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
122905–122928 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 18, 1991
PM GLOVE
K905055 · LYZ
Pm Gloves, Inc.
General Hospital · 72d
Cleared Jan 18, 1991
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS
K905229 · FGE
Arrow Intl., Inc.
Gastroenterology & Urology · 59d
Cleared Jan 18, 1991
ELITE 5000
K905501 · IXR
Fischer Imaging Corp.
Radiology · 42d
Cleared Jan 18, 1991
ILLUMINA MODEL 780 CO2 LASER SYSTEM
K905637 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 32d
Cleared Jan 18, 1991
ALADERM
K905678 · LYY
Aladan Corp.
General Hospital · 30d
Cleared Jan 18, 1991
ZENITH COX FLEXION CHIROPRACTIC TABLE
K905685 · INQ
Williams Manufacturing Co.
Physical Medicine · 30d
Cleared Jan 18, 1991
GENNY DENNY IV SHIELD
K905735 · KMK
Tadco, Inc.
General Hospital · 25d
Cleared Jan 18, 1991
ATI MEDICAL COMFORT PLUS CPM PAD
K910026 · BXB
Ati Medical, Inc.
Physical Medicine · 15d
Cleared Jan 18, 1991
ROMFLEX REHAB EQUIP LATERAL FLEXION UNIT
K910149 · BXB
Dyna Flex, Intl.
Physical Medicine · 4d
Cleared Jan 18, 1991
ROMFLEX REHAB EQUIP CERVICAL FLEXOR UNIT
K910151 · BXB
Dyna Flex, Intl.
Physical Medicine · 4d
Cleared Jan 17, 1991
MAGNETIC RESONANCE THERAPY DEVICE
K903675 · ILX
Mrt, Inc.
Physical Medicine · 157d
Cleared Jan 17, 1991
DE-TOX TUBES A AND DE-TOX TUBES B
K904326 · DPA
Dyna-Tek Industries
Toxicology · 119d
Cleared Jan 17, 1991
DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176
K904468 · CIG
Amresco, Inc.
Chemistry · 108d
Cleared Jan 17, 1991
THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM
K904816 · CDX
Bd Becton Dickinson Vacutainer...
Toxicology · 85d
Cleared Jan 17, 1991
SHBG IRMA KIT
K905247 · CDZ
Ventrex Laboratories, Inc.
Chemistry · 57d
Cleared Jan 17, 1991
WILL-CERAM BRUSHES, SUPER BRUSH KIT
K905328 · EIH
Ivoclar North America, Inc.
Dental · 50d
Cleared Jan 17, 1991
AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP
K905379 · GAR
United States Surgical, A Division of...
General & Plastic Surgery · 48d
Cleared Jan 17, 1991
CREATINE KINASE UV REAGENT SET
K905588 · JHW
Biochemical Trade, Inc.
Chemistry · 35d
Cleared Jan 17, 1991
ECLIPSE ICA TRIGLYCERIDES
K905601 · CDT
Biotope, Inc.
Chemistry · 35d
Cleared Jan 17, 1991
CEDIA PHENYTOIN ASSAY
K905689 · DIP
Microgenics Corp.
Toxicology · 29d
Cleared Jan 17, 1991
ECLIPSE ICA DIGOXIN
K905719 · DPO
Biotope, Inc.
Toxicology · 27d
Cleared Jan 17, 1991
ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS
K910086 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 9d
Cleared Jan 16, 1991
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
K902674 · DQR
Datascope Corp.
Cardiovascular · 212d
Cleared Jan 16, 1991
CYTOASPIRATOR
K902910 · FCK
H & B Medical Technology, Inc.
Gastroenterology & Urology · 198d