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
98305–98328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1996
COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS
K960032 · GEX
Coherent Medical Group
General & Plastic Surgery · 90d
Cleared Apr 01, 1996
TRUE TRIGLYCERIDE
K960088 · CDT
Diagnostic Chemicals , Ltd.
Chemistry · 81d
Cleared Apr 01, 1996
UNIMARK MIDSTREAM PREGNANCY TEST STICK
K960174 · LCX
Biotech Atlantic, Inc.
Chemistry · 76d
Cleared Apr 01, 1996
CPR IRRIGATION TRAY
K960212 · KYZ
Custom Pack Reliability
General Hospital · 76d
Cleared Apr 01, 1996
CPR FOLEY CAHTETER KIT
K960214 · FCM
Custom Pack Reliability
Gastroenterology & Urology · 76d
Cleared Apr 01, 1996
CPR URETHRAL CATHETER TRAY
K960215 · FCM
Custom Pack Reliability
Gastroenterology & Urology · 76d
Cleared Apr 01, 1996
WHEELCHAIR ELEVATOR
K960276 · ING
Services Industriels Savaria, Inc.
Physical Medicine · 73d
Cleared Apr 01, 1996
CONSENSUS ACETABULAR SHELL, ALL UHMWPE
K960302 · JDI
U.S. Medical Products, Inc.
Orthopedic · 70d
Cleared Apr 01, 1996
UROSPROBE SYSTEM, MODEL 1000
K960387 · GEH
Uros Corp.
General & Plastic Surgery · 66d
Cleared Apr 01, 1996
DYNAREX NON-WOVEN SPONGE
K960388 · EFQ
Dynarex Corp.
General & Plastic Surgery · 66d
Cleared Apr 01, 1996
DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE...
K960456 · KDD
Denver Biomaterials, Inc.
General & Plastic Surgery · 62d
Cleared Apr 01, 1996
SOFT TISSUE AUGMENTATION TUBE
K960481 · FTL
Tissue Technologies, Inc.
General & Plastic Surgery · 59d
Cleared Apr 01, 1996
EXPANDACELL INSTRUMENT WIPE
K960621 · GEC
Shippert Medical Technologies Corp.
General & Plastic Surgery · 48d
Cleared Apr 01, 1996
V-1504 VERTICAL PLATFORM LIFT
K960739 · ING
Barnes,Richardson & Colburn
Physical Medicine · 38d
Cleared Mar 29, 1996
MINI WRIGHT LR AFS
K952713 · BZH
Clement Clarke, Inc.
Anesthesiology · 289d
Cleared Mar 29, 1996
AUTOZONE
K952909 · BZH
Health Scan, Inc.
Anesthesiology · 280d
Cleared Mar 29, 1996
SBDX MOBILE FLUOROSCOPY SYSTEM
K953113 · JAA
Cardiac Mariners, Inc.
Radiology · 270d
Cleared Mar 29, 1996
BREEZE DIGITAL INFLATION DEVICE
K953676 · MAV
Namic
Cardiovascular · 235d
Cleared Mar 29, 1996
BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY
K954397 · DPW
Koven Technology, Inc.
Radiology · 191d
Cleared Mar 29, 1996
EVIS 140 SYSTEM
K954451 · FET
Olympus America, Inc.
Gastroenterology & Urology · 186d
Cleared Mar 29, 1996
ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM
K954691 · LMD
Access Radiology Corp.
Radiology · 170d
Cleared Mar 29, 1996
PERCUTANEOUS REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY (MODIFICATION)
K954879 · KNT
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 168d
Cleared Mar 29, 1996
CB DIODE/532 LASER SYSTEM
K954905 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 156d
Cleared Mar 29, 1996
XENON OPTION TO PRISM 3000
K955484 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 119d