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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
171865–171888 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1978
X-RAY UNIT, PORTABLE GX-101 AEC
K781030 · IZL
General X-Ray, Inc.
Radiology · 28d
Cleared Jul 17, 1978
EMISONIC 4201
K781051 · IYO
Emi Medical, Inc.
Radiology · 25d
Cleared Jul 17, 1978
FACE TENTS
K781055 · BYG
Hospitak, Inc.
Anesthesiology · 24d
Cleared Jul 17, 1978
CLINAC 20 (OPTIONAL 18 MV VERSION)
K781057 · IYE
Varian Assoc., Inc.
Radiology · 24d
Cleared Jul 17, 1978
PLURIMAT
K781065 · IYB
Tecnomed, Inc.
Radiology · 21d
Cleared Jul 17, 1978
PLURIX C
K781066 · IXQ
Tecnomed, Inc.
Radiology · 21d
Cleared Jul 17, 1978
PLURIX B
K781067 · IXQ
Tecnomed, Inc.
Radiology · 21d
Cleared Jul 17, 1978
AUTOMATIC FILM PROCESSORIO M. R80
K781068 · IWX
Tecnomed, Inc.
Radiology · 21d
Cleared Jul 17, 1978
SONOGRAF ULTRASOUND B-SCANNING SYSTEM
K781079 · IYO
Ohio Nuclear, Inc.
Radiology · 19d
Cleared Jul 17, 1978
ASSURE NATURAL FIT TAMPON
K781085 · HIL
Personal Products Co.
Obstetrics & Gynecology · 18d
Cleared Jul 17, 1978
ONE INCISION BI-POLAR ELECTRO. FORCEPS
K781089 · HIN
Kli
Obstetrics & Gynecology · 18d
Cleared Jul 17, 1978
KNEE INSTRUMENTATION, CONDYLAR
K781091 · HWT
Biomet, Inc.
Orthopedic · 14d
Cleared Jul 17, 1978
HEARING AID, EYEGLASS
K781094 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 17d
Cleared Jul 17, 1978
HEARING AID, BEHIND THE EAR
K781095 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 17d
Cleared Jul 17, 1978
HEARING AID, EYEGLASS, B-12
K781096 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 17d
Cleared Jul 17, 1978
ELECTROSURGICAL UNIT 75
K781101 · GEI
Ritter Co.
General & Plastic Surgery · 14d
Cleared Jul 17, 1978
DISPENSER, GAS XENON
K781107 · IYT
Mallinckrodt Critical Care
Radiology · 17d
Cleared Jul 17, 1978
CAST WEDGE, YANCEY
K781112
Orthopedic Equipment Co., Inc.
Orthopedic · 14d
Cleared Jul 07, 1978
GENERATOR, PULSE, CARDIAC, IMPLANTABLE
K780421 · DXY
Telectronics, Inc.
Cardiovascular · 114d
Cleared Jul 07, 1978
SUTURELESS SKIN CLOSURE
K780565 · FPX
Abbott Laboratories
General & Plastic Surgery · 92d
Cleared Jul 07, 1978
GALVANATOR, MODEL 770
K781080 · IPF
Avra Corp.
Physical Medicine · 9d
Cleared Jul 07, 1978
CAST BLOCK
K781082 · JEB
Orthopedic Equipment Co., Inc.
General & Plastic Surgery · 8d
Cleared Jul 06, 1978
SET, ADMINISTRATION, MANUAL, DIALYSIS
K780957 · KDJ
American Medical Products, Inc.
Gastroenterology & Urology · 24d
Cleared Jun 30, 1978
STANICOR THETA MODEL 221 CARDIAC PACER
K780453 · DXY
Cordis Corp.
Cardiovascular · 102d