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
144553–144576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 1986
EM STRESS ELECTRODE
K860827 · DRX
Electromed Intl., Ltd.
Cardiovascular · 64d
Cleared May 08, 1986
EXER-STIM 2
K861501 · GZJ
Th Charters, Inc.
Neurology · 15d
Cleared May 08, 1986
SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS
K861533 · FTC
Sunfit, Inc.
General & Plastic Surgery · 14d
Cleared May 08, 1986
COT, FOLDING HOSPITAL ALUMINUM - MANUAL BED
K861678 · FNJ
Sierra Corp.
General Hospital · 7d
Cleared May 07, 1986
DJ UNIPOLAR
K853566 · DTB
Biotronik Sales, Inc.
Cardiovascular · 254d
Cleared May 07, 1986
DJP UNIPOLAR
K853567 · DTB
Biotronik Sales, Inc.
Cardiovascular · 254d
Cleared May 07, 1986
MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901
K853754 · LHO
Victoreen, Inc.
Radiology · 240d
Cleared May 07, 1986
DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE
K853996 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 219d
Cleared May 07, 1986
MEADOX MEDICALS INC. GRAFT SIZER
K854431 · DSY
Meadox Medicals, Div. Boston...
Cardiovascular · 183d
Cleared May 07, 1986
TDK ECG ELECTRODE MEL-08-09 & -11
K854596 · DRS
Tdk Corp.
Cardiovascular · 170d
Cleared May 07, 1986
PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A
K854840 · DPS
Ivy Biomedical Systems, Inc.
Cardiovascular · 154d
Cleared May 07, 1986
RMI RESPIRATORY GATING SYSTEM MODEL 301
K854976 · IXO
Radiation Measurements, Inc.
Radiology · 146d
Cleared May 07, 1986
MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR
K860025 · KPR
Medicor USA , Ltd.
Radiology · 124d
Cleared May 07, 1986
MULTI PURPOSE MODEL 76-903
K860260 · LHO
Victoreen, Inc.
Radiology · 103d
Cleared May 07, 1986
KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT
K860427 · DSP
Kontron Instruments, Inc.
Cardiovascular · 92d
Cleared May 07, 1986
PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS
K860586 · GKL
Diagnostic Technology, Inc.
Hematology · 77d
Cleared May 07, 1986
EMIT COLUMN DIGOXIN CALIBRATORS
K861395 · DLJ
Syva Co.
Chemistry · 23d
Cleared May 06, 1986
PREMIE T.D.S. ELECTROSURGICAL GROUNDING PAD
K855084 · GEI
Conmedcorp
General & Plastic Surgery · 138d
Cleared May 06, 1986
BIOTEL (TM)/ KIDNEY
K855237 · KHE
American Diagnostic Corp.
Hematology · 126d
Cleared May 06, 1986
MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT
K860277 · EWG
Britt Corp., Inc.
Ear, Nose, Throat · 99d
Cleared May 06, 1986
NEWPORT VENTILATOR MODEL E-100
K860438 · CBK
Newport Medical Instruments, Inc.
Anesthesiology · 91d
Cleared May 06, 1986
PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259
K860442 · LPH
Howmedica Corp.
Orthopedic · 91d
Cleared May 06, 1986
STREAM LINE* I.V. CATHETER PLACEMENT UNIT
K860474 · FOZ
Menlo Care, Inc.
General Hospital · 88d
Cleared May 06, 1986
U - STAR (MICRO-STAR)
K860703 · LHI
Corning Costar Corp.
General Hospital · 69d