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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68977–69000 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 2004
DIAPEX
K033585 · KIF
Bisco, Inc.
Dental · 64d
Cleared Jan 16, 2004
ARTIC
K033628 · ELM
Heraeus Kulzer, Inc.
Dental · 58d
Cleared Jan 16, 2004
E.P.T. PREGNANCY TEST
K033658 · LCX
Unipath , Ltd.
Chemistry · 56d
Cleared Jan 16, 2004
POWDERED VINYL EXAMINATION GLOVES
K033692 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 53d
Cleared Jan 16, 2004
POWDER-FREE VINYL EXAMINATION GLOVES
K033693 · LYZ
Shen Wei (Usa), Inc.
General Hospital · 53d
Cleared Jan 16, 2004
PVS PIVOT STEERABLE DELIVERY SYSTEM MICROCATHETER
K033726 · KRA
Precision Vascular
Cardiovascular · 49d
Cleared Jan 16, 2004
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVE, WHITE COLOR
K033877 · LYZ
One Touch Products Co., Ltd.
General Hospital · 32d
Cleared Jan 16, 2004
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION...
K033903 · MQH
Cook Urological, Inc.
Obstetrics & Gynecology · 30d
Cleared Jan 16, 2004
PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES)
K033904 · MQH
Cook Urological, Inc.
Obstetrics & Gynecology · 30d
Cleared Jan 16, 2004
MODIFICATION TO SERAQUEST EB VCA IGG
K033915 · LSE
Quest Intl., Inc.
Microbiology · 29d
Cleared Jan 15, 2004
BIODHOC
K024185 · HTY
Future Medical Systems, SA
Orthopedic · 392d
Cleared Jan 15, 2004
EEG MONITOR WITH BIS, MODEL A-2000
K030267 · OLW
Aspect Medical Systems, Inc.
Neurology · 353d
Cleared Jan 15, 2004
B-SMART, MODEL B-01
K031128 · CAZ
Macosta Medical USA, LLC
Anesthesiology · 281d
Cleared Jan 15, 2004
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
K032108 · MBH
Aesculap, Inc.
Orthopedic · 191d
Cleared Jan 15, 2004
TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT
K032891 · HRX
Trans1, Inc.
Orthopedic · 120d
Cleared Jan 15, 2004
GOLD DENTAL CASTING ALLOYS
K033279 · EJT
Bego U.S.A.
Dental · 97d
Cleared Jan 15, 2004
REMEEX SYSTEM FOR URINARY INCONTINENCE
K033310 · OTN
Specialities Remeex International, S.L.
Gastroenterology & Urology · 93d
Cleared Jan 15, 2004
SCORPIO KNEE SYSTEM - TIBIAL INSERTS
K033342 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Jan 15, 2004
UGYTEX MESH
K033376 · FTL
Sofradim Production
General & Plastic Surgery · 85d
Cleared Jan 15, 2004
SMALL BONE FIXATION SYSTEM
K033406 · HTY
Hand Innovations, Inc.
Orthopedic · 83d
Cleared Jan 15, 2004
REVOLIX LASER SYSTEMS
K033423 · GEX
Allmed Systems, Inc.
General & Plastic Surgery · 80d
Cleared Jan 15, 2004
LEXATITE QUICK ACRYLIC
K033432 · EBG
Imtec Corp.
Dental · 79d
Cleared Jan 15, 2004
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
K033455 · GZJ
Biomedical Life Systems, Inc.
Neurology · 77d
Cleared Jan 15, 2004
EARLY CLEAVAGE MEDIUM (ECM)
K033462 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 76d