FDA 510(k) clearances — page 1653
clearances on record, most recent first.
Clearances — page 1653
165,201–165,300 of 175,890- K810022 — SRD III
- K810062 — BI-CENTRIC BI-POLAR ENDOPROSTHESIS
- K810063 — AUTOMATIC BIOCHEMICAL ANALYZER
- K810064 — PULSARII, HIGH VOLT. GALVANIC MUSC. STIM
- K810082 — ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT
- K810084 — MAGNESIUM KIT
- K810089 — 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI
- K810090 — CHOLESTEROL REAGENT
- K810091 — GLUCOSE STANDARD
- K810107 — RESPA-TROL
- K810109 — METAL SPLINTS
- K810110 — COBBLER'S CHIP SPLINTS
- K802806 — VISECERA RETAINER
- K803111 — ERECTAID
- K803191 — PROSTHESIS, HIP FEMORAL COMPONENT METAL
- K803192 — HCL ACETABULAR COMPONENTS
- K810018 — SURG-FLEX 5 SURGICAL LIGHT
- K810019 — SURG-FLEX 15 SURGICAL LIGHT
- K810021 — FLO-TEMP
- K810024 — BONNER BRACE
- K810035 — PRENATAL SUPPORT PILLOW
- K810057 — GALVANATOR 725
- K810061 — CURVED SHERMAN BONE PLATE
- K802113 — SIRECUST 400 SYSTEM PATIENT MONITORING
- K802717 — HP MODEL 4710A ECG TRANSMITTER
- K802756 — SEMI-OVAL MODULAR SUNTANNING BOOTH
- K802970 — TERUMO HOLLOW FIBER OXYGENATOR
- K802979 — DIASONICS SMALL PARTS SCANNER
- K803003 — INTERPULSE MEMBRANE OXYGENATION SYSTEM
- K803032 — PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.
- K803090 — SUNMAKER (SUN TANNING BED)
- K803103 — TECHNY REX 3000 MOBILE X-RAY UNIT
- K803120 — TILTING IMAGING TABLE #846T
- K803124 — SIDOS U.
- K803197 — IMPL. PROGRAMMABLE BIPOLAR CARD.GEN.#274
- K803257 — CSG-FLOW CONTROL VALVE
- K803315 — CRITERION II RHYTHM PROFILE MONITOR
- K810068 — PEDIATRIC ARTERIAL BLOOD FILTER
- K802438 — MARK V DUPLEX ULTRASONIC SCAN SYS.
- K802754 — IMMUNOREACTIVE ESTRIOL RIA KIT
- K802765 — ACRODISC FILTER ASSEMBLY
- K803186 — NORMAL AND ELEVATED CONTROL FOR GLYCO.
- K803200 — IRRIGATION SET W/BULB SYRINGE
- K803204 — IRRIGATION PISTON
- K803206 — SUCTION PROBE
- K803219 — ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.
- K803278 — LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT
- K810003 — 'NO-BOIL' FOLIC ACID KIT
- K810033 — CORTI-SHURE
- K801771 — ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT
- K802361 — DIALYIS START CARE KIT
- K802539 — DISPOSABLE GAS LINE FILTER
- K802541 — DISPOSABLE PARALLEL Y CONNECTORS
- K802542 — DISPOSABLE CONNECTORS
- K802543 — RIDGID VENA CAVA CANNULAE
- K802544 — DISPOSABLE QUICK RELEASE PERFUSION ADAP
- K802545 — CARDIOPLEGIC SETS
- K802547 — PERMANENT & TEMP. PACEMAKER ELECTRODE
- K802552 — PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE
- K802553 — PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN
- K802816 — ENDOCARDIAL LEADS 414S & 515S
- K802832 — SANDARE GLYCOHEMOGLOBIN PROCEDURE
- K802917 — MARK III ULTRASONIC SCANNING SYSTEM
- K803058 — SWAN-GANZ FLOW-DIRECTED MULTIPUR. CATH.
- K803182 — SYRINGE FOR BLOOD SAMPLING
- K803231 — THB 6000 HARDSHELL BUBBLE OXYGENATOR
- K803267 — AUTOMATED IMMUOCHEMISTRY SYSTEM
- K803273 — PROLACTIN (125) RADIOIMMUNAOASSAY
- K803279 — FOLLICE STIMULATING HORMONE-RADIOIMM. KT
- K803280 — HUMAN GROWTH HORMONE-RADIOIMM. KIT
- K803281 — AUTOMATED ELECTROPHORESIS SYSTEM
- K803285 — PHOTOMETER
- K803287 — CHOLESTEROL REAGENT ENZYMATIC
- K803296 — ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT
- K803297 — LUQUIZYME TRIGLYCERIDE REAGENT SET
- K803301 — CREATINE KINASE REAGENT
- K803305 — DUPONT 'ACA' CREATINE KINASE VERIFIERS
- K803309 — VITASTAT ECG-1/ECG-3 ELECTROCARDIOGRAPH
- K810001 — 'NO-BOIL' DUALCOUNT KIT
- K810002 — 'NO-BOIL' VITAMIN B12 KIT
- K810008 — ALP-KII
- K810028 — FETAL BLOOD SAMPLING KIT MODEL 1560
- K802406 — CYTOTRAN I BONE MARROW ASPIRATION SYSTEM
- K802437 — MARK III ULTRASONIC SCANNING SYSTEM
- K802801 — GE RT/PLAN MAGNETIC TAPE DRIVE OPTION
- K802829 — SCANLAN VASCU-STATT
- K802885 — L.A.F. ISOLATION PACK
- K802905 — MULTI-IMAGE CAMERA-#627 TLC
- K802940 — SUPER-SPIKE TRANSFER SET
- K802943 — POSITIVE END EXPIRATORY PRESSURE VALVE
- K802972 — DUAL-TROL
- K803125 — BONE-DRI SURGICAL SPONGE
- K803131 — LKB-WALLACE 1250 LUMINOMETER
- K803156 — SURGITEK MEDI-LOOPS
- K803158 — IRRADIATED BOUNDARY DEVICES
- K803172 — GAUZE SPONGES
- K803188 — GAUZE SPONGES
- K803198 — IRRIGATION SET W/PISTON SYRINGE
- K803199 — SUTURE REMOVAL KIT
- K803207 — REGULATOR, OXYGEN MECHANICAL
Data sourced from openFDA. This site is unofficial and independent of the FDA.