FDA 510(k) clearances — page 504
clearances on record, most recent first.
Clearances — page 504
50,301–50,400 of 176,542- K101719 — TACAMO MANUAL WHEELCHAIR
- K101728 — FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
- K102175 — RAPIDVUE HCG TEST
- DEN090002 — ZELTIQ AESTHETICS DERMAL COOLING DEVICE
- DEN090008 — ERCHONIA ML SCANNER (MLS)
- K093373 — LARYNGEAL SURFACE ELECTRODE
- K093954 — BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
- K101168 — LEGEND POWER ADAPTER MODEL: 6475000
- K101358 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K101632 — METAFLEXCOIL
- K102235 — MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM
- K093204 — INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM
- K093510 — LUMENVU CATHETER GUIDANCE SYSTEM
- K093783 — INNOVIA INNOPORT LAPAROSCOPIC ACCESS PORT
- K093916 — NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U
- K101068 — ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS
- K101335 — CELL-CHEX
- K101603 — BEAUTIFIL FLOW PLUS
- K101621 — LITE ART
- K101875 — BK BLANK MODEL 20,40,65,90
- K102082 — EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
- K092767 — BBL CHROMAGAR MRSA II
- K093043 — ZIRCONIA SYRINGE NEEDLE
- K093269 — PROCEDURE REHEARSAL STUDIO
- K093622 — AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015
- K100512 — NOBELPROCERA IPS E.MAX CROWN
- K100753 — FLIGHT 60 VENTILATOR, MODEL F-60
- K101272 — MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3
- K101342 — OSIRIX MD
- K101359 — INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)
- K101717 — DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING
- K100841 — BONEOPTIMIZER
- K100912 — DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
- K101213 — GRANDIO FLOW
- K101329 — SYNERGY CT PICC
- K101493 — ADVANCED GLASS IONOMER (K-130) RESTORATIVE
- K101789 — REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
- K101798 — SPI VARIOMULTI ANGLED ABUTMENT
- K101816 — STN PROBE
- K091047 — NEONATE ARRAY COILS
- K091424 — OSTA MAXIGRO AND REGIGRO
- K093785 — MODULAR ENDOSCOPE
- K101152 — NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810
- K101704 — ZIMMER DTO PIN PRESS INSTRUMENT
- K101709 — LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)
- K094043 — LIGAMENTOTAXOR
- K100245 — HS/HG PROSTHETIC SYSTEM
- K100354 — PRIMAL OK INTERSPINOUS FUSION SYSTEM
- K100843 — ABREU, MODEL 700
- K100975 — NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
- K100988 — HUMAPEN LUXURA HD
- K101038 — RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER
- K101098 — REPLENS LONG-LASTING VAGINAL MOISTURIZER (35G TUBE WITH REUSABLE APPLICATOR) MODEL: 83035
- K101241 — REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR)
- K101325 — STELLARIS PC VISION ENHANCEMENT SYSTEM
- K101424 — PHARMACARIBE INHALED SALINE SOLUTIONS
- K101565 — POWDER - FREE PATIENT EXAMINATION GLOVES
- K102012 — DIGITAL RADIOGRAPHY
- K102148 — CURIEPACS (DICOM PACS SOFTWARE)
- K102167 — LO-50 LED LIGHT SOURCE
- K090947 — 21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)
- K100588 — HUMAN IGA2 KIT FOR USE ON THE SPAPLUS
- K100846 — IMC SURGICAL FACE MASK
- K101004 — ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT
- K101029 — KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
- K101364 — LANX FACET SCREW SYSTEM
- K101462 — ASCEND BLUE AC MESH; ASCEND BLUE PC MESH
- K101749 — SYNGO TRUED SOFTWARE
- K092875 — ECHO TD-3227 DUAL BLOOD PRESSURE/BLOOD GLUCOSE METER
- K092991 — O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)
- K093145 — SPECTRA SERIES BREAST PUMP
- K093362 — 2008 HEMODIALYSIS SORBENT SYSTEM
- K093459 — ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01
- K093553 — POSTURETEK
- K100098 — PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE
- K100143 — PILOT DIODE LASER, MODEL 002-00139
- K100179 — SPAPLUS
- K100786 — MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX
- K101150 — PICC WAND PEELABLE SAFETY INTRODUCER
- K101390 — FASTPACK TSH IMMUNOASSAY
- K101623 — INQUIRY AFOCUSII DIAGNOSTIC CATHETER
- K102037 — AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
- K102149 — GAUNYING INFRARED LAMP
- K091692 — AESCULAP PEEK CRANIOFIX
- K093828 — KYPH X HV-R BONE CEMENT
- K100389 — HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT
- K100551 — ORLOCATE SYSTEM MODEL ORL 100
- K100970 — STAINLESS STEEL SPINAL SYSTEM
- K100977 — PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE
- K100978 — POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE
- K101051 — AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX
- K101757 — SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM
- K101967 — NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE'
- K102113 — GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND
- K091310 — ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682
- K093304 — PROTEKTOR 32
- K093692 — QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
- K100156 — COLLAGEN DENTAL MEMBRANE V
- K100865 — AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX
- K101052 — OMNI III PATIENT MONITOR
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