FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
171025–171048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 30, 1978
FECATEST
K780564 · KHE
Otto C. Watzka
Hematology · 85d
Cleared Jun 30, 1978
EXTERNAL TEST PULSE GENERATOR
K780717 · DTC
Vitatron Medical BV
Cardiovascular · 64d
Cleared Jun 30, 1978
ELECTRO-PLETHYSMOGRAPH
K780761 · JOM
Biotecx Laboratories, Inc.
Cardiovascular · 52d
Cleared Jun 30, 1978
MICROPULSE 22S PACEMAKER
K780780 · DXY
Edwards Pacemaker Systems
Cardiovascular · 50d
Cleared Jun 30, 1978
SAFETY STOP NECKSTRAP
K780814 · DYT
Northwest Orthodontics, Inc.
Dental · 43d
Cleared Jun 30, 1978
CONTACT LENS CLEANSER
K780823 · HPX
Ketchum Laboratories, Inc.
Ophthalmic · 39d