FDA 510(k) clearances — page 1389
clearances on record, most recent first.
Clearances — page 1389
138,801–138,900 of 175,890- K872043 — CHURCHILL INTER-CARDIAC SUCKER
- K872068 — HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD
- K872166 — FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT
- K872241 — LIFESCOPE 12, BSM 8500A PATIENT MONITOR
- K872346 — SURE-STREP A TEST KIT CATALOG NO. MB-1083
- K872596 — TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30
- K872652 — UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
- K872719 — EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER
- K873157 — OXFORD RETRO-ILLUMINATION CATARACT CAMERA
- K873178 — URETERAL BULB DILATORS
- K873206 — MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE
- K873394 — OVAL PULL-APART SHEATH/DILATOR
- K873591 — A.R.M. (ASPEN RETURN MONITOR)
- K873608 — TENS LEAD
- K873685 — NONPRESCRIPTION SUNGLASSES
- K873744 — LEUKOCLIP(R)
- K870967 — ADMS TRANSRECTAL 7.5 MHZ PROBE
- K871180 — ARTHRO AUTOMAT 5002
- K871181 — ARTHROCOMBI 5003
- K871759 — G-GT STANDARD CALIBRATOR
- K872836 — SPINOSCOPE
- K872852 — EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST
- K872961 — QTEST STREP
- K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
- K873186 — LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
- K873210 — TELSTAR MODEL PP
- K873318 — SABOUR DEXTR W/CHLORAMPHEN/GENTAM SD W/C&G AGAR PL
- K873319 — SABOURAUD DEXTROSE (SD) W/CHLORAMP AGAR PLATE
- K873320 — SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD
- K873321 — SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300
- K873322 — SABOUR DEXTR SD AGAR SLNT TUBE W/CHLORAMP #T3088
- K873350 — EASY-TEST EMIT PROCAINAMIDE (PROC) #16648
- K873354 — QBC VENOUS BLOOD CONTROL/MULTIPLE
- K873467 — QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
- K873468 — CUSTOM IN-THE-EAR HEARING AID SERIES MCA20
- K873515 — UTERINE INJECTOR 2MM
- K873548 — OPTI-ZYME(R)
- K873560 — U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID
- K873594 — TIF FECAL TEST
- K873638 — MICRO-CHEM ANALYZER
- K873678 — SPECTROPHOTOMETER (MICROASSAY PLATE READERS)
- K873681 — ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95
- K863155 — UNIVERSAL JET VENTILATOR MODEL AMS-1000
- K871416 — AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER
- K871506 — ACUSON L538 TRANSDUCER
- K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC
- K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC
- K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC
- K872711 — MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY
- K872849 — SPERM-SELECT ADDITIONAL INDICATION
- K873043 — MOUTH TO FACE RESUSCITATOR
- K873691 — CEDAR(TM) RETRACTOR RING
- K862970 — TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
- K871711 — MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM
- K871970 — DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2
- K872291 — ESCORT PORTABLE PATIENT MONITOR
- K872508 — MODEL MICRO FD+ AMBULATORY ECG MONITOR
- K872788 — MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN
- K873035 — VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER
- K873114 — CYTOMEGALOVIRUS CONTROL SLIDES
- K873170 — ARIES
- K873400 — PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA
- K873430 — FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12
- K873462 — VAN DELLEN ASPIRATOR
- K871369 — VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:
- K872654 — INTELECT MODEL 575
- K872710 — MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT
- K872762 — TORAY ANTHRON AORTA BYPASS TUBES
- K872911 — CYBEX 340
- K872936 — 97-D EMERSON DIMMER CONTROL
- K872937 — 97-TD EMERSON TIMER/DIMMER CONTROL
- K873290 — LACERATION AND INSTRUMENT TRAYS
- K873478 — SKYTRON MODEL 130 SURGICAL TABLE
- K873493 — NINJA SCALPEL
- K873514 — JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS
- K872526 — CT PACE CATALOG NUMBER B7950A
- K872615 — IMATRON C-100 ULTRAFAST CT SCANNER
- K872720 — SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET
- K872721 — EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR
- K872722 — EXPANDED USE FOR SHILEY 3L CARDF PLUS
- K872794 — MEDIX BIOTECH APOLIPOPROTEIN A-I TEST KIT
- K873078 — NOVAMETRIX MODEL 505 PULSE OXIMETER
- K873216 — BRAIN HEART INFUS AGAR SLANT W/10% SHEEP BLOOD C&C
- K873217 — BRAIN HEART INFUSION BROTH 10 ML - PRODUCT #T3006
- K873218 — BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802
- K873219 — BRAIN HEART INFUSION BROTH 0.5 ML - PRODUCT #T3583
- K873220 — BRAIN HEART INFUSION BROTH 4.5 ML - PRODUCT #T3003
- K873221 — BRAIN HEART INFUSION AGAR W/5% SB - PRODUCT #P3409
- K873222 — BRAIN HEART INFUSION BROTH W/X AND V - #T4540
- K873223 — MACCONKEY AGAR - PRODUCT #P1606
- K873224 — BRAIN HEART INFUS AGAR W/5% SB & GENTAMICIN-#P3772
- K873225 — EOSIN METHYLENE BLUE AGAR (EMB) - PRODUCT #P1309
- K873226 — XYLOSE LYSINE DEOXYCHOLATE AGAR - PRODUCT #P3601
- K873227 — MANNITOL SALT AGAR (MSA) PRODUCT #P1706
- K873228 — LEVINE EOSIN METHYLENE BLUE AGAR (LEMB) - #P1507
- K873401 — TURBOX
- K873406 — RRT SHORT RAGWEED TEST KIT
- K873407 — RRT SYSTEM LASER REFLECTOMETER ANALYZER
- K873458 — HOWMEDICA PCA COLLARED FEMORAL STEM
- K873542 — MICROPLATE AUTO-WASHER (MOTORIZED STAGE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.