FDA 510(k) clearances — page 540
clearances on record, most recent first.
Clearances — page 540
53,901–54,000 of 175,825- K082296 — COPA AMD
- K082638 — ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL
- K083103 — ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B
- K083424 — BUSSE SURGICAL DRAPE
- K083550 — STRAUMANN DENTAL IMPLANT SYSTEM
- K083654 — ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM)
- K090097 — LH-75T PHOTOTHERAPY SYSTEM
- K090260 — MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS
- K090294 — FORA IR22 EAR THERMOMETER, MODEL TD-1262
- K090453 — SILVER ALGINATE 11 WOUND DRESSING
- DEN070002 — QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING
- K082404 — NAVIGATION PROBES
- K082480 — CONTEC POCKET FETAL DOPPLER
- K082498 — GRAFTYS HBS
- K082583 — INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5
- K082623 — VISIX IMAGING
- K082836 — ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
- K083281 — EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-
- K083324 — LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM
- K083375 — RENASYS GO NEGATIVE PRESSURE WOUND THERAPY
- K083663 — PACP
- K083683 — ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC
- K083691 — BONEVUE
- K083732 — TAD AND TAD II TAPERED GUIDE WIRES
- K082286 — BIOACTYS
- K083541 — NEONATE HEAD AND BODY COILS
- K083645 — RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS
- K080008 — BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
- K081541 — DERMABLATE EFFECT
- K082693 — RESOLUTIONMD, RELEASE 2.1
- K083056 — NEO-STAT CO2 <KG
- K083101 — PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES
- K083178 — SOLAS ANATOMIX SPINAL SYSTEM
- K083229 — E.S TECK ( ELECTRO SENSOR TECK)
- K083641 — BIVONA TRACHEOSTOMY TUBES
- K083710 — RETRACTOR LITE
- K083713 — .035 LOC GUIDE WIRE EXTENSION
- K083752 — GLUSEAL 90, MODEL GLU9010
- K083879 — INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)
- K090378 — CHROMOPHARE E 668
- K073439 — TRANSITION STABILIZATION SYSTEM
- K080481 — ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
- K080853 — DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM
- K080874 — EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT
- K081255 — SCRAMBLER ST 5 TENS DEVICE
- K081400 — FANNING-PAPPAS MODULAR KNEE BEARING
- K081419 — STRAUMANN DENTAL IMPLANT SYSTEM
- K081479 — ADVANCE A-CLASS TIBIAL INSERT
- K081540 — ZEGRA POSTURE TRAINER
- K082201 — G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A
- K083051 — FLOWTAIN & FLOWTAIN LV
- K083225 — FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
- K083399 — ICS CHARTR EP 200
- K083516 — PERIOGENIX
- K083565 — PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0
- K083579 — DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
- K083727 — STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012
- K083778 — XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
- K083786 — CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB
- K090133 — CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
- K090162 — EVICEL APPLICATION DEVICE
- K090177 — INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE
- K090242 — GAMMA-BSM, BETA-BSM
- K090334 — ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
- K082124 — CARDITTE MICROTEL
- K082775 — PRESCISION OPTION
- K083009 — ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
- K083488 — JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
- K083491 — NEUROSCAPE
- K083497 — ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS
- K083556 — MODIFICATION TO AUTO-BAND LIGATOR
- K083600 — VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)
- K083629 — SMOOTHSHAPES
- K090212 — MAC 800 RESTING ECG ANALYSIS SYSTEM
- K090276 — ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM
- K090296 — ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
- K080733 — COTTONS 100% NATURAL COTTON TAMPONS
- K081137 — INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000
- K082117 — QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000
- K082300 — ANATOMIC LOCKING PLATING SYSTEM
- K082468 — APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60)
- K082791 — EMS AIR-FLOW MASTER
- K082992 — AXXION LIGHT GUIDE
- K083252 — NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM
- K083262 — MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)
- K083383 — VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
- K083735 — ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS
- K090275 — GELPORT SINGLE INCISION ACCESS SYSTEM
- K082921 — RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
- K083259 — PATIENT VINYL EXAMINATION GLOVES, POWDERFREE, NON-STERILE
- K083533 — ECHELON C MRI SYSTEM
- K083639 — MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE
- K083745 — THE IC-PRO SYSTEM, MODEL VERSION 3.2
- K083855 — MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59
- K090135 — TRIMIRA IDENTAFI 3000
- K090202 — NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125
- K080105 — ENDOTRACHEAL TUBE
- K080635 — MEDTOXSCAN
- K080636 — DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100
- K081264 — STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
Data sourced from openFDA. This site is unofficial and independent of the FDA.