FDA 510(k) clearances — page 1571
clearances on record, most recent first.
Clearances — page 1571
157,001–157,100 of 175,890- K831258 — FLO-GARD 6100 VOLUMETRIC INFUSION PUMP
- K831295 — AMYLASE REAGENT #88129
- K831332 — ARGYLE DUAL STAGE VENOUS RETURN CATH.
- K831371 — MODEL FM5
- K831380 — DELTON LIGHT CURING PIT & FISSURE
- K831409 — HAEMOLYTE SOLUTION
- K831431 — AUDIOMETER MODEL-500
- K831434 — ISO-SEP SYSTEM
- K831456 — TOXI-LAB CANNABINOID THC SCREEN
- K831459 — FETAL BLOOD SAMPLING KIT #1560
- K831492 — YESONA PLASTER OF PARIS BANDAGE
- K831493 — DENTURE ADHESIVE SEALS
- K831500 — TRI-LEVEL TDM CONTROL & I II III
- K831514 — AMWA TDA THEOPHYLLINE TEST
- K831515 — DINAMAP VITAL SIGNS MONITOR #1846
- K831528 — MODEL TP THERMISTOR PROBE
- K831529 — CCS MODEL SJ-103 IMPLANTABLE ATRIAL
- K831533 — MAGIC T4 125I RADIOIMMUNOASSAY
- K831535 — E.P.T. PLUS TM
- K831549 — ARM SLINGS
- K831559 — CERTAIN *DENTAL RESTORATIVE
- K831562 — SONTEK INFUSION CATHETER
- K831563 — CORONARY GUIDING CATHETER-MODIFIED
- K831568 — RELIANCE TEMPO OPHTH. INSTR STAND
- K831569 — REAGENT CUPS
- K831571 — ROTOR
- K831575 — NU-CAP CALCIUM HYDROX. PULP CAPPING
- K831591 — AORTIC ROOT CANNULA W/INTEGRAL PRESS
- K831597 — SERO/TEX RED CELL RF TEST
- K831605 — HEMATOLOGY PAK
- K831637 — ACCU-FLUSH
- K831647 — DENTURE RELINING, REPAIR/REBASING RESIN
- K831656 — ARTHROSCOPY KNIVES/PROBES/BENDING TOOL
- K831673 — OXY-SWAB
- K831674 — RIM-CAMP TEST
- K831675 — TWIST LOCK DRILL 1120
- K831691 — PRIVATE LABEL DEODORANT MAXISHIELD
- K831702 — RARE-EARTH INTRA-OCULAR MAGNET
- K831709 — AUDIOSCOPE #23000 W/71123 CHARGING STAND
- K831717 — CORONARY INFUSION CATHETER
- K831747 — PLASMA THERAPY TUBESET-E100 SERIES
- K831785 — NEURO EASE
- K831831 — TRULIFE SILICONE BREAST FORM
- K831836 — EPSILON ULTRASONIC TIP
- K831806 — SUTURE KITS STERILIZED W/GAMA RADIATION
- K837355 — UNKNOWN
- K837412 — SATURNE I LINEAR ACCELERATOR
- K837465 — ALCYON ROTATIONAL COBALT THERAPY
- K837515 — DENTAL CASSETTE HOLDERS
- K837573 — SHARPLAN LASER POSITIONING SYSTEM
- K837605 — MV/CM2 NUMBER X74294 MODEL NUMBER 74229
- K831548 — SPLINTS
- K837608 — PIP X-RAY PROTECTIVE GLASSES
- K823912 — AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
- K823917 — PARTIAL OSSICULAR REPLACEMENT
- K823918 — AUSTIN MODIFIED PARTIAL OSSICULAR RE-
- K823919 — TOTAL OSSICULAR REPLACEMENT
- K830270 — ISOVIS WOUND PROTECTOR
- K830314 — MILWAUKEE AUSTIN MOORE TOTAL HIP
- K831002 — TPG 1000
- K831041 — SAGITTAL KNEE TESTER
- K831044 — LIMITED MOTION FUNCTIONAL KNEE BRACE
- K831078 — STRAITH ORAL AIRWAY
- K831135 — SAUNDERS #7080 CERVICAL TRACTION SYS
- K831198 — CPR HEARTSAVER AND BREATHOLATOR
- K831248 — PATELLAR FAT PAD RETRACTOR
- K831372 — TLS SURGICAL MARKER
- K831497 — SPIROMETRICS BREON 2400 & SMI 2400
- K831508 — MALIS CMC-II BIPOLAR COAGULATOR & CUT
- K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE
- K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK
- K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035
- K831550 — FINGER BONIOMETER BK7506
- K831606 — GF-180-L HOLLOW FIBER HEMODIALYSIS
- K831678 — P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR
- K831690 — IPOS ANTI-ADDUCTUS SHOE
- K831706 — SATO FAMILY FIRST AID KIT
- K831716 — CAPD - CATHETER ADAPTER
- K831762 — SITZ BATH, SINGLE PATIENT USE #8100
- K837346 — MODEL GAMMACELL 1000
- K837347 — LINEAR ACCELERATOR THERAC 25
- K837481 — BF24 DOPPLER MODEL P872 AND P874
- K830726 — MARK I & II TOTAL KNEE REPLACE. SYS
- K830748 — RESUSCITAIRE
- K830791 — UNIVERSAL MEDDARS SYSTEM
- K830885 — GOULD MODEL IM3000-IM3100 BATTERY POWER
- K830953 — MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION
- K831026 — INDIRECT FLUORESCENT ANTIBODY REAGENTS
- K831075 — BLOOD GAS & FLAME PHOTOMETER INSTRU-
- K831383 — EVENT-TEST SLIDE
- K831446 — SURGITEK NEPHROSTENT KIT
- K831466 — HCG-CHECK
- K831468 — B HCG-CHECK
- K831470 — PTH MR
- K831478 — LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN
- K831480 — PARAMAX ALKALINE PHOSPHATASE REAGENT-
- K831498 — URI-TEST 3, INLAB REAGENT STRIPS-URINAL
- K831518 — AUTO CAROUSE/WASH SOLUTION CONCENTRATE
- K831519 — RPMI-1640 MEDIUM W/L-GLUTAMINE &
- K831537 — PARAMAX CREATINE KINASE REAGENT
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