FDA 510(k) clearances — page 720
clearances on record, most recent first.
Clearances — page 720
71,901–72,000 of 175,825- K031050 — PCW PERCUTANEOUS COMPRESSION WIRE
- K031067 — FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS
- K031181 — EXTERNAL FIXATION SYSTEMS
- K031183 — TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
- K031203 — BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST
- K031724 — SYNTHES SMALL COBINATION CLAMP-MR SAFE
- K031737 — BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
- K031784 — ACON STREP A RAPID TEST DEVICE
- K032008 — VAXCEL WITH PASV PORT, MODEL 45-213
- K030788 — KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
- K031914 — SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE
- K024343 — BUTLER GUM PROPHY PASTE WITH NOVAMIN
- K030456 — VASC-ALERT
- K030547 — MODIFICATION TO ZAP GUARD DEFIBRILLATOR TEST PROBE
- K030600 — AUTION JET AJ-4270 URINE ANALYZER
- K030703 — TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS
- K030754 — A/C ENZYMATIC HOMOCYSTEINE ASSAY
- K030841 — COOK GASTRIC SIZING BALLOON CATHETER
- K030991 — C. DIFF CHEK - 30
- K030992 — C. DIFF CHEK - 60
- K031060 — NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES
- K031212 — TEMPORARY RESIN CEMENT
- K031339 — OPTIBOLUS
- K031366 — PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL
- K031417 — ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1
- K031589 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE
- K031720 — MODIFICATION TO HERMES O.R. CONTROL CENTER
- K031808 — MEDRAD SWABBABLE VALVE TRANSFER SET
- K031823 — HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
- K032036 — GEMINI 16
- K030760 — COACH 888W
- K030852 — 4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX
- K031036 — GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03
- K031045 — AEROLET TOILET LIFT, MODEL AER-01
- K031059 — IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
- K031093 — EBI XFIX OPTIROM KNEE FIXATOR
- K031115 — RH-900
- K031174 — BODY SIGNAL ECG ELECTRODE
- K031342 — JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II
- K031410 — VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
- K031482 — CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE
- K031530 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML
- K031716 — SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE
- K032044 — X-PROT DUO PORT
- K030638 — DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML
- K031199 — ENTERALITE INFINITY ENTERAL FEEDING PUMP
- K031229 — TELZUIT CARDIAC MONITORING SYSTEM
- K031824 — COBAS INTEGRA CHOLESTEROL GEN. 2
- K031868 — PROPHYPEARLS
- K031913 — VINYL EXAMINATION GLOVES, POWDER FREE, VIOLET COLOR
- K032040 — IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
- DEN030004 — WEST NILE VIRUS IGM CAPTURE ELISA
- K022558 — NGT
- K022967 — SUILE WOUND DRESSING
- K023836 — THE SUAD DEVICE
- K031118 — INTRAOS 70
- K031163 — SEZ SAFETY SYRINGE
- K031258 — CYNOSURE PHOTOLIGHT PL
- K031453 — TERUMO SURGUARD 2 SAFETY NEEDLE
- K031555 — SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
- K031690 — CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM)
- K031929 — 5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
- K020332 — RESPIRATORY HUMIDIFIER, MODEL MR850
- K024204 — FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM
- K030076 — PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM
- K030271 — VENTLAB BACTERIAL FILTER, MODEL BF100
- K030470 — NXSTAGE SYSTEM ONE
- K031055 — ITI DENTAL IMPLANT SYSTEM
- K031208 — REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
- K031383 — MODEL 780
- K031777 — MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K031905 — DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136, AND ACT 3030
- K024303 — EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
- K024337 — GENERAL SEMEN ANALYSIS (GSA) KIT
- K030329 — FASTPACK FREE T4 IMMUNOASSAY
- K030919 — SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
- K031070 — CARBON FIBER BRIDGE, MODEL 28757
- K031133 — SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS
- K031193 — SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION
- K031422 — PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
- K031484 — STAND OUT
- K031623 — MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
- K031755 — ACCU-CHEK COMPACT TEST STRIP
- K031843 — MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
- K023179 — READI-STRAND, MODEL PSSTRAND
- K024080 — SECQUIRE CELL SEPARATOR
- K024191 — S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK
- K024307 — DERMOSONIC NON-INVASIVE SUBDERMAL THERAPY SYSTEM
- K030113 — MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23
- K030899 — C-REACTIVE PROTEIN (CRP)
- K031276 — SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM
- K031372 — PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION
- K031444 — OPTIBOND FL
- K031476 — FILL-IN
- K031478 — MICROHEATER
- K031688 — RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE
- K031718 — LIFEVALVE CENTRAL VENOUS CATHTER
- K031719 — ESTHETIC ZIRCONIA ABUTMENT
- K031747 — SPI DENTAL IMPLANT ABUTMENTS
- K031790 — SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING
Data sourced from openFDA. This site is unofficial and independent of the FDA.