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
147985–148008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 25, 1985
SAVARY-GILLIARD DILATOR
K851955 · KNQ
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Jul 25, 1985
ROTATABLE POLYPECTOMY SNARE POS-1
K851958 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 83d
Cleared Jul 25, 1985
FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40
K852251 · KDI
Seratronics, Inc.
Gastroenterology & Urology · 63d
Cleared Jul 25, 1985
MODEL SA3 ESOPHAGEAL PH ELECTRODE
K852289 · FFT
World Precision Instruments, Inc.
Gastroenterology & Urology · 57d
Cleared Jul 25, 1985
HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.
K852464 · HQF
Hcg, Inc.
Ophthalmic · 45d
Cleared Jul 25, 1985
ETCH AND BOND
K852660 · KLE
Dentsply Intl.
Dental · 31d
Cleared Jul 25, 1985
ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251
K853017 · DXY
Ela Medical, Inc.
Cardiovascular · 8d
Cleared Jul 25, 1985
#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ
K853034 · DXY
Intermedics, Inc.
Cardiovascular · 7d
Cleared Jul 24, 1985
HIGH PRESSURE FLEX. CONNECTING TUBING
K841092 · DXT
Tronomed, Inc.
Cardiovascular · 498d
Cleared Jul 24, 1985
HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA
K844484 · KRG
Vitatron Medical BV
Cardiovascular · 247d
Cleared Jul 24, 1985
NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG
K844810 · KNX
C.R. Bard, Inc.
Gastroenterology & Urology · 225d
Cleared Jul 24, 1985
COACH TM- THE AEROBIC FITNESS MONITOR
K851335 · DRT
Biotechnology, Inc.
Cardiovascular · 112d
Cleared Jul 24, 1985
ECG MONITOR MODEL RM102
K851496 · DXJ
Honeywell, Inc.
Cardiovascular · 100d
Cleared Jul 24, 1985
DISPOSABLE PLASTIC SYRINGES
K851523 · FMF
Transcoject GmbH & Co. KG
General Hospital · 99d
Cleared Jul 24, 1985
MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO
K851664 · DXN
Sharp Electronics Corp.
Cardiovascular · 92d
Cleared Jul 24, 1985
THE HENLEY BOARD S.I.D. SPINAL IMMOBILIZATION DEVI
K852100 · FPD
Henley Board, Inc.
Gastroenterology & Urology · 70d
Cleared Jul 24, 1985
LYPHOCHEK DRUG FREE SERUM(HUMAN)
K852414 · DIF
Bio-Rad
Toxicology · 48d
Cleared Jul 24, 1985
SUNBEAM DENTAL CARE CENTER, MODEL NO. 6273
K852593 · EFS
Northern Electric Co. Div. of Sunbeam...
Dental · 35d
Cleared Jul 24, 1985
ETEN-GEL
K852658 · EBF
Dentsply Intl.
Dental · 30d
Cleared Jul 24, 1985
XEN-REX I
K852693 · IYT
Nuclear Pharmacy, Inc.
Radiology · 28d
Cleared Jul 24, 1985
RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
K852841 · GTZ
Smithkline Diagnostics, Inc.
Microbiology · 19d
Cleared Jul 24, 1985
AM FAB SIDE RAILS MODEL 5000
K852890 · FNJ
Am Fab, Inc.
General Hospital · 15d
Cleared Jul 24, 1985
TOSHIBA DIGITAL CLINICAL THERMOMTER
K852903 · FLL
Toshiba Medical Systems
General Hospital · 15d
Cleared Jul 23, 1985
R PAK
K851203 · LFL
CooperVision, Inc.
General & Plastic Surgery · 119d