FDA 510(k) clearances — page 652
clearances on record, most recent first.
Clearances — page 652
65,101–65,200 of 176,637- K042352 — BIODERM SCIENCES WOUND CREAM
- K051531 — TECTONIC CERVICAL PLATE SYSTEM
- K051543 — ELECSYS PRECICONTROL BONE
- K051815 — MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
- K051976 — PROVEN REVISION MODULAR TIBIAL TRAY
- K052025 — URGENT PC NEUROMODULATION SYSTEM
- K052043 — 3.8MM CS FACET COMPRESSION DEVICE
- K052124 — ACTICLOT, MODEL 824
- K052175 — I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
- K052189 — REVENEER CERAMIC REPAIR SYSTEM
- K052284 — REFORMAT GATEWAY
- K052351 — HDR IORT SHIELDED APPLICATOR
- K052365 — CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE
- K052368 — OLECRANONPLATE WITH ANGULAR STABILITY
- K052443 — ICY CATHETER, MODEL IC-3893A
- K052449 — CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189
- K052482 — ARTELON SURGICAL SUTURE
- K052498 — FRAGMENT SPECIFIC FIXATOR
- K052500 — DAR-8000F
- K052571 — MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0
- K052630 — ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
- K052633 — DUAL SHOT - CONTRAST DELIVERY SYSTEM
- K052660 — MODEL 672-BD, HOME UVB LIGHT SOURCE (JORDAN LIGHT); MODEL 2400, 4 (6 FOOT) HO UV LIGHT SOURCE; MODEL 2600, 6 (6 FOOT) HO
- K052673 — KING I POWERED SCOOTER, MODEL CTL-11
- K052740 — NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM
- K052805 — MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150
- K052806 — BURANE
- K050265 — CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
- K050970 — MILO DENTAL IMPLANT SYSTEM
- K051705 — IPS E.MAX CAD/IPS E.MAX ZIRCAD
- K052070 — ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA
- K052085 — STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES
- K052463 — PROMETAL HN86
- K052582 — DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES
- K051626 — IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS
- K051645 — EVIS EXERA 160A SYSTEM
- K051805 — KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE
- K052171 — ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE
- K052244 — IISIS, VERSION 1.0
- K052366 — ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA
- K052547 — BELMONT BUDDY FLUID WARMER
- K052552 — HYBRID ANTERIOR CERVICAL PLATE SYSTEM
- K052600 — ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED)
- K052755 — DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT
- K051480 — ENTERAL FEEDING TUBE
- K051928 — AUTOCHECK6+
- K051959 — NV CORMED SOLAS SPINAL SYSTEM
- K051977 — SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS
- K052497 — NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A
- K052658 — SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET
- K052677 — SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP)
- K050373 — UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS
- K051680 — DYNATRON DX2 TRACTION UNIT
- K051912 — COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B
- K052003 — VNUS RFS, MODEL RFS-6-XX (XX = 10, 12, 13, & 15); VNUS RFS FLEX, MODEL RFX-6-XX (XX = 10, 20, 30 & 40)
- K052163 — ADVIA IMS GLUCOSE ASSAY
- K052279 — COOK IRELAND ECHOBRUSH
- K052336 — SPECTRAQUATTRO PULSED LIGHT SYSTEM
- K052440 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
- K052495 — ATRILAZE MALLEABLE ABLATION PROBE
- K052528 — AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE
- K052634 — TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE
- K052761 — MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
- K050985 — GLUCODR SUPERSENSOR SYSTEM
- K050997 — EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE
- K051044 — ARCTEC SEMIRIGID PLATING SYSTEM
- K051066 — THERATEST EL-ANA PROFILES
- K051544 — VITALCAREGIVING SYSTEM
- K051607 — NOVASPINE CEMENT RESTRICTOR NSCR
- K051646 — ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
- K051742 — OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
- K051844 — EQUATOR PLUS ACETABULAR CUP SYSTEM
- K051869 — NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
- K051950 — INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321
- K052183 — SORING GMBH SONOCA LIPO
- K052261 — MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
- K052312 — WIDE 5MP (MAMMO) LCD MONITOR SYSTEM
- K052341 — AJEX 9015/135H PORTABLE X-RAY
- K052378 — PROASIA, MODEL L3402
- K052384 — LANX VBR SYSTEM
- K052390 — SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION
- K052486 — PROASIA, MODEL L4501
- K052491 — AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR
- K052538 — S-BONE HIP TOOL
- K052584 — 1.5T 12 CHANNEL BODY ARRAY
- K052621 — 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL
- K052640 — GEMINI RAPTOR
- K052792 — ANTHOLOGY HIP STEM
- K043213 — KOWA VX-10
- K051584 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
- K051987 — FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
- K052141 — STRYKER STILETTO ELECTROSURGICAL PROBE
- K052436 — PLEURX PLEURAL CATHETER KIT, MODEL 50-7000
- K052472 — DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
- K052506 — RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108
- K052549 — LEADCARE II BLOOD LEAD TESTING SYSTEM
- K052681 — START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI)
- K051176 — FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
- K051508 — MED FLASH II INTENSE PULSED LIGHT SYSTEM.
- K051534 — CARDIOLINE AR 600, AR 1200, AR 2100
Data sourced from openFDA. This site is unofficial and independent of the FDA.