY SITE MARKER
- K060793 — ELEMENT BLOOD GLUCOSE TEST SYSTEM
- K060808 — BRAINPRO, BRAINPRO ACCESS
- K060898 — PULSION PICCO PLUS, MODEL 8100
- K061331 — ORAL BALANCE LIQUID/ GEL
- K061405 — APNEALINK, MODEL 22302
- K061421 — ERAD PACS
- K061429 — DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA
- K061441 — EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
- K061449 — SYNGO EXPERT-1
- K061582 — VARISOURCE 200 HDR AFTERLOADER
- K061637 — ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO
- K061657 — HITCH LACTOSORB SUTURE ANCHOR
- K061665 — ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT
- K061724 — POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)
- K061893 — INTEGRA RADIONICS XKNIFE RT 4
- K061915 — CD HORIZON SPINAL SYSTEM
- K061947 — 21.3 INCH MONOCHROME LCD MONITOR
- K061962 — SURGI-CUF REUSABLE, RS SERIES
- K052668 — OR SPECIFIC BIG CASE BACK TABLE COVER
- K053490 — MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
- K061151 — PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)
- K061229 — UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
- K061786 — VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS
- K051958 — MP RAPIDOXY TEST STRIP, MODEL 07RD-7073
- K053597 — I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)
- K060205 — GENERAL CHEMISTRIES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER
- K060489 — DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
- K060619 — DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A
- K060739 — MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307
- K060895 — NOMOSSTAT, VERSION 1.0
- K060998 — QMS TOBRAMYCIN
- K061387 — VERESURE BELL
- K061418 — QUANTIVA
- K061447 — 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)
- K061530 — MD-TEMP
- K061556 — AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020
- K061574 — COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
- K061588 — VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.