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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
156289–156312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 1983
EPA AUTOMATED INFUSION POLE
K832997 · HQC
Miami Eye Technology, Inc.
Ophthalmic · 32d
Cleared Oct 04, 1983
SUMMA DISK
K833038 · DZP
Shofu Dental Corp.
Dental · 28d
Cleared Oct 04, 1983
HANDY IIM
K833039 · EJP
Shofu Dental Corp.
Dental · 28d
Cleared Sep 29, 1983
PZ-800 VOLUME VENTILATOR
K822835 · CBK
Narco Scientific
Anesthesiology · 373d
Cleared Sep 29, 1983
MMS ACETABULAR CUPS
K830361 · JDI
3M Company
Orthopedic · 238d
Cleared Sep 29, 1983
ELASTOPLAST T.P.N.
K831439 · FPX
Beiersdorf, Inc.
General & Plastic Surgery · 147d
Cleared Sep 29, 1983
DOSIMETRY RELEASE OF RADIATION STERILIZ
K831512 · JDK
Biomet, Inc.
Orthopedic · 140d
Cleared Sep 29, 1983
H-FLU B ELISA TEST
K831525 · GRP
Seragen Diagnostics, Inc.
Microbiology · 140d
Cleared Sep 29, 1983
BIOCHECK PEC-108 PROGRAM-PULSE MONITOR
K831752 · DRT
Biotechnology, Inc.
Cardiovascular · 120d
Cleared Sep 29, 1983
ANSPACH 65,000
K831756 · HSZ
The Anspach Effort, Inc.
Orthopedic · 120d
Cleared Sep 29, 1983
PATIENT MONITOR #78353A
K831787 · DRT
Hewlett-Packard Co.
Cardiovascular · 118d
Cleared Sep 29, 1983
CARDIO-SCOPE MINI MONITOR
K831878 · DPS
W.E. Leder Enterprises, Inc.
Cardiovascular · 108d
Cleared Sep 29, 1983
BASIC BREAST PUMP
K831929 · HGY
Terayco Intl., Ltd.
Obstetrics & Gynecology · 106d
Cleared Sep 29, 1983
LARYNGESCOPE
K831981 · CCW
W.E. Leder Enterprises, Inc.
Anesthesiology · 101d
Cleared Sep 29, 1983
FEMORAL CANAL SUCTION TAMPON
K831999 · JOL
Richards Manufacturer Co.
General Hospital · 100d
Cleared Sep 29, 1983
HEPARIN COATED STAINLESS STEEL/TEFLON
K832030 · DOX
Argon Medical Corp.
Toxicology · 98d
Cleared Sep 29, 1983
STERILE FLUID PRODUCING UNIT #EP550
K832040 · LJH
American Cystocope Makers, Inc.
Gastroenterology & Urology · 97d
Cleared Sep 29, 1983
SHILEY MULTIPRO CATHETER
K832044 · DXE
Shiley, Inc.
Cardiovascular · 97d
Cleared Sep 29, 1983
SINGLE PATIENT SYS. II MODEL DM-450
K832053 · KOC
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 94d
Cleared Sep 29, 1983
CONTROL 282
K832066 · JKS
Bio-Nustics, Inc.
Chemistry · 94d
Cleared Sep 29, 1983
MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT
K832077 · LJP
Syva Co.
Microbiology · 93d
Cleared Sep 29, 1983
MICRO TRAK CHLAMYDIA TRAC CONTROL SLID
K832078 · LJP
Syva Co.
Microbiology · 93d
Cleared Sep 29, 1983
COLLECTION KIT CHLAMYDIA TRACHOMATIS
K832079 · LIO
Syva Co.
Microbiology · 93d
Cleared Sep 29, 1983
REXTON RX10, RX20-30 & 40
K832180 · ESD
Rexton, Inc.
Ear, Nose, Throat · 85d