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
123073–123096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 1990
COOL CAST(R)
K903946 · LGF
Hawthorne Products, Inc.
Orthopedic · 126d
Cleared Dec 31, 1990
VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES
K904560 · GEI
Valleylab, Inc.
General & Plastic Surgery · 87d
Cleared Dec 31, 1990
FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM
K904795 · GKH
Bd Becton Dickinson Vacutainer...
Hematology · 73d
Cleared Dec 31, 1990
PRIDE SPIRIT
K905271 · INI
Pride Health Care, Inc.
Physical Medicine · 40d
Cleared Dec 31, 1990
ROMFLEX REHABILITATION EQUIPMENT
K905299 · BXB
Dyna Flex, Intl.
Physical Medicine · 33d
Cleared Dec 31, 1990
LINGRAPHICA VISUAL LANGUAGE PROSTHESIS
K905576 · ILQ
Tolfa Corp.
Physical Medicine · 19d
Cleared Dec 31, 1990
NONABSORBABLE POLYPROPYLENE SURGICAL MESH
K905655 · FTL
United States Surgical, A Division of...
General & Plastic Surgery · 13d
Cleared Dec 31, 1990
BRODA WHEELCHAIR
K905671 · IOR
Broda Ent., Inc.
Physical Medicine · 13d
Cleared Dec 28, 1990
RESP-EZ(TM) RESPIRATORY MONITORING BELT
K903300 · BZQ
Epm Information Systems, Inc.
Anesthesiology · 157d
Cleared Dec 28, 1990
OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING
K903844 · JXG
Cordis Corp.
Neurology · 129d
Cleared Dec 28, 1990
MEASLES IGG MICROASSAY
K903961 · LJB
Diamedix Corp.
Microbiology · 122d
Cleared Dec 28, 1990
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K904403 · FRN
C.R. Bard, Inc.
General Hospital · 94d
Cleared Dec 28, 1990
GLASSMAN STONE EXTRACTION SET
K904472 · LQR
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Dec 28, 1990
FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET
K904545 · GEI
Valleylab, Inc.
General & Plastic Surgery · 85d
Cleared Dec 28, 1990
MICROFLO
K904557 · EXY
Life-Tech Intl., Inc.
Gastroenterology & Urology · 84d
Cleared Dec 28, 1990
PALEX IRRIGATION SET
K904586 · EXD
Palex Intl. SA
Gastroenterology & Urology · 80d
Cleared Dec 28, 1990
EUROSUN MODELS - ES-2400, ES-VHO AND ES-16
K904644 · LEJ
Eurosun, Inc.
General & Plastic Surgery · 78d
Cleared Dec 28, 1990
HENNSON INTERNATIONAL DENTAL CAD/CAM SYSTEM
K904927 · ELW
Hennson Intl., Inc.
Dental · 58d
Cleared Dec 28, 1990
BIO-GUARD SHAVE PREP TRAY
K905003 · KME
Network Medical Systems, Inc.
General Hospital · 51d
Cleared Dec 28, 1990
SURGITEK ERECTEK TM EXTERNAL ERECTION DEVICE
K905015 · LKY
Surgitek
Gastroenterology & Urology · 51d
Cleared Dec 28, 1990
COAGULATION REFERENCE PLASMA, NORMAL
K905203 · GIZ
Medical Diagnostic Technologies, Inc.
Hematology · 38d
Cleared Dec 28, 1990
MEMORYMATE MODEL 8270 ITE HEARING AID
K905483 · ESD
3M Company
Ear, Nose, Throat · 22d
Cleared Dec 28, 1990
ALKALINE PHOSPHATASE
K905684 · CJE
Amresco, Inc.
Chemistry · 9d
Cleared Dec 27, 1990
FIRST MEDIC MODEL 510
K896903 · LDD
Spacelabs, Inc.
Cardiovascular · 384d