Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
143689–143712 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 1986
ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT
K862019 · MSJ
Beckman Instruments, Inc.
Immunology · 51d
Cleared Jul 18, 1986
CARDIOMET 4000 GAS MONITORING SYSTEMS
K862069 · DRY
Biomedical Sensors, Inc.
Cardiovascular · 49d
Cleared Jul 18, 1986
CAMINO HAND DRILL - MODEL 030
K862160 · HBG
Camino Laboratories, Inc.
Neurology · 42d
Cleared Jul 18, 1986
PHONIC EAR, MODEL PE 1800
K862162 · ETW
Phonic Ear, Inc.
Ear, Nose, Throat · 42d
Cleared Jul 18, 1986
BETAFLO 2000
K862273 · LDR
Betaflo, Inc.
General Hospital · 32d
Cleared Jul 18, 1986
ICS APOLIPOPROTEIN B REAGENT TEST KIT
K862386 · MSJ
Beckman Instruments, Inc.
Immunology · 24d
Cleared Jul 18, 1986
LS3000 CANNULA UTERINE SUCTION
K862476 · HHI
Engineering, Inc.
Obstetrics & Gynecology · 18d
Cleared Jul 18, 1986
AUSTENAL ACUPAC HI DENTURE BASE MATERIAL
K862558 · EBI
Austenal Dental, Inc.
Dental · 15d
Cleared Jul 18, 1986
SITZ BATH
K862600 · KTC
W. C. Green, D.D.S.
Physical Medicine · 10d
Cleared Jul 18, 1986
V-BOND, PAINT-ON COMPOSITE RESTOR/VENEER CEMENT
K862648 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 7d
Cleared Jul 18, 1986
MODIFIED PENOX LIFT CHAIR
K862654 · INO
Penox Technologies, Inc.
Physical Medicine · 7d
Cleared Jul 17, 1986
HDC CHEMO-PORT (VASCULAR)
K853332 · LJT
Hdc Corp.
General Hospital · 343d
Cleared Jul 17, 1986
ANGIOFLOW
K854910 · DQO
Angiomed U.S., Inc.
Cardiovascular · 220d
Cleared Jul 17, 1986
ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR
K855101 · FRC
Surgicot, Inc.
General Hospital · 206d
Cleared Jul 17, 1986
R1618, R1619 & R1654 ICE MAKING MACHINES
K861343
Tri W-G, Inc.
Physical Medicine · 101d
Cleared Jul 17, 1986
DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET
K861390 · FMI
Baxter Healthcare Corp
General Hospital · 94d
Cleared Jul 17, 1986
DISPOSABLE STOPCOCK
K861783 · DTL
Utah Medical Products, Inc.
Cardiovascular · 70d
Cleared Jul 17, 1986
FUTUREMED ECG SYSTEM 500
K862381 · DPS
Futuremed Div. of Future Impex Corp.
Cardiovascular · 23d
Cleared Jul 17, 1986
HALL STERNUM SAW
K862474 · DWH
Hall Surgical, Division of Zimmer, Inc.
General & Plastic Surgery · 17d
Cleared Jul 17, 1986
STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1
K862510 · KRI
Shiley, Inc.
Cardiovascular · 16d
Cleared Jul 17, 1986
DISPENS-O-DISC DIFFERENTIATION DISKS PYR
K862570 · JTO
Difco Laboratories, Inc.
Microbiology · 10d
Cleared Jul 17, 1986
SURGICAL LASER ACCESSORIES (SLA) CASE
K862629 · FSM
Simpson/Basye, Inc.
General & Plastic Surgery · 7d
Cleared Jul 16, 1986
GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM
K860498 · LQH
Gen-Probe, Inc.
Microbiology · 156d
Cleared Jul 16, 1986
ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR
K860585 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 148d