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
137953–137976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 1987
PLASTER VACUUM, 115V MODEL NO. 4183-160
K873721 · LGH
Martin Medical
Orthopedic · 83d
Cleared Dec 07, 1987
CORMED III AMBULATORY INFUSION PUMP
K873847 · FRN
C.R. Bard, Inc.
General Hospital · 76d
Cleared Dec 07, 1987
AEROSOL DELIVERY SYSTEM (AERO-TECH II)
K873930 · CAF
Cadema Medical Products, Inc.
Radiology · 73d
Cleared Dec 07, 1987
NEW C-D SYSTEM FOR SPINAL SURGERY
K873977 · JDN
Sofamor Co.
Orthopedic · 69d
Cleared Dec 07, 1987
H.T.U. (HYPERBARIC THERAPY UNIT)
K874107 · CBF
Hyox Systems C/O Mechidyne Systems, Inc.
Anesthesiology · 59d
Cleared Dec 07, 1987
TITANIUM BONE SCREWS
K874130 · HWC
Orthopedic Systems, Inc.
Orthopedic · 55d
Cleared Dec 07, 1987
GUIDE WIRE
K874164 · EZB
Endovations
Gastroenterology & Urology · 55d
Cleared Dec 07, 1987
MEDTRONIC PERMANENT LEAD INTRODUCER
K874167 · DTB
Medtronic Vascular
Cardiovascular · 55d
Cleared Dec 07, 1987
MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY
K874238 · EHD
Belmont Equipment Corp.
Radiology · 53d
Cleared Dec 07, 1987
JEHLE CORONARY PERFUSION CATHETERS
K874242 · KRA
Pilling Co.
Cardiovascular · 52d
Cleared Dec 07, 1987
TRICHOMONAS DIRECT ENZYME IMMUNOASSAY
K874259 · JWZ
California Integrated Diagnostics, Inc.
Microbiology · 48d
Cleared Dec 07, 1987
URETHAL CATHETER
K874309 · KNX
Medovations, Inc.
Gastroenterology & Urology · 48d
Cleared Dec 07, 1987
WILSON-COOK BIOPSY FORCEPS
K874314 · KNW
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 48d
Cleared Dec 07, 1987
ENTERAL FEEDING TUBE
K874393 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 40d
Cleared Dec 07, 1987
RESUBMITTED STANDARD MICROPORE ECG ELECTRODE
K874628 · DRX
Labeltape Meditect, Inc.
Cardiovascular · 46d
Cleared Dec 04, 1987
COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION
K872576 · GQH
Enzo Biochem, Inc.
Microbiology · 157d
Cleared Dec 04, 1987
DGH-3000A A-SCAN
K872726 · IYO
Dgh Technology, Inc.
Radiology · 149d
Cleared Dec 04, 1987
STRUNG DENTAL ROLLS
K872810 · EFN
American Silk Sutures, Inc.
Dental · 143d
Cleared Dec 04, 1987
LEWIS SAFE SLEEVE
K873960 · EIF
Cheri Lewis, D.D.S.
Dental · 67d
Cleared Dec 04, 1987
ENTERON ABDOMINAL PARACENTESIS TRAY
K874063 · KDD
Endovations
General & Plastic Surgery · 60d
Cleared Dec 04, 1987
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K874131 · CIC
Pointe Scientific, Inc.,
Chemistry · 52d
Cleared Dec 04, 1987
MODIFIED USE OF TRIANGLE BANDAGE STERILE
K874161 · NAD
K. W. Griffen Co.
General & Plastic Surgery · 52d
Cleared Dec 04, 1987
BIOTIS (TM) STARCH HYDROLYSIS WITH BCP
K874174 · JSF
Otisville Biopharm, Inc.
Microbiology · 52d
Cleared Dec 04, 1987
BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC
K874175 · JSF
Otisville Biopharm, Inc.
Microbiology · 52d