FDA 510(k) clearances — page 1629
clearances on record, most recent first.
Clearances — page 1629
162,801–162,900 of 175,890- K812759 — NML CK-MB RIA
- K812771 — PERITONEAL DIALYSIS DRAINAGE
- K812772 — PERITONEAL DIALYSIS CYCLER SET (8UNIT)
- K812777 — DIRECT IRON REAGENT SET
- K811951 — DRESSING CHANGE TRAYS & STERILE SPONGES
- K802342 — PROXIMAL INTERPHALANGEAL JOINT IMPLANT
- K811737 — BIO-TONE MODEL 4
- K811916 — OPERATING ROOM KIT
- K812529 — EARSCAN
- K812532 — TEMP-FILL
- K811593 — ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J
- K812199 — TROCAR & TROCAR SLEEVES
- K812203 — ELECTROSURGICAL UNIT
- K812204 — UTERINE MANIPULATORS
- K812206 — LAPAROSCOPE
- K812218 — KALOS-03
- K812281 — TOUCHLESS HOME-CATH
- K812304 — DORROS-SPRING PRESSURIZER
- K812393 — 4001 CT SCANNER
- K812446 — SUNLAMP
- K812461 — TANDEM QUALITATIVE HCG KIT
- K812502 — IMPLANTAID LEAD INTRODUCER #319-10 & 12
- K812509 — CT/T 8800
- K812517 — CARDIAC PACING ELECTRODES
- K812530 — TRANSDUCER DOME
- K812539 — PRE-BYPASS FILTER
- K812561 — LATERAL ANGULATING FLUORO SUSPENSION SYS
- K812606 — SECTORTAC
- K812616 — POLYPHOS 500
- K812674 — INFANT CARIDAC MONITOR
- K812675 — DISPOSABLE SURGICAL FACE MASKS
- K812676 — AMPLITONE-3
- K812683 — NEONATE FLEXFLOAT
- K812693 — LIF-O-GEN #3000 OXYGEN CONCENTRATOR
- K812695 — DISK
- K812701 — ORTHO-THERM INFRARED SENSOR
- K812715 — TECA #TE 8
- K812723 — PEARCE CORNEAL TREPHINE
- K812560 — MDM ARTERIAL BLOOD GAS SYRINGE
- K812835 — TOTAL CALCIUM REAGENT SET
- K812836 — LDH REAGENT SET
- K812155 — MEDTRONIC DUAL CHANNEL SPINAL CORD STIM
- K812426 — UTERINE ASPIRATION CURETTES(RIGID&FLEX)
- K812543 — TANARAMA
- K812579 — SUNTANNING HOME UNIT
- K812619 — ISOLATED VOLTAGE/FREQUENCY CONVERTER
- K812627 — ACA ANTITHROMBIN III TEST PACK
- K812629 — ACA FIBRINOGEN TEST PACK
- K812656 — DOTRICH ELECTRONIC AIR CLEANER #C500AM
- K812672 — SELF-CENTERING HIP
- K812681 — ADULT FLEX FLOAT W/HEATER
- K812682 — FLEXFLOAT HEATER
- K812684 — ADULT FLEXFLOAT
- K812697 — HEMA 20 MICRON TRANSFUSION BLOOD FILTER
- K812052 — MYOCATH CATOLOG NO. MCK-A
- K812073 — DESERET CATHETER DRESSING
- K812221 — INTERMEDICS POLY FLEX EPICARDIAL SUTURE
- K812245 — INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL
- K812406 — EXAFLEX IMPRESSION MATERIAL
- K812441 — DI-CROWN
- K812571 — MEZLOCILLIN 75 MCG. SENSI-DISC
- K812587 — MONO 2 OXYGEN MONITOR
- K812679 — G-C FIT-CHECKER IMPRESSION MATERIAL
- K812680 — G-C IMPRESSION SYRINGE
- K812689 — RIA QUANT C-PEPTIDE KIT
- K812690 — C-PEPTIDE CONTROL PACK
- K812698 — GC DISK
- K812699 — AMYLASE
- K812719 — PROSANA BELT
- K812176 — KORICLEAN
- K811867 — SR-ALGICAP
- K812019 — LOXLEY EMERGENCY CERVICAL COLLAR
- K812124 — MLA ELECTRA 700
- K812286 — MINITECK ENTERIC BROTH & ENTEROBACTER
- K812337 — ISOCENTRIC NEUTRON THERAPY SYSTEMS
- K812400 — OMNIMEDICAL QUAD I
- K812410 — DELTASCAN 2060 CT SCANNER
- K812424 — CI-TROL HEPARIN CONTROLS, LOW/HIGH
- K812448 — UNI-THANE
- K812501 — OPRAFLEX
- K812515 — CARDIAC REVIEW STATION
- K812516 — SURGICAL BLADES & SCAPELS (SMPL. W/510K)
- K812521 — SUNTANNING DEVICE (SEPAR. FROM K812225)
- K812525 — MEZLOCILLIN 75 MCG. SENSITIVITY DISCS
- K812562 — SURGICAL RETRACTOR & ELASTIC STAYS, DISP
- K812570 — LABCER FIBRINOGEN ASSAY KIT & CALIBR.
- K812578 — ELEGANCE
- K812593 — ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
- K812594 — ULTRA ZYME PLUS AMYL #64982 & 65031
- K812601 — SQC BUFFER
- K812604 — BIOVATION URINALYSIS REPORTER
- K812605 — FIBER OPTIC LIGHT SOURCE I
- K812607 — TENCKHOFF PERITONEAL CATHETERS
- K812608 — VASCULAB #R12B
- K812609 — VASCULAB #VSC21
- K812611 — QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO
- K812617 — VITROGEN TM 100
- K812618 — ASSURE NATURAL FIT TAMPON
- K812635 — ANEMIA CONTROL
- K812639 — UNICUFF
Data sourced from openFDA. This site is unofficial and independent of the FDA.