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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
118153–118176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 05, 1992
DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
K912783 · GXZ
Class A Ent.
Neurology · 226d
Cleared Feb 05, 1992
QUALTEX SURGICAL DRAPE, MODIFICATION
K913486 · KKX
Deroyal Industries, Inc.
General Hospital · 183d
Cleared Feb 05, 1992
RIWOLITH 2280
K913487 · FFK
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 183d
Cleared Feb 05, 1992
DISPOSABLE OPTICAL VALVULOTOME
K914457 · MGZ
Nobles-Lai Engineering, Inc.
Cardiovascular · 121d
Cleared Feb 05, 1992
WETTING SOLUTION FOR HARD CONTACT LENSES
K914483 · LPN
Optopics Laboratories Corp.
Ophthalmic · 120d
Cleared Feb 05, 1992
IRRIGATOR/ASPIRATOR PROBE
K915074 · HMX
Biomedical Dynamics, Inc.
Ophthalmic · 89d
Cleared Feb 05, 1992
MODEL 2250-000 ZIMMER STYLE SAGITTAL SAW MODULE
K915139 · HSZ
Micro Surgical Instruments Corp.
Orthopedic · 84d
Cleared Feb 05, 1992
CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)
K915246 · EXI
Coloplast A/S
Gastroenterology & Urology · 82d
Cleared Feb 05, 1992
BUR,DENTAL (76EJL)
K915597 · DZE
Calcitek, Inc.
Dental · 54d
Cleared Feb 04, 1992
OSCOR MEDICAL CORP PERMANENT PACING LEAD
K912867 · DTB
Oscor Medical Corp.
Cardiovascular · 221d
Cleared Feb 04, 1992
MEDGRAPHICS PF/DX
K912906 · BZL
Medical Graphics Corp.
Anesthesiology · 217d
Cleared Feb 04, 1992
CT 8000 DIGITAL INJECTION SYSTEM
K912944 · DXT
Mallinckrodt Group, Inc.
Cardiovascular · 214d
Cleared Feb 04, 1992
MONARCH(TM) INFLATION SYRINGE
K913994 · MAV
Merit Medical Systems, Inc.
Cardiovascular · 151d
Cleared Feb 04, 1992
DXS DIGITAL X-RAY SUBTRACTION
K914376 · IZI
Philips Medical Systems (Cleveland),...
Radiology · 126d
Cleared Feb 04, 1992
P1310 AUTOMATIC BRIGHTNESS STABILIZER (ABS)
K915405 · JAA
Precise Optics Photo Medic Equipment,...
Radiology · 64d
Cleared Feb 04, 1992
TERUMO ANGIOGTAPHIC CATHETER
K915414 · DQO
Terumo Medical Corp.
Cardiovascular · 64d
Cleared Feb 04, 1992
AVIVA MAMMOGRAPHIC X-RAY SYSTEM
K915748 · IZH
Elscint, Inc.
Radiology · 43d
Cleared Feb 03, 1992
THORACIC ANTERIOR SPINAL FIXATION PLATE
K910874 · KWQ
Terray Manufacturing, Inc.
Orthopedic · 339d
Cleared Feb 03, 1992
MINI-PACK 911 SERIES
K912835 · MHX
Pace Tech, Inc.
Cardiovascular · 222d
Cleared Feb 03, 1992
TROJAN (TM-TBD) CONDOM
K912901 · HIS
Carter Products
Obstetrics & Gynecology · 216d
Cleared Feb 03, 1992
WILDE DENTURE RESINS
K912993 · EBI
Wilde-USA, Inc.
Dental · 210d
Cleared Feb 03, 1992
MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE
K912996 · IXR
Continental X-Ray Corp.
Radiology · 210d
Cleared Feb 03, 1992
NON REBREATHING VALVE
K913163 · CBP
Specialty Packaging Producs, Inc.
Anesthesiology · 201d
Cleared Feb 03, 1992
GTI CLASP COVER
K913200 · EBF
Gti, Inc.
Dental · 201d