FDA 510(k) clearances — page 515
clearances on record, most recent first.
Clearances — page 515
51,401–51,500 of 176,542- K091716 — MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY
- K091933 — ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01
- K091955 — STRYKER SONICPIN SYSTEM
- K092076 — AEGIS & AEGIS II SPINAL SYSTEM
- K092481 — HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
- K092484 — HELIOX LOW FLOW SENTRY BLENDER
- K092530 — SPRYTIE, MODELS ST001, ST002 AND ST003
- K092579 — INTRAUTERINE INSEMINATION (IUI) CATHETER
- K092785 — COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301
- K093135 — VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE
- K093305 — ENHANCED ULTRA VIT PROBE
- K093321 — BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM
- K093333 — PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8
- K093555 — COBAS U411 TEST SYSTEM
- K093706 — PROXISCAN MODEL 101
- K093858 — PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
- K100120 — ALEXIS ORTHOPAEDIC WOUND RETRACTOR
- K100230 — SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V
- K092391 — MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED
- K093009 — MACH LED SC
- K093010 — MACH LED MC
- K093205 — PADCHECK
- K093400 — 1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2
- K093506 — CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267
- K093844 — SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR
- K093869 — SE-601 SERIES ELECTROCARDIOGRAPH
- K100594 — ELECSYS TROPONIN I CALCHECK 5
- K100633 — INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016
- K093872 — HANDHELD ECG MONITOR, MODEL MD100
- K100314 — IMNS MEDACTA NAVIGATION SYSTEM,33.221000US
- K100575 — LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
- K091313 — SYSMEX MODEL XT-4000I
- K092448 — HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
- K092849 — BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER
- K093016 — VITAL SIGNS MONITOR
- K093494 — LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
- K093633 — INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE
- K100401 — SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM
- K100559 — MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
- K100615 — ARSTASIS ACCESS SYSTEM
- K100641 — INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)
- K100671 — NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
- K100712 — RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
- K091616 — BIOPLEX 2200 MMRV IGG
- K092493 — GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM
- K093582 — ELECSYS CK-MB CALCHECK 5
- K093772 — SYNTHES STERNAL FIXATION SYSTEM
- K093928 — SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
- K100236 — STAIR SYSTEMS PACS & DICOM VIEWER
- K100270 — ARTISAN AESTHETIC SYSTEM
- K100324 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K100337 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K100555 — APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK
- K100722 — TELAVANCIN 30 UG, BBL SENSI-DISC
- K091940 — MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
- K092061 — FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217
- K093257 — TORQMAX SHEATH GRIP ACCESSORY
- K093261 — MOVES
- K093524 — PIVIT A/B ST AND PIVIT A/B ST-R
- K093776 — INDUS ANTERIOR CERVICAL PLATE SYSTEM
- K093941 — CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265
- K100062 — INFILTRATION KIT
- K100527 — HOVEROUND TEKNIQUE, MODEL HD-6
- K100579 — G-FORCE TI SUTURE ANCHOR SYSTEM
- K091538 — PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100
- K091978 — DBB-06 HEMODIALYSIS DELIVERY SYSTEM
- K092437 — CODMAN STERILIZATION CONTAINERS
- K093406 — MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519
- K093831 — FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT
- K093896 — ETHICON ENDO SURGERY SLOTTED ANOSCOPE
- K093976 — RAISIN PERSONAL MONITOR
- K100510 — CERAMIR CROWN & BRIDGE
- K091890 — EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT
- K092046 — BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY
- K093003 — BONASTENT BILIARY
- K093808 — INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE
- K093984 — PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01
- K100162 — MULTIPLE PRIVATE LABEL
- K100186 — MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM
- K100280 — GYNCARE MORCELLEX TISSUE MORCELLATOR
- K100317 — DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO
- K100326 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K100385 — NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP
- K100507 — XRES BLOOD COLLECTION RESERVOIR
- K083842 — ROTEM DELTA THROMBOELASTOMETRY SYSTEM
- K090364 — EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE
- K093048 — D-STORM 810NM, D-STORM 980NM
- K094006 — OPAL BOND MV
- K094044 — SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT
- K092584 — LAPORT
- K093240 — BELRAY II
- K093535 — AUTOLOG AUTOTRANSFUSION SYSTEM
- K093731 — VPAP III ST-A
- K093732 — ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
- K093791 — GORE DRYSEAL SHEATH
- K093946 — HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2
- K093998 — KNEEALIGN SYSTEM WITH REFERENCE SENSOR
- K094047 — 18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR
- K100303 — ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY
- K100327 — HEARTWAY POWER CHAIR, P23
Data sourced from openFDA. This site is unofficial and independent of the FDA.