FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79801–79824 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2001
LDOB OCCLUSION BALLOON CATHETER
K002286 · MJN
Cook, Inc.
Cardiovascular · 238d
Cleared Mar 22, 2001
BLASTASSIST SYSTEM
K003156 · MQL
Medicult A/S
Obstetrics & Gynecology · 163d
Cleared Mar 22, 2001
SYNVITRO FLUSH
K003163 · MQL
Medicult A/S
Obstetrics & Gynecology · 163d
Cleared Mar 22, 2001
SUPRASPERM SYSTEM
K003404 · MQL
Medicult A/S
Obstetrics & Gynecology · 141d
Cleared Mar 22, 2001
ENDIUS BIPOLAR SHEATH
K003897 · GEI
Endius, Inc.
General & Plastic Surgery · 94d
Cleared Mar 22, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K003929 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 92d
Cleared Mar 22, 2001
DAUM DOUBLE-SHOOT BISOPSY GUN
K010037 · KNW
Daum GmbH
Gastroenterology & Urology · 77d
Cleared Mar 22, 2001
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
K010158 · GGO
Sigma Diagnostics, Inc.
Hematology · 64d
Cleared Mar 22, 2001
MCC-MIV ONE 2 ONE SOFTWARE
K010364 · ITI
Invacare Corp.
Physical Medicine · 43d
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