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
79297–79320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2001
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
K010497 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 29d
Cleared Mar 22, 2001
MODIFICATION TO SYNERGY SPINAL SYSTEM
K010515 · KWP
Interpore Cross Intl.
Orthopedic · 28d
Cleared Mar 21, 2001
TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
K002507 · DYB
Arrow Intl., Inc.
Cardiovascular · 218d
Cleared Mar 21, 2001
WHITTLESTONE BREASTPUMP
K002696 · HGX
Whittlestone, Inc.
Obstetrics & Gynecology · 203d
Cleared Mar 21, 2001
MEDEVIEW SYSTEM
K002789 · LLZ
Medeview.Com
Radiology · 195d
Cleared Mar 21, 2001
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
K003553 · FOZ
Bd Becton Dickinson Vacutainer...
General Hospital · 124d
Cleared Mar 21, 2001
VENTURE HOME FILL II, MODEL IOH 200
K003939 · CAW
Invacare Corp.
Anesthesiology · 90d
Cleared Mar 21, 2001
PECTOFIX STERNAL REPAIR WIRE
K003951 · JDQ
Pectofix, Inc.
Orthopedic · 90d
Cleared Mar 21, 2001
DJ ORTHOPEDICS TIBIAL ANCHOR
K003960 · MBI
Dj Orthopedics, LLC
Orthopedic · 90d
Cleared Mar 21, 2001
AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR
K003971 · MBI
Axya Medical, Inc.
Orthopedic · 89d
Cleared Mar 21, 2001
IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK
K010058 · LLZ
Witt Biomedical Corporation
Radiology · 72d
Cleared Mar 21, 2001
OHMEDA MEDICAL GIRAFFE INCUBATOR
K010222 · FMZ
Ohmeda Medical
General Hospital · 56d
Cleared Mar 21, 2001
KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C
K010686 · DXQ
Golden Horse Medical Equipment (Wuxi)...
Cardiovascular · 13d
Cleared Mar 20, 2001
PM 1800 CONSERVING DEVICE
K001412 · NFB
Precision Medical, Inc.
Anesthesiology · 320d
Cleared Mar 20, 2001
ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
K001535 · KWP
Ortho Tec, LLC
Orthopedic · 307d
Cleared Mar 20, 2001
LACTOSORB 5.0 MM WASHER
K001581 · HWC
Biomet, Inc.
Orthopedic · 302d
Cleared Mar 20, 2001
FS ACTIVATOR III
K003185 · LXM
Activator Methods International, Ltd.
Physical Medicine · 160d
Cleared Mar 20, 2001
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K003271 · DZE
Institut Straumann AG
Dental · 153d
Cleared Mar 20, 2001
ESCREEN SYSTEM
K003352 · LAF
Escreen, Inc.
Toxicology · 145d
Cleared Mar 20, 2001
APEX MODULAR ZIRCONIA FEMORAL HEAD
K003923 · LZO
Apex Surgical, LLC
Orthopedic · 90d
Cleared Mar 20, 2001
NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
K010031 · KTB
Wescor, Inc.
Physical Medicine · 76d
Cleared Mar 20, 2001
MODIFICATION TO TRIDENT ALL POLY CUP
K010310 · JDI
Howmedica Osteonics Corp.
Orthopedic · 47d
Cleared Mar 20, 2001
ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM
K010482 · JOP
Echocath, Inc.
Cardiovascular · 28d
Cleared Mar 20, 2001
WRISTWATCH BLOOD PRESSURE MONITOR A46
K010498 · DXN
Rossmax Internationl , Ltd.
Cardiovascular · 27d