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
141937–141960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1986
RNET SYSTEM, IV RECEIVING TERMINAL, TRANSMITTER
K863716
Futurecare Systems, Inc.
Cardiovascular · 90d
Cleared Dec 22, 1986
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
K863841 · LCX
Hybritech, Inc.
Chemistry · 82d
Cleared Dec 22, 1986
BINAX STREP A
K863908 · GTZ
Binax, Inc.
Microbiology · 76d
Cleared Dec 22, 1986
KENZ-ECG 102
K863965 · DXK
Compumed, Inc.
Cardiovascular · 73d
Cleared Dec 22, 1986
SPECIFIC IGE FAST(TM) TEST II
K863967 · DHB
3M Company
Immunology · 73d
Cleared Dec 22, 1986
EM TENS WINDOW ELECTRODES
K864032 · GXY
Electromed Intl., Ltd.
Neurology · 68d
Cleared Dec 22, 1986
IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS
K864409 · LER
Sclavo, Inc.
Toxicology · 42d
Cleared Dec 22, 1986
CHOICE
K864482 · HIS
Select Sources, Inc.
Obstetrics & Gynecology · 39d
Cleared Dec 22, 1986
TISSUE GRAM STAIN
K864531 · ICF
Sigma Diagnostics, Inc.
Pathology · 35d
Cleared Dec 22, 1986
FLUORESCENCE CONCENTRATION ANALYZER (FCA)
K864699 · JZT
Pandex Laboratories, Inc.
Immunology · 20d
Cleared Dec 22, 1986
BREMER HALO SYSTEM
K864746 · HAX
Bremer Orthopedics
Neurology · 17d
Cleared Dec 22, 1986
BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR
K864754
Pudenz-Schulte Medical Research Corp.
Neurology · 17d
Cleared Dec 19, 1986
OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM
K863668 · JWH
Osteonics Corp.
Orthopedic · 92d
Cleared Dec 18, 1986
OPHTHASONIC A-SCAN
K860757 · IYO
Teknar, Inc.
Radiology · 293d
Cleared Dec 18, 1986
V100 VISUALLY EVOKED POTENTIAL MONITOR
K860910 · GWE
New Potentials, Inc.
Neurology · 282d
Cleared Dec 18, 1986
LKB ULTROBACT (TM) PNEUMOCOCCUS KIT
K862848 · GWC
Lkb Instruments, Inc.
Microbiology · 142d
Cleared Dec 18, 1986
METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI.
K863492 · FAD
Surgitek
Gastroenterology & Urology · 100d
Cleared Dec 18, 1986
BUTTERFLY NON-CORING NEEDLE SET
K863606 · FMI
Cormed, Inc., Sub. C.R.Bard, Inc.
General Hospital · 93d
Cleared Dec 18, 1986
MIC - CONCEPT(TM) RX-2
K863847 · JWY
Microtech Medical Systems, Inc.
Microbiology · 79d
Cleared Dec 18, 1986
DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT
K864133 · JLW
Diagnostic Systems Laboratories, Inc.
Chemistry · 58d
Cleared Dec 18, 1986
VICRYL* POLYGLACTIN 730 ABSORBABLE STAPLES/STAPLER
K864350 · FZP
Ethicon, Inc.
General & Plastic Surgery · 44d
Cleared Dec 18, 1986
STORZ SOLID & ANGLED SOLID CONTACT PROBES
K864398 · IYO
Storz Instrument Co.
Radiology · 42d
Cleared Dec 18, 1986
MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM
K864403 · LXT
Howmedica Corp.
Orthopedic · 38d
Cleared Dec 18, 1986
MANAN CONTRAST MEDIA ADMINISTRATION SET
K864405 · FPA
Manan Manufacturing Co., Inc.
General Hospital · 38d