FDA 510(k) clearances — page 1560
clearances on record, most recent first.
Clearances — page 1560
155,901–156,000 of 175,890- K831997 — IMPLANTABLE ENDOCARDIAL PACING LEADS
- K832043 — SURGIKEK PENILE PROSTHESIS TAIL EXTEND
- K832116 — ATAC 4700 HEMATOLOGY CELL COUNTER
- K832274 — ASPIRATOR
- K832328 — INTRAMEDULLARY BONE PLUG
- K832395 — HOLTA-MED RECORDER
- K832417 — HYPOTHERMIC MYCARDIAL PROTECTION DEV
- K832428 — PLATELET AGGREGATION REAGENT SET
- K832458 — AUTOMATIC ENDOSCOPE
- K832467 — PORTABLE LIFECARE VENTILATOR PLV-100
- K832519 — ASPIRATING TUBING
- K832520 — SUCTION TIPS
- K832521 — PLASTIC SUCTION TIPS
- K832528 — MGI STRENGTH/FITNESS SYS-MODEL #PU-101
- K832579 — PHYSIOLOGICAL PRESS. MEASUREMENT CATH
- K832604 — PHYSIOLOGICAL PRESSURE MEASUREMENT CATH
- K832784 — ULTRA LIGHT RAAF CATHETER
- K832884 — FIXATION STAPLE DRIVER/EXTRACTOR
- K832987 — PERMANTHANE #866 BIPOLAR COAXIAL
- K833048 — PURGES LINES, PL-45 & PL-33
- K833099 — BIOTRONIK N, BIPOLAR PEB-60/4-N
- K833106 — BIOTRONIK DFH UNIPOLAR PE-60/4-DFH
- K833114 — OXFORD MARK 2 EXTERNAL FIXATOR
- K833130 — TRI-COUNT 7
- K831057 — VIDEO-DILUTION TECH. MARK I INSTRUMENT
- K831245 — TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO
- K831587 — TEMP. REPAIR KIT-DUAL LUMEN CATHETER
- K831829 — KARICKHOFF FLYING CORPUSCLE VIEWER
- K831865 — IONESCU-SHILEY LOW POROSITY COMPOSITE
- K831880 — IONESCU-SHILEY LOW POROSITY AORTIC GRAFT
- K831895 — BLOOD OXYGENATOR 50 70/S
- K831943 — PATIENT MONITOR 788 33A
- K831944 — PATIENT MONITOR #78832A
- K831973 — HARD CONTACT LENS CASE
- K832060 — ACCU-SPHYG
- K832068 — CODY SACCULOTOMY TACK
- K832273 — SURGICAL STOCKINGS
- K832287 — NOVA BALLOON THERMODILUTION INFUSION
- K832298 — BABY LIGHT DOSIMETER
- K832386 — PERCLUDER DL OCCLUDING BALLOON
- K832446 — CATAREX DIAP. EXTRACAPSULAR CATARACT
- K832475 — AXIOM PERFUSSION CANNULA
- K832561 — EPCOR MULTIELECTRODE TEMP. PERVENOUS
- K832625 — TOP THREE WAY STOPCOCK
- K832665 — SATELEC SUPRASSON SP 3055
- K832673 — SATELEC PROPHY UNIT PU-2000
- K832761 — AIR FLUID EXCHANGE PUMP
- K832781 — CURAY-SUPPORT, CORE BUILD-UP MATERIAL
- K832807 — PEDIATRIC ILLUMINATING URETERAL
- K832850 — ELECATH PACEWEDGE DUAL PRESS. BIPOLAR
- K832890 — HEMACOMP 7 OR HEMATIL 7
- K832938 — OCUTOME PARATUBING SET
- K832945 — EAGLE 2000 STERILIZER SERIES GAS/AERA
- K832950 — SCIENTRONICS 10K EYE MAGNET
- K832980 — VXTRA OCUTOME KIT
- K833008 — PERCUTANEOUS NEPHROSTOMY CATHETER
- K833054 — GASTRIC SUMP TUBES
- K833098 — BIOTRONIK DN UNIPOLAR PE-60/4-DN &
- K833101 — BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC
- K833104 — BIOTRONIK D2K UNIPOLAR PE-60/4
- K833108 — BIOTRONIK I-UNIPOLAR PE-60/2-13
- K833242 — DEFLECTING GUIDE WIRE
- K833247 — QUANTAPHASE B-12-COBALMIN-FOLATE-
- K832195 — LUNG POWER
- K830778 — MONITORING KIT AMK-1
- K831287 — E-Z FIT
- K831386 — GROSHONG CATHETER, LONG TERM TYPE
- K831407 — CARDIAC OUTPUT COMPUTER
- K831424 — THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
- K831428 — AS 1740 INTERFACE MODULE
- K831429 — AS 191 ECG TELEMETRY MODULE
- K831574 — BLOOD GAS QUALITY CONTROL SOFT-86000F
- K831766 — MICROSTAR VCI
- K831987 — EPSILON IGE TEST KIT
- K832136 — DUAL FLOW NEEDLE
- K832141 — MICROSTAR VC1 VOLUMETRIC CYCLER
- K832189 — HEMOCHRON THROMBOCHRONOMETER
- K832196 — SHERIDAN/LEVI-A-SUMP
- K832212 — PATIENT SELECTOR FUNCTION BLOCK
- K832230 — DIALYZER PREPARATION SYS DPS-4
- K832360 — ABBOTT IGE EIA
- K832361 — CONCEPT T-TUBE
- K832362 — DONALDSON-TYPE VENT TUBE
- K832375 — LIQUID CHROMATOGRAPH 1090 SERIES
- K832427 — EASYTOUCH TROMBOPLASTIN REAGENT
- K832450 — URO-TEX MALE EXTERNAL CATHETER
- K832498 — PERCUTANEOUS TRACHEOSTOMY DEVICE
- K832515 — CEFUROXIME 30 MCG SENSI-DISC
- K832517 — CUSTOM KWIK SET AND/OR PAK
- K832546 — MARK V HIGH VOLTAGE GALVANIC STIMULATORR
- K832590 — MOUTH-TO-MOUTH SHIELD APPLICATOR
- K832621 — TOP DISPOSABLE PLASTIC SYRINGES
- K832622 — WINGED INFUSION SET
- K832623 — TOP DISPOS. INFUSION SET/HEMODIALY
- K832626 — TOP STERILE DISPOS. HYPODERMIC NEEDLES
- K832636 — FRAZIER SUCTION INSTRUMENT-DISPOS
- K832653 — CEFUROXIME 30MCG. SUSCEP DISK
- K832666 — NEPHROSS PRESTO
- K832680 — MICRO-EDGE DISPOSABLE BLADES
- K832686 — MULTIPLE MANUAL SURGICAL INSTRUMENTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.