FDA 510(k) clearances — page 555
clearances on record, most recent first.
Clearances — page 555
55,401–55,500 of 176,542- K082655 — ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1; OOM103/-1/-1M; OOM104; OOM105; 00M106
- K082838 — ORLUS MINI SCREW
- K082844 — BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE
- K082861 — AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561
- K082949 — ORTHOPEDIATRICS BONE SCREWS
- K083139 — VIPERSPHERE PTA BALLOON CATHETER
- K081943 — MODEL ES-130
- K082002 — PROGENIX PLUS
- K082572 — USS ILIOSACRAL, USS POLYAXIAL
- K082753 — FUTURABOND M/FUTURABOND M SINGLE DOSE
- K082807 — SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS
- K082881 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3
- K082963 — WU'S 4-WHEELED NEO SCOOTER, WT-M3A
- K083228 — PHILIPS INTELLIVUE MP5 PATIENT MONITOR
- K072664 — GE LUNAR FEMUR STRENGTH SOFTWARE
- K073390 — DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS
- K080430 — STOMA BONE BLOCK SCREW
- K081025 — ISOELASTICU
- K081080 — TSRH SPINAL SYSTEM
- K081287 — SAPPHIRE PLASMA ARC DENTAL CURING LIGHT
- K081460 — TDS ABUTMENT
- K081713 — VERTEBRAL ACCESS SYSTEM BY VIDACARE
- K082125 — N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT
- K082349 — JARIT HULKA UTERINE TENACULUM FORCEPS
- K082432 — CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM
- K082441 — NORDICICE SOFTWARE
- K082506 — SYMBIA, VERSION 4.0
- K082508 — FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD
- K082553 — REXASTOM ORAL EASE
- K082604 — VIZTEK DR, MODELS: DR1000, DR3000, DR4000
- K083048 — NEORAY DR 2520 DIGITAL IMAGING SYSTEM
- K083125 — NEURON SELECT CATHETER SIZE 070
- K083146 — ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
- K083189 — STERI-LUB LUBRICATION GEL
- K083255 — 16CH AI BREAST COILS 1.5 T AND 3 T
- K082205 — FACTOR VIII ANTIBODY SCREEN
- K082240 — SNTRYPACS
- K082284 — AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM
- K082299 — VERICORE IMPLANT ABUTMENTS
- K082339 — ENABLER-P SUPPORT CATHETER
- K082538 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST
- K082579 — EVERCROSS .035 OTW PTA DILATATION CATHETER
- K082628 — CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23
- K082990 — INFINITT XELIS
- K082991 — BIOLOX DELTA CERAMIC FEMORAL HEAD
- K083076 — STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 46836
- K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES
- K073667 — NITI-S BILIARY STENT
- K081313 — SH14 HEMOCONCENTRATOR
- K081380 — THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS
- K081505 — THERAGEM PROFESSIONAL T1002
- K082714 — AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5
- K082773 — STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331
- K082851 — MULTLINK CABLE AND LEADWIRE SYSTEM
- K083100 — GOLDADAPT NON-ENGAGING NOBELACTIVE NP & RP, GOLDADAPT ENGAGING NOBELACTIVE NP & RP
- K073087 — NON-CONTACT TONOMETER, MODEL FT-1000
- K081685 — LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
- K081940 — AVALON ELITE VASCULAR ACCESS KIT
- K082276 — SYNTHEMED DEVICE
- K082347 — DIGITAL RADIOGRAPHY, FLEXDR C30
- K082348 — FIBERNET EMBOLIC PROTECTION SYSTEM
- K082354 — STEREO NAVIGATOR ACCESSORY, STN-1000
- K082500 — DEPUY SIGMA CR-F FEMORAL COMPONENT
- K082650 — SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
- K082907 — IC-PRO SYSTEM, VERSION 3.1.0.4
- K083227 — VIDA PULMONARY WORKSTATION 2 (PW2)
- K080623 — CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
- K080796 — SRI LP DRAPE
- K080823 — EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
- K081981 — LANG DENTAL ACRYLIC PRIMER
- K082568 — SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE
- K080460 — SPECTRAL OCT/SLO
- K080591 — TANDA SKINCARE SYSTEM, MODEL: PTSCS
- K081123 — NEXUS I.V. NEEDLESS ACCESS CANNULA FOR INTRAVASCULAR ADMINISTRATION SETS
- K081335 — TENACORE OXYGEN BLENDER, MODEL TB-2000
- K081673 — DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE
- K081805 — CUFFALERT
- K081906 — PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
- K081986 — SAFESEPT TRANSSEPTAL TROCAR GUIDEWIRE
- K082108 — OBC BONE ANCHORED HEARING AID SYSTEM
- K082128 — DEPUY SPINE LATERAL CAGE SYSTEM
- K082176 — LTM-BPS SURGICAL MESH
- K082211 — RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS
- K082322 — AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS
- K082381 — GENEX
- K082430 — SYNGO IMAGING XS
- K082434 — GDLS-200
- K082581 — C-QUEST
- K083018 — CENTRICITY PACS WEB DIAGNOSTIC
- K083071 — VERTEX RECONSTRUCTION SYSTEM
- K083207 — ULTRAWAVE III EX 1320
- K073689 — LEP2000 THERAPY SYSTEM
- K080442 — SERISCAFFOLD SURGICAL MESH
- K080707 — SRI PLR GOWN
- K080723 — SRI LP GOWN
- K081818 — BIOLOK MICRO-LOK IMPLANT SYSTEM
- K082126 — RHAPSODY MRI
- K082142 — ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
- K082187 — BIOMET ANTERIOR LUMBAR PLATE
- K082392 — EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.