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
138169–138192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 17, 1987
EDENTEC MULTI-CHANNEL RECORDER
K873081 · DQA
Edentec Corp.
Anesthesiology · 104d
Cleared Nov 17, 1987
HYPERTHERM TECHNOLOGIES' HEAT COMPRESS
K873364 · IMD
Hypertherm Technologies, Inc.
Physical Medicine · 88d
Cleared Nov 17, 1987
STAINLESS 22-13-5 SUTURE WIRE
K873645 · GAQ
Zimmer, Inc.
General & Plastic Surgery · 70d
Cleared Nov 17, 1987
COMFEEL ULCUS ULCER CARE SYSTEM
K873669 · FRO
Coloplast A/S
General & Plastic Surgery · 67d
Cleared Nov 17, 1987
SELECT SHOULDER SYSTEM
K873679 · HSD
Intermedics Orthopedics
Orthopedic · 64d
Cleared Nov 17, 1987
POIRIER KID-ROLLER MANUAL WHEELCHAIR
K874317 · IOR
Roseburg SA
Physical Medicine · 27d
Cleared Nov 17, 1987
PLASTIC TUBING CONNECTOR
K874360 · FPK
American Medical Technology, Inc.
General Hospital · 25d
Cleared Nov 16, 1987
ABCOM 1 CARDIAC OUTPUT MONITOR
K870857 · JOP
Applied Biometrics, Inc.
Cardiovascular · 258d
Cleared Nov 16, 1987
MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE
K871579 · HHR
Sharplan Lasers, Inc.
Obstetrics & Gynecology · 207d
Cleared Nov 16, 1987
FETAL SCALP ELECTRODE
K872057 · HGP
Medical Accessories, Inc.
Obstetrics & Gynecology · 172d
Cleared Nov 16, 1987
INSUFFLATOR TUBING
K872860 · HIG
Medline Industries, Inc.
Obstetrics & Gynecology · 118d
Cleared Nov 16, 1987
TECA/MEDELEC TTT THERMAL THRESHOLD TESTER
K872931 · LLN
Teca, Inc.
Neurology · 112d
Cleared Nov 16, 1987
OXYGEN/STERILE AIR GEN SYST/SURGICAL HANDPIECES
K873284 · CAW
Litton Systems, Inc.
Anesthesiology · 91d
Cleared Nov 16, 1987
STEREOTIX
K873618 · IZH
Thomson-Cgr Medical Corp.
Radiology · 69d
Cleared Nov 16, 1987
CHROME-COBALT BASE DENTAL ALLOY
K873661 · EJH
North American Alloys, Inc.
Dental · 67d
Cleared Nov 16, 1987
CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL)
K873683 · EBF
Pentron Corp.
Dental · 63d
Cleared Nov 16, 1987
OMNI DIAGNOST
K874113 · IXR
Xre Corp.
Radiology · 38d
Cleared Nov 16, 1987
TRAUMA TABLE II
K874114 · IXR
Xre Corp.
Radiology · 38d
Cleared Nov 16, 1987
MODEL A-17, BEHIND-THE-EAR HEARING AID
K874324 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 26d
Cleared Nov 13, 1987
MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS
K872039 · EAT
Life-Tech Intl., Inc.
Dental · 170d
Cleared Nov 13, 1987
CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)
K872145 · GKL
Cryo Corp.
Pathology · 162d
Cleared Nov 13, 1987
INFUSE-A-PORT ADDITIONAL SIZES
K872329 · LJT
Shiley Infusaid, Inc.
General Hospital · 149d
Cleared Nov 13, 1987
IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE)
K873287 · KOD
Todd Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 13, 1987
KEELER CTU CRYO SYSTEM
K873388 · HPS
Keeler Instruments, Inc.
Ophthalmic · 81d