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
144841–144864 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1986
VAPORIZER SPACER
K860545 · CAD
Southmedic, Inc.
Anesthesiology · 63d
Cleared Apr 17, 1986
PERITONE DISPOSAL SHEATH - RUBBER AND VINYL
K860552 · HIR
Laurie Ann Kaiser, Ph.D.
Gastroenterology & Urology · 62d
Cleared Apr 17, 1986
ES600 IMMUNOASSAY SYSTEM
K860647 · JJE
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Apr 17, 1986
PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT
K860653 · DZE
Otc/America
Dental · 55d
Cleared Apr 17, 1986
END TIDAL CO2 SAMPLING CIRCUIT
K860659 · BZO
Life Design Systems, Inc.
Anesthesiology · 52d
Cleared Apr 17, 1986
PHOTO CLEARFIL OPAQUER
K860708 · EBF
Kuraray Co.
Dental · 50d
Cleared Apr 17, 1986
FISCHER IMAGING FX325R X-RAY GENERATOR
K860736 · IZO
Fischer Imaging Corp.
Radiology · 49d
Cleared Apr 17, 1986
HITACHI 736
K860748 · JJE
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Apr 17, 1986
LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35
K860822 · FAJ
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 44d
Cleared Apr 17, 1986
EPIDURAL ANESTHESIA TRAY
K860833 · CAZ
Travenol Laboratories, S.A.
Anesthesiology · 43d
Cleared Apr 17, 1986
MALLORY/HEAD - PF ACETABULAR COMPONENT
K861114 · JDI
Biomet, Inc.
Orthopedic · 23d
Cleared Apr 17, 1986
ORTHOMED ORTHOPAEDIC FIXATION STAPLES
K861137 · JDR
Biomedical Exports, Inc.
Orthopedic · 22d
Cleared Apr 17, 1986
GAUZE SPONGES USP TYPE VII
K861215 · EFQ
Selomas, Inc.
General & Plastic Surgery · 17d
Cleared Apr 17, 1986
ACRYLIC SOLDER
K861239 · EBI
Parker Laboratories, Inc.
Dental · 15d
Cleared Apr 17, 1986
AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N
K861251 · KNX
American Medical Products, Inc.
Gastroenterology & Urology · 15d
Cleared Apr 17, 1986
PERMABAND (ORTHODONTIC ADHESIVE)
K861258 · DYH
Ortho Source
Dental · 14d
Cleared Apr 17, 1986
SKIN MESH DEVICE
K861285 · GFD
Precision Modified Devices
General & Plastic Surgery · 10d
Cleared Apr 16, 1986
BOTTOMS-UP TM PELVIC SPINAL POSTURE-AID
K854710 · KNN
Reloke Co.
Physical Medicine · 146d
Cleared Apr 16, 1986
ANGIOMED GUIED WIRES
K854912 · DQX
Angiomed U.S., Inc.
Cardiovascular · 128d
Cleared Apr 16, 1986
PMS PERCUTANEOUS PUNCTURE NEEDLE
K854941 · DYB
Professional Medical Services
Cardiovascular · 127d
Cleared Apr 16, 1986
DURAHESIVE PROTECTIVE BARRIER WIPE
K855019 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 121d
Cleared Apr 16, 1986
CURITY PERCUTANEOUS CATHETER INSERTION TRAY
K855060 · DYB
The Kendal Co.
Cardiovascular · 119d
Cleared Apr 16, 1986
CURITY PERCUTANEOUS CATHETER INSERTION KIT
K855061 · DYB
The Kendal Co.
Cardiovascular · 119d
Cleared Apr 16, 1986
37-701-1 PATIENT DOASE MONITOR WITH DETECTORS
K860469 · KPZ
Victoreen, Inc.
Radiology · 69d